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A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03525678
Recruitment Status : Active, not recruiting
First Posted : May 16, 2018
Results First Posted : April 28, 2020
Last Update Posted : August 10, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: GSK2857916 frozen liquid
Drug: GSK2857916 lyophilized powder
Enrollment 221
Recruitment Details This was a Phase II, open-label, randomized, multicenter study to evaluate the efficacy and safety of belantamab mafodotin monotherapy at a dose of 2.5 milligram per kilogram (mg/kg) or 3.4 mg/kg, given intravenously (IV) in participants with relapsed/refractory multiple myeloma (RRMM).
Pre-assignment Details A total of 293 participants were screened and 221 participants were enrolled and randomized in this study. The results presented are based on the interim analysis.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline. Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline. Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Period Title: Overall Study
Started 97 99 25
Received Study Treatment [1] 95 99 24
Completed 0 0 0
Not Completed 97 99 25
Reason Not Completed
Ongoing at the time of interim analysis             60             65             21
Withdrawal by Subject             3             1             0
Physician Decision             1             2             0
Lost to Follow-up             1             0             0
Death             32             31             4
[1]
3 randomized participants never received treatment (2-withdrawal by physician decision and 1-death).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized) Total
Hide Arm/Group Description Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline. Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline. Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection. Total of all reporting groups
Overall Number of Baseline Participants 97 99 25 221
Hide Baseline Analysis Population Description
Baseline characteristics were presented for all randomized participants including 3 randomized participants who never received treatment (2-withdrawal by physician decision and 1-death).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 97 participants 99 participants 25 participants 221 participants
64.1  (10.01) 66.0  (9.09) 67.2  (10.78) 65.3  (10.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 99 participants 25 participants 221 participants
Female
46
  47.4%
43
  43.4%
11
  44.0%
100
  45.2%
Male
51
  52.6%
56
  56.6%
14
  56.0%
121
  54.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 99 participants 25 participants 221 participants
Black or African American
16
  16.5%
11
  11.1%
3
  12.0%
30
  13.6%
Asian - Central/South Asian Heritage
1
   1.0%
0
   0.0%
0
   0.0%
1
   0.5%
Asian - East Asian Heritage
1
   1.0%
0
   0.0%
0
   0.0%
1
   0.5%
Asian - South East Asian Heritage
0
   0.0%
1
   1.0%
1
   4.0%
2
   0.9%
White - Arabic/North African Heritage
4
   4.1%
2
   2.0%
0
   0.0%
6
   2.7%
White - White/Caucasian/European Heritage
72
  74.2%
83
  83.8%
21
  84.0%
176
  79.6%
Mixed Asian Race
0
   0.0%
1
   1.0%
0
   0.0%
1
   0.5%
Mixed White Race
0
   0.0%
1
   1.0%
0
   0.0%
1
   0.5%
Unknown
1
   1.0%
0
   0.0%
0
   0.0%
1
   0.5%
Missing
2
   2.1%
0
   0.0%
0
   0.0%
2
   0.9%
1.Primary Outcome
Title Overall Response Rate (ORR) by Independent Review Committee (IRC) (Full Analysis Population)
Hide Description ORR was determined according to the 2016 international myeloma working group (IMWG) response criteria by IRC. ORR was calculated as the percentage of participants with a confirmed partial response (PR) or better (that is [i.e.], PR, very good partial response [VGPR], complete response [CR] and stringent complete response [sCR]). Confidence intervals were based on the exact method.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population comprised of all randomized participants (any participant who received a treatment randomization number was considered as randomized) whether or not randomized treatment was administered. This population was based on the treatment the participant was randomized to.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 97 99 25
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: Percentage of Participants
31
(20.8 to 42.6)
34
(23.9 to 46.0)
48
(25.5 to 71.1)
2.Primary Outcome
Title Overall Response Rate by Independent Review Committee (Efficacy Population)
Hide Description ORR was determined according to the 2016 IMWG response criteria by IRC. ORR was calculated as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR). Confidence intervals were based on the exact method. Efficacy Population comprised of first 130 intent-to-treat participants whether or not randomized treatment (frozen solution) was administered. Intent-to-treat Population comprised of all randomized participants whether or not randomized treatment was administered.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Overall Number of Participants Analyzed 64 66
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
30
(18.9 to 42.4)
30
(19.6 to 42.9)
3.Secondary Outcome
Title Overall Response Rate by Investigator Assessment (IA) (Full Analysis Population)
Hide Description ORR was determined by the investigator according to the 2016 IMWG response criteria. ORR was calculated as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR). Confidence intervals were based on the exact method.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 97 99 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
30
(21.0 to 40.0)
31
(22.4 to 41.4)
52
(31.3 to 72.2)
4.Secondary Outcome
Title Overall Response Rate by Investigator Assessment (Efficacy Population)
Hide Description ORR was determined by the investigator according to the 2016 IMWG response criteria. ORR was calculated as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR). Confidence intervals were based on the exact method.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Overall Number of Participants Analyzed 64 66
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
30
(18.9 to 42.4)
26
(15.8 to 38.0)
5.Secondary Outcome
Title Clinical Benefit Rate (CBR) by Investigator Assessment (Full Analysis Population)
Hide Description CBR was determined by the investigator according to the 2016 IMWG response criteria. CBR was calculated as the percentage of participants with a confirmed minimal response (MR) or better (i.e., MR, PR, VGPR, CR and sCR). Confidence intervals were based on the exact method.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 97 99 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
34
(24.7 to 44.3)
37
(27.9 to 47.7)
56
(34.9 to 75.6)
6.Secondary Outcome
Title Clinical Benefit Rate by Investigator Assessment (Efficacy Population)
Hide Description CBR was determined by the investigator according to the 2016 IMWG response criteria. CBR was calculated as the percentage of participants with a confirmed MR or better (i.e., MR, PR, VGPR, CR and sCR). Confidence intervals were based on the exact method.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Overall Number of Participants Analyzed 64 66
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
34
(22.9 to 47.3)
33
(22.2 to 46.0)
7.Secondary Outcome
Title Clinical Benefit Rate by Independent Review Committee (Full Analysis Population)
Hide Description CBR was determined according to the 2016 IMWG response criteria by IRC. CBR was calculated as the percentage of participants with a confirmed MR or better (i.e., MR, PR, VGPR, CR and sCR). Confidence intervals were based on the exact method.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 97 99 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
34
(24.7 to 44.3)
39
(29.7 to 49.7)
52
(31.3 to 72.2)
8.Secondary Outcome
Title Clinical Benefit Rate by Independent Review Committee (Efficacy Population)
Hide Description CBR was determined according to the 2016 IMWG response criteria by IRC. CBR was calculated as the percentage of participants with a confirmed MR or better (i.e., MR, PR, VGPR, CR and sCR). Confidence intervals were based on the exact method.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Overall Number of Participants Analyzed 64 66
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
33
(21.6 to 45.7)
36
(24.9 to 49.1)
9.Secondary Outcome
Title Duration of Response (DoR) by Investigator Assessment (Full Analysis Population)
Hide Description DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented disease progression (PD) per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 29 31 13
Median (Inter-Quartile Range)
Unit of Measure: Months
NA [1] 
(4.2 to NA)
NA [2] 
(NA to NA)
NA [1] 
(2.8 to NA)
[1]
<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived.
[2]
<25% of participants experienced the event within the treatment arm. Hence, median and inter-quartile range could not be derived.
10.Secondary Outcome
Title Duration of Response by Investigator Assessment (Efficacy Population)
Hide Description DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented PD per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Overall Number of Participants Analyzed 19 17
Median (Inter-Quartile Range)
Unit of Measure: Months
NA [1] 
(4.1 to NA)
NA [2] 
(NA to NA)
[1]
<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived.
[2]
<25% of participants experienced the event within the treatment arm. Hence, median and inter-quartile range could not be derived.
11.Secondary Outcome
Title Duration of Response by Independent Review Committee (Full Analysis Population)
Hide Description DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented PD per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 30 34 12
Median (Inter-Quartile Range)
Unit of Measure: Months
NA [1] 
(4.2 to NA)
NA [1] 
(4.7 to NA)
NA [1] 
(3.4 to NA)
[1]
<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived.
12.Secondary Outcome
Title Duration of Response by Independent Review Committee (Efficacy Population)
Hide Description DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented PD per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Overall Number of Participants Analyzed 19 20
Median (Inter-Quartile Range)
Unit of Measure: Months
NA [1] 
(4.0 to NA)
NA [1] 
(4.7 to NA)
[1]
<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived.
13.Secondary Outcome
Title Time to Response by Investigator Assessment (Full Analysis Population)
Hide Description Time to response is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better). Time to response based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of time to response are presented.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 29 31 13
Median (Inter-Quartile Range)
Unit of Measure: Months
1.4
(0.8 to 2.1)
1.5
(0.9 to 3.0)
0.9
(0.8 to 1.0)
14.Secondary Outcome
Title Time to Response by Investigator Assessment (Efficacy Population)
Hide Description Time to response is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better). Time to response based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of time to response are presented.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Overall Number of Participants Analyzed 19 17
Median (Inter-Quartile Range)
Unit of Measure: Months
1.4
(0.8 to 2.2)
1.5
(1.4 to 2.8)
15.Secondary Outcome
Title Time to Response by Independent Review Committee (Full Analysis Population)
Hide Description Time to response is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better). Time to response based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of time to response are presented.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 30 34 12
Median (Inter-Quartile Range)
Unit of Measure: Months
1.4
(0.8 to 2.1)
1.4
(0.8 to 2.8)
0.9
(0.8 to 1.6)
16.Secondary Outcome
Title Time to Response by Independent Review Committee (Efficacy Population)
Hide Description Time to response is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better). Time to response based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of time to response are presented.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Overall Number of Participants Analyzed 19 20
Median (Inter-Quartile Range)
Unit of Measure: Months
1.5
(0.8 to 2.2)
1.4
(1.1 to 1.9)
17.Secondary Outcome
Title Progression Free Survival by Investigator Assessment
Hide Description Progression free survival is defined as the time from randomization until the earliest date of documented PD per IMWG, or death due to any cause. Progression free survival based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of progression free survival are presented.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 97 99 25
Median (Inter-Quartile Range)
Unit of Measure: Months
2.2 [1] 
(0.8 to NA)
3.8 [1] 
(1.1 to NA)
4.3 [1] 
(2.1 to NA)
[1]
<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.
18.Secondary Outcome
Title Progression Free Survival by Independent Review Committee
Hide Description Progression free survival is defined as the time from randomization until the earliest date of documented PD per IMWG, or death due to any cause. Progression free survival based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of progression free survival are presented.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 97 99 25
Median (Inter-Quartile Range)
Unit of Measure: Months
2.9 [1] 
(0.9 to NA)
4.9 [1] 
(0.9 to NA)
NA [2] 
(2.2 to NA)
[1]
<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.
[2]
<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived.
19.Secondary Outcome
Title Time to Progression by Investigator Assessment
Hide Description Time to progression is defined as the time from randomization until the earliest date of documented PD per IMWG, or death due to PD. Time to Progression based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of time to progression are presented.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 97 99 25
Median (Inter-Quartile Range)
Unit of Measure: Months
2.3 [1] 
(0.8 to NA)
4.2 [1] 
(1.3 to NA)
4.3 [1] 
(2.1 to NA)
[1]
<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.
20.Secondary Outcome
Title Time to Progression by Independent Review Committee
Hide Description Time to progression is defined as the time from randomization until the earliest date of documented PD per IMWG, or death due to PD. Time to Progression based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of time to progression are presented.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 97 99 25
Median (Inter-Quartile Range)
Unit of Measure: Months
3.0 [1] 
(0.9 to NA)
5.8 [1] 
(0.9 to NA)
NA [2] 
(2.2 to NA)
[1]
<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.
[2]
<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived.
21.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the time from randomization until death due to any cause. Overall survival was analyzed using the Kaplan-Meier method by dose level. Median and inter-quartile range (first quartile and third quartile) of overall survival are presented.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 97 99 25
Median (Inter-Quartile Range)
Unit of Measure: Months
9.9 [1] 
(4.8 to NA)
9.7 [2] 
(6.4 to NA)
NA [3] 
(NA to NA)
[1]
<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived
[2]
<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.
[3]
<25% of participants experienced the event within the treatment arm. Hence, median and inter-quartile range could not be derived.
22.Secondary Outcome
Title Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
Hide Description Following parameters were assessed:basophils(Baso),eosinophils(Eosino),hematocrit(Hct),mean corpuscular hemoglobin(MCH),MCH concentration(MCHC),MC volume(MCV),monocyte(Mono),erythrocytes(Erythro),reticulocytes(Reticu).Baseline is latest pre-dose assessment(Day1)with a non-missing value, including unscheduled visits.Data was categorized as decrease to low(value below lower limit of normal range[LNR]),increase to high(value above upper LNR),change to normal/no change(NC).If values were unchanged(eg.high to high) or whose value became normal,were recorded in change to normal/NC category.Participants were counted twice if participant had both decreased to low/increased to high during post-Baseline(PB).Data for worst case PB is presented.Full Safety Population(FSP) comprised of all participants who received at least 1dose of study drug(frozen liquid or lyophilized powder). 3 out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Time Frame Baseline (Day 1) and Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Measure Type: Count of Participants
Unit of Measure: Participants
Baso, decrease to low, n=94,96,23 Number Analyzed 94 participants 96 participants 23 participants
2
   2.1%
6
   6.3%
0
   0.0%
Baso, change to normal or NC, n=94,96,23 Number Analyzed 94 participants 96 participants 23 participants
89
  94.7%
86
  89.6%
22
  95.7%
Baso, increase to high, n=94,96,23 Number Analyzed 94 participants 96 participants 23 participants
3
   3.2%
4
   4.2%
1
   4.3%
Eosino, decrease to low, n=95,97,23 Number Analyzed 95 participants 97 participants 23 participants
12
  12.6%
11
  11.3%
0
   0.0%
Eosino, change to normal or NC, n=95,97,23 Number Analyzed 95 participants 97 participants 23 participants
78
  82.1%
82
  84.5%
18
  78.3%
Eosino, increase to high, n=95,97,23 Number Analyzed 95 participants 97 participants 23 participants
5
   5.3%
6
   6.2%
5
  21.7%
Hct, decrease to low, n=95,97,24 Number Analyzed 95 participants 97 participants 24 participants
9
   9.5%
3
   3.1%
1
   4.2%
Hct, change to normal or NC, n=95,97,24 Number Analyzed 95 participants 97 participants 24 participants
86
  90.5%
94
  96.9%
23
  95.8%
Hct, increase to high, n=95,97,24 Number Analyzed 95 participants 97 participants 24 participants
1
   1.1%
0
   0.0%
0
   0.0%
MCH, decrease to low, n=95,95,21 Number Analyzed 95 participants 95 participants 21 participants
10
  10.5%
16
  16.8%
2
   9.5%
MCH, change to normal or NC, n=95,95,21 Number Analyzed 95 participants 95 participants 21 participants
83
  87.4%
71
  74.7%
18
  85.7%
MCH, increase to high, n=95,95,21 Number Analyzed 95 participants 95 participants 21 participants
2
   2.1%
9
   9.5%
1
   4.8%
MCHC, decrease to low, n=94,96,21 Number Analyzed 94 participants 96 participants 21 participants
19
  20.2%
25
  26.0%
4
  19.0%
MCHC, change to normal or NC, n=94,96,21 Number Analyzed 94 participants 96 participants 21 participants
73
  77.7%
71
  74.0%
17
  81.0%
MCHC, increase to high, n=94,96,21 Number Analyzed 94 participants 96 participants 21 participants
2
   2.1%
0
   0.0%
0
   0.0%
MCV, decrease to low, n=95,97,24 Number Analyzed 95 participants 97 participants 24 participants
9
   9.5%
12
  12.4%
1
   4.2%
MCV, change to normal or NC, n=95,97,24 Number Analyzed 95 participants 97 participants 24 participants
80
  84.2%
77
  79.4%
21
  87.5%
MCV, increase to high, n=95,97,24 Number Analyzed 95 participants 97 participants 24 participants
6
   6.3%
8
   8.2%
2
   8.3%
Mono, decrease to low, n=95,97,24 Number Analyzed 95 participants 97 participants 24 participants
6
   6.3%
8
   8.2%
0
   0.0%
Mono, change to normal or NC, n=95,97,24 Number Analyzed 95 participants 97 participants 24 participants
63
  66.3%
53
  54.6%
14
  58.3%
Mono, increase to high, n=95,97,24 Number Analyzed 95 participants 97 participants 24 participants
27
  28.4%
42
  43.3%
10
  41.7%
Erythro, decrease to low, n=95,97,24 Number Analyzed 95 participants 97 participants 24 participants
3
   3.2%
1
   1.0%
0
   0.0%
Erythro, change to normal or NC, n=95,97,24 Number Analyzed 95 participants 97 participants 24 participants
92
  96.8%
95
  97.9%
23
  95.8%
Erythro, increase to high, n=95,97,24 Number Analyzed 95 participants 97 participants 24 participants
1
   1.1%
1
   1.0%
1
   4.2%
Reticu, decrease to low, n=68,62,18 Number Analyzed 68 participants 62 participants 18 participants
7
  10.3%
11
  17.7%
5
  27.8%
Reticu, change to normal or NC, n=68,62,18 Number Analyzed 68 participants 62 participants 18 participants
50
  73.5%
37
  59.7%
6
  33.3%
Reticu, increase to high, n=68,62,18 Number Analyzed 68 participants 62 participants 18 participants
12
  17.6%
17
  27.4%
8
  44.4%
23.Secondary Outcome
Title Number of Participants With Grade Change From Baseline in Hematology Parameters
Hide Description Blood samples were collected for the analysis of following hematology parameters: hemoglobin (Hb), lymphocyte count (Lymph), neutrophil count (Neutro), platelet count (PC), and leukocyte count (leuko). The laboratory parameters were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case post Baseline is presented. Only those participants with increase to grade 3 and increase to grade 4 have been presented.
Time Frame Baseline (Day 1) and Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Measure Type: Count of Participants
Unit of Measure: Participants
Hb, Hb increased, increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
Hb, Hb increased, increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
Hb, Anemia, increase to Grade 3
17
  17.9%
28
  28.3%
4
  16.7%
Hb, Anemia, increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
Lymph, Lymph count increased, increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
Lymph, Lymph count increased, increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
Lymph, Lymph count decreased, increase to Grade 3
16
  16.8%
24
  24.2%
6
  25.0%
Lymph, Lymph count decreased, increase to Grade 4
5
   5.3%
5
   5.1%
0
   0.0%
Neutro, increase to Grade 3
4
   4.2%
11
  11.1%
2
   8.3%
Neutro, increase to Grade 4
5
   5.3%
2
   2.0%
1
   4.2%
PC, increase to Grade 3
8
   8.4%
12
  12.1%
1
   4.2%
PC, increase to Grade 4
12
  12.6%
23
  23.2%
2
   8.3%
Leuko, Leukocytosis, increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
Leuko, Leukocytosis, increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
Leuko, Leuko decreased, increase to Grade 3
5
   5.3%
9
   9.1%
1
   4.2%
Leuko, Leuko decreased, increase to Grade 4
3
   3.2%
2
   2.0%
0
   0.0%
24.Secondary Outcome
Title Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range
Hide Description Blood samples were collected for analysis of clinical chemistry parameters: bicarbonate, direct bilirubin(D.Bil), calcium, chloride, lactate dehydrogenase(LDH), total protein, urea or blood urea nitrogen(BUN),estimated glomerular filtration rate (eGFR).Baseline is latest pre-dose assessment(Day 1) with a non-missing value, including unscheduled visits. Number of participants with worst case clinical chemistry change from Baseline with respect to normal range are presented. Data was categorized as decrease to low (value below the lower LNR), increase to high (value above the upper LNR) and change to normal or NC. If values were unchanged (example: high to high), or whose value became normal, were recorded in the change to normal or NC category. Participants were counted twice if the participant had both decreased to low and increased to high during post Baseline. 3 out of 221participants did not receive any study treatment, were excluded from FSP.
Time Frame Baseline (Day 1) and Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Measure Type: Count of Participants
Unit of Measure: Participants
Bicarbonate, decrease to low, n=90,93,24 Number Analyzed 90 participants 93 participants 24 participants
8
   8.9%
19
  20.4%
3
  12.5%
Bicarbonate, change to normal or NC, n=90,93,24 Number Analyzed 90 participants 93 participants 24 participants
72
  80.0%
63
  67.7%
18
  75.0%
Bicarbonate, increase to high, n=90,93,24 Number Analyzed 90 participants 93 participants 24 participants
10
  11.1%
14
  15.1%
3
  12.5%
D.Bil, decrease to low, n=69,70,21 Number Analyzed 69 participants 70 participants 21 participants
0
   0.0%
1
   1.4%
0
   0.0%
D.Bil, change to normal or NC, n=69,70,21 Number Analyzed 69 participants 70 participants 21 participants
64
  92.8%
63
  90.0%
21
 100.0%
D.Bil, increase to high, n=69,70,21 Number Analyzed 69 participants 70 participants 21 participants
5
   7.2%
6
   8.6%
0
   0.0%
Calcium, decrease to low, n=95,98,24 Number Analyzed 95 participants 98 participants 24 participants
24
  25.3%
26
  26.5%
7
  29.2%
Calcium, change to normal or NC, n=95,98,24 Number Analyzed 95 participants 98 participants 24 participants
55
  57.9%
52
  53.1%
9
  37.5%
Calcium, increase to high, n=95,98,24 Number Analyzed 95 participants 98 participants 24 participants
25
  26.3%
23
  23.5%
8
  33.3%
Chloride, decrease to low, n=94,97,24 Number Analyzed 94 participants 97 participants 24 participants
15
  16.0%
12
  12.4%
2
   8.3%
Chloride, change to normal or NC, n=94,97,24 Number Analyzed 94 participants 97 participants 24 participants
66
  70.2%
65
  67.0%
20
  83.3%
Chloride, increase to high, n=94,97,24 Number Analyzed 94 participants 97 participants 24 participants
13
  13.8%
23
  23.7%
2
   8.3%
LDH, decrease to low, n=92,98,23 Number Analyzed 92 participants 98 participants 23 participants
1
   1.1%
1
   1.0%
0
   0.0%
LDH, change to normal or NC, n=92,98,23 Number Analyzed 92 participants 98 participants 23 participants
47
  51.1%
54
  55.1%
12
  52.2%
LDH, increase to high, n=92,98,23 Number Analyzed 92 participants 98 participants 23 participants
44
  47.8%
44
  44.9%
11
  47.8%
Protein, decrease to low, n=94,98,24 Number Analyzed 94 participants 98 participants 24 participants
29
  30.9%
27
  27.6%
8
  33.3%
Protein, change to normal or NC, n=94,98,24 Number Analyzed 94 participants 98 participants 24 participants
51
  54.3%
64
  65.3%
14
  58.3%
Protein, increase to high, n=94,98,24 Number Analyzed 94 participants 98 participants 24 participants
17
  18.1%
7
   7.1%
2
   8.3%
BUN, decrease to low, n=90,93,24 Number Analyzed 90 participants 93 participants 24 participants
10
  11.1%
13
  14.0%
0
   0.0%
BUN, change to normal or NC, n=90,93,24 Number Analyzed 90 participants 93 participants 24 participants
69
  76.7%
60
  64.5%
18
  75.0%
BUN, increase to high, n=90,93,24 Number Analyzed 90 participants 93 participants 24 participants
12
  13.3%
22
  23.7%
6
  25.0%
eGFR, decrease to low, n=51,67,19 Number Analyzed 51 participants 67 participants 19 participants
9
  17.6%
10
  14.9%
5
  26.3%
eGFR, change to normal or NC, n=51,67,19 Number Analyzed 51 participants 67 participants 19 participants
42
  82.4%
56
  83.6%
14
  73.7%
eGFR, increase to high, n=51,67,19 Number Analyzed 51 participants 67 participants 19 participants
0
   0.0%
1
   1.5%
1
   5.3%
25.Secondary Outcome
Title Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Hide Description Blood samples were collected for analysis of clinical chemistry parameters: glucose(Gl), albumin, alkaline phosphatase (ALP), alanine aminotransferase(ALT), aspartate aminotransferase(AST), total bilirubin(T.Bil), creatinine kinase (CK), creatinine, gamma glutamyl transferase (GGT), potassium (Pot), magnesium (Mg), sodium (Sod), phosphate (Ph) and urate. Values (Hyper and hypo) for Gl, Pot, Mg and Sod is presented. Laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade1: mild; Grade2: moderate; Grade3: severe or medically significant; Grade4: life-threatening consequences. Baseline is latest pre-dose assessment(Day 1) with a non-missing value, including unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case PB is presented. Only those participants with increase to grade3 and increase to grade4 have been presented. 3 out of 221participants did not receive any study treatment, were excluded from FSP.
Time Frame Baseline (Day 1) and Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Measure Type: Count of Participants
Unit of Measure: Participants
Gl, Hyper, increase to Grade 3, n=94,95,24 Number Analyzed 94 participants 95 participants 24 participants
3
   3.2%
4
   4.2%
0
   0.0%
Gl, Hyper, increase to Grade 4, n=94,95,24 Number Analyzed 94 participants 95 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Gl, Hypo, increase to Grade 3, n=94,95,24 Number Analyzed 94 participants 95 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Gl, Hypo, increase to Grade 4, n=94,95,24 Number Analyzed 94 participants 95 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Albumin, increase to Grade 3, n=94,98,24 Number Analyzed 94 participants 98 participants 24 participants
4
   4.3%
7
   7.1%
1
   4.2%
Albumin, increase to Grade 4, n=94,98,24 Number Analyzed 94 participants 98 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
ALP, increase to Grade 3, n=93,97,24 Number Analyzed 93 participants 97 participants 24 participants
1
   1.1%
0
   0.0%
0
   0.0%
ALP, increase to Grade 4, n=93,97,24 Number Analyzed 93 participants 97 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
ALT, increase to Grade 3, n=93,97,24 Number Analyzed 93 participants 97 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
ALT, increase to Grade 4, n=93,97,24 Number Analyzed 93 participants 97 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
AST, increase to Grade 3, n=93,96,24 Number Analyzed 93 participants 96 participants 24 participants
2
   2.2%
5
   5.2%
0
   0.0%
AST, increase to Grade 4, n=93,96,24 Number Analyzed 93 participants 96 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
T.Bil, increase to Grade 3, n=92,97,23 Number Analyzed 92 participants 97 participants 23 participants
0
   0.0%
0
   0.0%
0
   0.0%
T.Bil, increase to Grade 4, n=92,97,23 Number Analyzed 92 participants 97 participants 23 participants
0
   0.0%
0
   0.0%
0
   0.0%
CK, increase to Grade 3, n= 87,91,24 Number Analyzed 87 participants 91 participants 24 participants
0
   0.0%
0
   0.0%
1
   4.2%
CK, increase to Grade 4, n= 87,91,24 Number Analyzed 87 participants 91 participants 24 participants
1
   1.1%
0
   0.0%
0
   0.0%
Creatinine, increase to Grade 3, n= 95,97,24 Number Analyzed 95 participants 97 participants 24 participants
4
   4.2%
3
   3.1%
0
   0.0%
Creatinine, increase to Grade 4, n= 95,97,24 Number Analyzed 95 participants 97 participants 24 participants
1
   1.1%
0
   0.0%
0
   0.0%
GGT, increase to Grade 3, n= 91,95,24 Number Analyzed 91 participants 95 participants 24 participants
5
   5.5%
9
   9.5%
0
   0.0%
GGT, increase to Grade 4, n= 91,95,24 Number Analyzed 91 participants 95 participants 24 participants
0
   0.0%
1
   1.1%
0
   0.0%
Pot, Hyper,increase to Grade 3, n= 95,97,24 Number Analyzed 95 participants 97 participants 24 participants
0
   0.0%
1
   1.0%
0
   0.0%
Pot, Hyper,increase to Grade 4, n= 95,97,24 Number Analyzed 95 participants 97 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Pot, Hypo, increase to Grade 3, n= 95,97,24 Number Analyzed 95 participants 97 participants 24 participants
0
   0.0%
2
   2.1%
1
   4.2%
Pot, Hypo, increase to Grade 4, n= 95,97,24 Number Analyzed 95 participants 97 participants 24 participants
2
   2.1%
0
   0.0%
0
   0.0%
Mg, Hyper, increase to Grade 3, n= 91,96,24 Number Analyzed 91 participants 96 participants 24 participants
3
   3.3%
0
   0.0%
0
   0.0%
Mg, Hyper, increase to Grade 4, n= 91,96,24 Number Analyzed 91 participants 96 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Mg, Hypo, increase to Grade 3, n= 91,96,24 Number Analyzed 91 participants 96 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Mg, Hypo, increase to Grade 4, n= 91,96,24 Number Analyzed 91 participants 96 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Phosphate, increase to Grade 3, n= 90,93,24 Number Analyzed 90 participants 93 participants 24 participants
4
   4.4%
6
   6.5%
1
   4.2%
Phosphate, increase to Grade 4, n= 90,93,24 Number Analyzed 90 participants 93 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Sod, Hyper, increase to Grade 3, n= 95,97,24 Number Analyzed 95 participants 97 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Sod, Hyper, increase to Grade 4, n= 95,97,24 Number Analyzed 95 participants 97 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Sod, Hypo, increase to Grade 3, n= 95,97,24 Number Analyzed 95 participants 97 participants 24 participants
2
   2.1%
6
   6.2%
1
   4.2%
Sod, Hypo, increase to Grade 4, n= 95,97,24 Number Analyzed 95 participants 97 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Urate, increase to Grade 3, n= 93,96,24 Number Analyzed 93 participants 96 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Urate, increase to Grade 4, n= 93,96,24 Number Analyzed 93 participants 96 participants 24 participants
3
   3.2%
4
   4.2%
0
   0.0%
26.Secondary Outcome
Title Number of Participants With Abnormal Findings During Physical Examination
Hide Description Physical examination included assessment of the head, eyes, ears, nose, throat, skin, thyroid, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes, and extremities. This analysis was planned, but data was not collected and captured in the database.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Safety Population. This analysis was planned, but data was not collected and captured in the database.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
27.Secondary Outcome
Title Number of Participants With Change From Baseline in Pulse Rate
Hide Description Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with worst case change from Baseline in pulse rate is presented. Data is categorized as: pulse rate 'decrease to <60 beats per minute [bpm]', 'increase to >100 bpm' and 'change to normal or no change'. If values were unchanged (example: increase to >100 bpm to increase to >100 bpm), or whose value became normal, were recorded in the 'change to normal or no change' category. Participants were counted twice if the participant had both 'decreased to <60 bpm' and 'increased to >100 bpm' during post Baseline. Data for worst-case post Baseline is presented.
Time Frame Baseline (Day 1) and Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Measure Type: Count of Participants
Unit of Measure: Participants
Decrease to <60
12
  12.6%
15
  15.2%
5
  20.8%
Change to normal or no change
59
  62.1%
58
  58.6%
17
  70.8%
Increase to >100
25
  26.3%
27
  27.3%
2
   8.3%
28.Secondary Outcome
Title Number of Participants With Change From Baseline in Body Temperature
Hide Description Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with worst case change from Baseline in body temperature are presented. Data is categorized as: body temperature 'decrease to <=35 degrees celsius', 'increase to >=38 degrees celsius' and 'change to normal or no change'. If values were unchanged (example: increase to >=38 to increase to >=38 degrees celsius), or whose value became normal, were recorded in the 'change to normal or no change' category. Participants were counted twice if the participant had both 'decreased to <=35' and 'increased to >=38 degrees celsius' during post Baseline. Data for worst-case post Baseline is presented.
Time Frame Baseline (Day 1) and Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Measure Type: Count of Participants
Unit of Measure: Participants
Decrease to <=35
1
   1.1%
2
   2.0%
0
   0.0%
Change to normal or no change
86
  90.5%
86
  86.9%
21
  87.5%
Increase to >=38
8
   8.4%
10
  10.1%
3
  12.5%
29.Secondary Outcome
Title Number of Participants With Grade Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Hide Description SBP and DBP were graded using NCI CTCAE version 4.03. For SBP: Grade 0: <120 millimeter mercury (mmHg); Grade 1: 120-139 mmHg; Grade 2: 140-159 mmHg; Grade 3: >=160 mmHg. For DBP: Grade 0: <80 mmHg; Grade 1: 80-89 mmHg; Grade 2: 90-99 mmHg; Grade 3: >=100 mmHg. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case post Baseline is presented. Only those participants with increase to grade 2 and increase to grade 3 have been presented.
Time Frame Baseline (Day 1) and Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Measure Type: Count of Participants
Unit of Measure: Participants
SBP, increase to Grade 2
29
  30.5%
42
  42.4%
1
   4.2%
SBP, increase to Grade 3
13
  13.7%
19
  19.2%
6
  25.0%
DBP, increase to Grade 2
15
  15.8%
14
  14.1%
0
   0.0%
DBP, increase to Grade 3
9
   9.5%
7
   7.1%
1
   4.2%
30.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI)
Hide Description An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Number of participants who had SAEs and common (>=5%) non-SAEs are presented. Number of participants with AESI (keratopathy, dry eye events, blurred vision, thrombocytopenia, infusion-related reactions, corneal events and neutropenia) are also presented.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Measure Type: Count of Participants
Unit of Measure: Participants
Common non-SAE
93
  97.9%
96
  97.0%
24
 100.0%
SAE
38
  40.0%
47
  47.5%
15
  62.5%
Keratopathy
67
  70.5%
74
  74.7%
22
  91.7%
Dry eye events
13
  13.7%
23
  23.2%
6
  25.0%
Blurred vision
21
  22.1%
30
  30.3%
7
  29.2%
Thrombocytopenia
33
  34.7%
58
  58.6%
10
  41.7%
Infusion-related reactions
20
  21.1%
16
  16.2%
3
  12.5%
Corneal events
67
  70.5%
76
  76.8%
22
  91.7%
Neutropenia
13
  13.7%
27
  27.3%
2
   8.3%
31.Secondary Outcome
Title Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores
Hide Description Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. BCVA score was assessed individually for each eye. BCVA test scores were categorized as no change/improved vision, possible worsened vision and definite worsened vision. No change/improved vision was defined as a change from Baseline <0.12 Logarithm of the Minimum Angle of Resolution (logMAR) score; a possible worsened vision was defined as a change from Baseline >=0.12 to <0.3 logMAR score; a definite worsened vision was defined as a change from Baseline >=0.3 logMAR score. Data for worst-case change from Baseline is presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Time Frame Baseline (Day 1) and Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Measure Type: Count of Participants
Unit of Measure: Participants
Left eye, no change/improved vision, n=88,94,24 Number Analyzed 88 participants 94 participants 24 participants
38
  43.2%
46
  48.9%
6
  25.0%
Left eye, possible worsened vision, n=88,94,24 Number Analyzed 88 participants 94 participants 24 participants
12
  13.6%
16
  17.0%
3
  12.5%
Left eye, definite worsened vision, n=88,94,24 Number Analyzed 88 participants 94 participants 24 participants
38
  43.2%
32
  34.0%
15
  62.5%
Right eye, no change/improved vision, n=87,93,23 Number Analyzed 87 participants 93 participants 23 participants
34
  39.1%
39
  41.9%
5
  21.7%
Right eye, possible worsened vision, n=87,93,23 Number Analyzed 87 participants 93 participants 23 participants
24
  27.6%
18
  19.4%
8
  34.8%
Right eye, definite worsened vision, n=87,93,23 Number Analyzed 87 participants 93 participants 23 participants
29
  33.3%
36
  38.7%
10
  43.5%
32.Secondary Outcome
Title Number of Participants With Intraocular Pressure (IOP) >=22 mmHg Anytime Post-Baseline
Hide Description Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. IOP was assessed individually for each eye. Number of participants with IOP >=22 mmHg anytime post-Baseline are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Measure Type: Count of Participants
Unit of Measure: Participants
Right eye, n=88,93,23 Number Analyzed 88 participants 93 participants 23 participants
14
  15.9%
13
  14.0%
8
  34.8%
Left eye, n=88,92,24 Number Analyzed 88 participants 92 participants 24 participants
12
  13.6%
12
  13.0%
7
  29.2%
33.Secondary Outcome
Title Number of Participants With Shift in Pupillary Examination Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline)
Hide Description Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with shift in pupillary examination findings from normal (Baseline) to abnormal (worst post-Baseline) are presented.
Time Frame Baseline and Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 91 90 23
Measure Type: Count of Participants
Unit of Measure: Participants
4
   4.4%
9
  10.0%
1
   4.3%
34.Secondary Outcome
Title Number of Participants With Shift in Extraocular Muscle Movement From Yes (Baseline) to no (Worst Post-Baseline)
Hide Description Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Extraocular muscle movement was assessed individually for each eye. Number of participants with shift in extraocular muscle movement from yes (Baseline) to no (worst post-Baseline) are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Time Frame Baseline and Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Measure Type: Count of Participants
Unit of Measure: Participants
Right eye,n=95,93,23 Number Analyzed 95 participants 93 participants 23 participants
0
   0.0%
4
   4.3%
0
   0.0%
Left eye,n=93,92,22 Number Analyzed 93 participants 92 participants 22 participants
0
   0.0%
2
   2.2%
0
   0.0%
35.Secondary Outcome
Title Number of Participants With Shift in Corneal Epithelium Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) for Corneal Epithelium (CE) and Corneal Stroma (CS)
Hide Description Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Corneal epithelium findings for CE and CS were assessed individually for each eye. Number of participants with shift in corneal epithelium findings from normal (Baseline) to abnormal (worst post-Baseline) for CE and CS are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Time Frame Baseline and Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Measure Type: Count of Participants
Unit of Measure: Participants
CE, Right eye, n=53,54,17 Number Analyzed 53 participants 54 participants 17 participants
39
  73.6%
40
  74.1%
15
  88.2%
CE, Left eye,n=55,55,15 Number Analyzed 55 participants 55 participants 15 participants
39
  70.9%
44
  80.0%
13
  86.7%
CS, Right eye,n=92,94,24 Number Analyzed 92 participants 94 participants 24 participants
5
   5.4%
4
   4.3%
1
   4.2%
CS, Left eye,n=92,89,23 Number Analyzed 92 participants 89 participants 23 participants
6
   6.5%
3
   3.4%
2
   8.7%
36.Secondary Outcome
Title Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline)
Hide Description Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Corneal epithelium findings like active edema, active opacity, corneal neovascularization (CN), corneal ulcer, epithelial microcystic edema (EME) and subepithelial were performed using a slit lamp. Number of participants with shift in corneal epithelium findings from no (Baseline) to yes (worst post-Baseline) are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Time Frame Baseline and Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Measure Type: Count of Participants
Unit of Measure: Participants
Active edema, Right eye, n=94,99,24 Number Analyzed 94 participants 99 participants 24 participants
3
   3.2%
3
   3.0%
1
   4.2%
Active edema, Left eye,n=95,99,24 Number Analyzed 95 participants 99 participants 24 participants
4
   4.2%
2
   2.0%
1
   4.2%
Active opacity, Right eye,n=93,97,24 Number Analyzed 93 participants 97 participants 24 participants
2
   2.2%
2
   2.1%
1
   4.2%
Active opacity, Left eye,n=94,95,24 Number Analyzed 94 participants 95 participants 24 participants
3
   3.2%
2
   2.1%
1
   4.2%
CN, Right eye,n=93,99,24 Number Analyzed 93 participants 99 participants 24 participants
1
   1.1%
2
   2.0%
0
   0.0%
CN, Left eye,n=93,99,23 Number Analyzed 93 participants 99 participants 23 participants
0
   0.0%
1
   1.0%
0
   0.0%
Corneal ulcer, Right eye,n=61,60,22 Number Analyzed 61 participants 60 participants 22 participants
0
   0.0%
0
   0.0%
0
   0.0%
Corneal ulcer, Left eye,n=63,61,20 Number Analyzed 63 participants 61 participants 20 participants
0
   0.0%
1
   1.6%
0
   0.0%
EME, Right eye,n=95,99,24 Number Analyzed 95 participants 99 participants 24 participants
13
  13.7%
19
  19.2%
7
  29.2%
EME, Left eye,n=95,99,23 Number Analyzed 95 participants 99 participants 23 participants
15
  15.8%
21
  21.2%
7
  30.4%
Subepithelial haze, Right eye,n=95,98,24 Number Analyzed 95 participants 98 participants 24 participants
14
  14.7%
26
  26.5%
5
  20.8%
Subepithelial haze, Left eye,n=95,97,23 Number Analyzed 95 participants 97 participants 23 participants
14
  14.7%
25
  25.8%
5
  21.7%
37.Secondary Outcome
Title Number of Participants With Shift in Tear Break-up Time From >10 Seconds (Baseline) to <=5 Seconds (Worst Post-Baseline)
Hide Description Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with shift in tear break-up time from >10 seconds (Baseline) to <=5 seconds (worst post-Baseline) are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Time Frame Baseline and Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Measure Type: Count of Participants
Unit of Measure: Participants
Left eye,n=34,30,2 Number Analyzed 34 participants 30 participants 2 participants
12
  35.3%
8
  26.7%
0
   0.0%
Right eye,n=30,31,2 Number Analyzed 30 participants 31 participants 2 participants
11
  36.7%
10
  32.3%
0
   0.0%
38.Secondary Outcome
Title Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of GSK2857916 Following IV Dose in Participants With RRMM
Hide Description Blood samples were collected at designated timepoints. Pharmacokinetic (PK) parameters of GSK2857916 were calculated using non-compartmental methods. Full Pharmacokinetic (PK) Population comprised of all participants in the Full Safety Population who had atleast 1 non-missing PK assessment.
Time Frame Cycle 1 and Cycle 3: Pre-dose, end of infusion (EOI), 2 hours and 24 hours post start of infusion (SOI) on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
Cycle 1,n=26,18,18 Number Analyzed 26 participants 18 participants 18 participants
5644
(39.6%)
6495
(54.3%)
6962
(51.4%)
Cycle 3, n=19,21,9 Number Analyzed 19 participants 21 participants 9 participants
7848
(42.7%)
9199
(45.1%)
9694
(49.9%)
39.Secondary Outcome
Title Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK2857916 Following IV Dose in Participants With RRMM
Hide Description Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Time Frame Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
Cycle 1, n=30,20,22 Number Analyzed 30 participants 20 participants 22 participants
4666
(45.7%)
5678
(40.1%)
5946
(37.2%)
Cycle 3, n=26,24,11 Number Analyzed 26 participants 24 participants 11 participants
6399
(31.6%)
6941
(34.2%)
7593
(34.5%)
40.Secondary Outcome
Title Area Under the Concentration-time Curve From Zero to Time of Last Quantifiable Concentration (AUC[0-tlast]) of GSK2857916 Following IV Dose in Participants With RRMM
Hide Description Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Time Frame Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
Cycle 1, n=32,21,22 Number Analyzed 32 participants 21 participants 22 participants
4607
(54.4%)
5567
(51.0%)
6293
(45.7%)
Cycle 3, n=28,28,11 Number Analyzed 28 participants 28 participants 11 participants
6033
(44.7%)
6084
(73.8%)
8388
(46.1%)
41.Secondary Outcome
Title Maximum Observed Concentration (Cmax) of GSK2857916 Following IV Dose in Participants With RRMM
Hide Description Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Time Frame Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Microgram per milliliter
Cycle 1, n=32,21,22 Number Analyzed 32 participants 21 participants 22 participants
42.51
(26.3%)
52.03
(19.8%)
51.32
(18.3%)
Cycle 3, n=29,28,11 Number Analyzed 29 participants 28 participants 11 participants
42.35
(25.6%)
45.5
(25.3%)
48.06
(17.1%)
42.Secondary Outcome
Title Time to Reach Maximum Observed Concentration (Tmax) of GSK2857916 Following IV Dose in Participants With RRMM
Hide Description Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Time Frame Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Median (Full Range)
Unit of Measure: Hours
Cycle 1, n=32,21,22 Number Analyzed 32 participants 21 participants 22 participants
0.780
(0.42 to 2.50)
0.700
(0.43 to 2.15)
0.750
(0.48 to 2.88)
Cycle 3, n=29,28,11 Number Analyzed 29 participants 28 participants 11 participants
0.580
(0.47 to 2.03)
0.715
(0.42 to 2.90)
0.870
(0.50 to 2.02)
43.Secondary Outcome
Title Terminal Half-life (t1/2) of GSK2857916 Following IV Dose in Participants With RRMM
Hide Description Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Time Frame Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours
Cycle 1, n=29,19,22 Number Analyzed 29 participants 19 participants 22 participants
164.4
(46.2%)
165.8
(55.0%)
196.2
(40.9%)
Cycle 3, n=26,23,11 Number Analyzed 26 participants 23 participants 11 participants
193.7
(48.4%)
214.4
(45.9%)
279.5
(40.3%)
44.Secondary Outcome
Title AUC(0-infinity) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM
Hide Description Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.
Time Frame Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
Cycle 1, n=16,10,9 Number Analyzed 16 participants 10 participants 9 participants
10268
(65.8%)
10209
(64.9%)
10170
(75.0%)
Cycle 3, n=10,11,3 Number Analyzed 10 participants 11 participants 3 participants
20526
(45.1%)
18637
(69.4%)
22782
(161.1%)
45.Secondary Outcome
Title AUC(0-tau) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM
Hide Description Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.
Time Frame Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
Cycle 1, n=29,18,19 Number Analyzed 29 participants 18 participants 19 participants
7305
(41.9%)
9566
(42.2%)
9029
(40.2%)
Cycle 3, n=23,24,11 Number Analyzed 23 participants 24 participants 11 participants
11243
(34.6%)
11646
(38.0%)
15311
(43.9%)
46.Secondary Outcome
Title AUC(0-tlast) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM
Hide Description Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.
Time Frame Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
Cycle 1, n=30,19,20 Number Analyzed 30 participants 19 participants 20 participants
7417
(58.5%)
9628
(52.8%)
9017
(55.4%)
Cycle 3, n=27,26,11 Number Analyzed 27 participants 26 participants 11 participants
10725
(59.4%)
11295
(80.0%)
17715
(61.0%)
47.Secondary Outcome
Title Cmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM
Hide Description Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.
Time Frame Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Microgram per milliliter
Cycle 1, n=30,19,20 Number Analyzed 30 participants 19 participants 20 participants
48.94
(30.0%)
61.06
(26.9%)
60.08
(18.3%)
Cycle 3, n=29,28,11 Number Analyzed 29 participants 28 participants 11 participants
49.34
(32.9%)
55.60
(26.5%)
65.07
(17.4%)
48.Secondary Outcome
Title Tmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM
Hide Description Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.
Time Frame Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Median (Full Range)
Unit of Measure: Hours
Cycle 1, n=30,19,20 Number Analyzed 30 participants 19 participants 20 participants
1.750
(0.42 to 2.50)
1.870
(0.50 to 24.50)
0.650
(0.48 to 2.17)
Cycle 3, n=29,28,11 Number Analyzed 29 participants 28 participants 11 participants
0.830
(0.47 to 46.05)
1.150
(0.42 to 2.90)
1.750
(0.50 to 2.02)
49.Secondary Outcome
Title t1/2 of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM
Hide Description Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.
Time Frame Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours
Cycle 1, n=29,17,19 Number Analyzed 29 participants 17 participants 19 participants
241.8
(49.3%)
250.8
(70.3%)
299.8
(61.0%)
Cycle 3, n=23,23,11 Number Analyzed 23 participants 23 participants 11 participants
352.4
(52.6%)
372.0
(49.6%)
557.3
(91.7%)
50.Secondary Outcome
Title AUC(0-infinity) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM
Hide Description Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Time Frame Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*nanogram per milliliter
Cycle 1, n=27,20,19 Number Analyzed 27 participants 20 participants 19 participants
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
Cycle 3, n=26,29,11 Number Analyzed 26 participants 29 participants 11 participants
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
[1]
Cys-mcMMAF was not detectable throughout the elimination phase; therefore, AUC(0-infinity) could not be estimated.
51.Secondary Outcome
Title AUC(0-tau) of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM
Hide Description Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Time Frame Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*nanogram per milliliter
Cycle 1, n=27,20,19 Number Analyzed 27 participants 20 participants 19 participants
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
Cycle 3, n=26,29,11 Number Analyzed 26 participants 29 participants 11 participants
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
[1]
Cys-mcMMAF was not detectable throughout the dosing interval; therefore, AUC(0-tau) could not be estimated.
52.Secondary Outcome
Title AUC(0-tlast) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM
Hide Description Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Time Frame Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*nanogram per milliliter
Cycle 1, n=27,20,19 Number Analyzed 27 participants 20 participants 19 participants
79.26
(61.0%)
113.57
(58.3%)
100.35
(51.8%)
Cycle 3, n=26,29,11 Number Analyzed 26 participants 29 participants 11 participants
70.84
(46.9%)
74.04
(73.0%)
69.83
(36.6%)
53.Secondary Outcome
Title Cmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM
Hide Description Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Time Frame Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram per milliliter
Cycle 1, n=27,20,19 Number Analyzed 27 participants 20 participants 19 participants
0.903
(63.9%)
1.148
(64.7%)
1.017
(61.4%)
Cycle 3, n=26,29,11 Number Analyzed 26 participants 29 participants 11 participants
0.660
(52.3%)
0.749
(66.2%)
0.656
(47.6%)
54.Secondary Outcome
Title Tmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM
Hide Description Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Time Frame Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Median (Full Range)
Unit of Measure: Hours
Cycle 1, n=27,20,19 Number Analyzed 27 participants 20 participants 19 participants
22.830
(1.92 to 65.63)
23.835
(17.38 to 72.65)
24.080
(0.97 to 69.47)
Cycle 3, n=26,29,11 Number Analyzed 26 participants 29 participants 11 participants
23.235
(0.58 to 46.08)
22.570
(0.55 to 70.98)
22.780
(0.50 to 71.93)
55.Secondary Outcome
Title t1/2 of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM
Hide Description Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Time Frame Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours
Cycle 1, n=27,20,19 Number Analyzed 27 participants 20 participants 19 participants
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
Cycle 3, n=26,29,11 Number Analyzed 26 participants 29 participants 11 participants
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
[1]
Cys-mcMMAF was not detectable throughout the elimination phase; therefore, t1/2 could not be estimated.
56.Secondary Outcome
Title Number of Participants With at Least One Confirmed Positive Post-Baseline Anti-drug Antibody (ADA) Result
Hide Description Serum samples were collected for the determination of anti-GSK2857916 antibodies (ADA) using a validated electrochemiluminescent (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 89 92 22
Measure Type: Count of Participants
Unit of Measure: Participants
2
   2.2%
0
   0.0%
0
   0.0%
57.Secondary Outcome
Title Titers of Anti-drug Antibodies Against GSK2857916
Hide Description Serum samples were collected for the determination of ADA using a validated ECL immunoassay. The assay involved screening, confirmation and titration steps. If serum samples contained ADA, they were further analyzed for the specificity of antibodies by a confirmation assay. Confirmed positive samples were titrated to obtain the titers of antibodies. Titers of anti-drug antibodies against GSK2857916 is presented. No participant was found with positive results for ADA test in arms; GSK2857916 3.4 mg/kg (Frozen liquid) and GSK2857916 3.4 mg/kg (Lyophilized). Hence, titer values are not presented for both these arms.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 2 0 0
Mean (Standard Deviation)
Unit of Measure: Titers
100  (0)
58.Secondary Outcome
Title Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Hide Description The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. It included symptomatic toxicities drawn from the CTCAE like blurred vision (BV), chills, constipation, decreased appetite (DA), fatigue, general pain (GP), heart palpitations (HP), mouth/throat (M/T) sores, nausea, nosebleed, shortness of breath (SB), vomiting and watery eyes (WE). Items were scored individually on a 0 to 4 scale for severity, frequency and interference. Number of participants with symptomatic AEs (those who had a maximum post-Baseline rating greater than 0, example; 1, 2, 3, or 4) measured by PRO-CTCAE are presented.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 95 99 24
Measure Type: Count of Participants
Unit of Measure: Participants
BV
58
  61.1%
63
  63.6%
18
  75.0%
Chills
38
  40.0%
33
  33.3%
11
  45.8%
Constipation
39
  41.1%
43
  43.4%
15
  62.5%
DA
59
  62.1%
61
  61.6%
16
  66.7%
Fatigue
80
  84.2%
85
  85.9%
21
  87.5%
GP
76
  80.0%
77
  77.8%
19
  79.2%
HP
31
  32.6%
28
  28.3%
12
  50.0%
M/T sores
24
  25.3%
21
  21.2%
7
  29.2%
Nausea
42
  44.2%
45
  45.5%
11
  45.8%
Nosebleed
16
  16.8%
32
  32.3%
4
  16.7%
SB
57
  60.0%
52
  52.5%
16
  66.7%
Vomiting
15
  15.8%
23
  23.2%
4
  16.7%
WE
48
  50.5%
53
  53.5%
18
  75.0%
59.Secondary Outcome
Title Worst Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Score
Hide Description The NEI-VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question to assess the impact of ocular toxicity on visual function. Items were coded to a 0 to 100 scale and averaged to calculate domains. Domain scores ranged from 0 to 100; higher scores are better. Therefore, increase in score means improvement. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for worst-case post Baseline is presented.
Time Frame Baseline (Day 1) and up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 82 90 22
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-18.8  (22.00) -17.6  (21.13) -21.4  (23.71)
60.Secondary Outcome
Title Worst Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score
Hide Description The OSDI is a 12-item questionnaire designed to assess both the frequency of dry eye symptoms and their impact on vision-related functioning. The total OSDI score was calculated as (sum of scores for all questions answered*100) divided by (total number of questions answered*4). Domain scores ranged from 0 to 100; lower scores are better. Therefore, decrease in score from Baseline means improvement. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for worst-case post Baseline is presented.
Time Frame Baseline (Day 1) and up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 82 91 22
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
25.4  (28.99) 25.1  (28.10) 34.3  (29.57)
61.Secondary Outcome
Title Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Hide Description The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included five functional scales (physical functioning [PF], role functioning [RF], cognitive functioning [CF], emotional functioning [EF] and social functioning [SF]), three symptom scales (fatigue, pain and nausea/vomiting [N/V]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhea, insomnia, dyspnea, appetite loss [AL] and financial difficulties [FD]). Response options are 1 to 4. Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time Frame Baseline (Day 1) and Week 07, Week 13, Week 19, Week 25, Week 31, Week 37 and Week 43
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2857916 2.5 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Frozen Liquid) GSK2857916 3.4 mg/kg (Lyophilized)
Hide Arm/Group Description:
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 11 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of 10 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 8 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
Overall Number of Participants Analyzed 46 46 17
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
GHS/QoL,Week 07,n=46,46,17 Number Analyzed 46 participants 46 participants 17 participants
0.4  (20.18) -4.7  (18.23) 1.5  (23.80)
GHS/QoL,Week 13,n=29,28,16 Number Analyzed 29 participants 28 participants 16 participants
-3.2  (18.42) 5.7  (16.36) 1.0  (14.23)
GHS/QoL,Week 19,n=19,26,10 Number Analyzed 19 participants 26 participants 10 participants
-2.2  (13.84) 1.9  (18.30) -0.0  (12.42)
GHS/QoL,Week 25,n=19,23,4 Number Analyzed 19 participants 23 participants 4 participants
-4.4  (16.52) -2.5  (20.94) 8.3  (11.79)
GHS/QoL,Week 31,n=12,14,0 Number Analyzed 12 participants 14 participants 0 participants
-2.1  (12.37) 8.9  (17.13)
GHS/QoL,Week 37,n=4,3,0 Number Analyzed 4 participants 3 participants 0 participants
-2.1  (4.17) 11.1  (12.73)
GHS/QoL,Week 43,n=0,2,0 Number Analyzed 0 participants 2 participants 0 participants
25.0  (0.00)
PF,Week 07,n=46,46,17 Number Analyzed 46 participants 46 participants 17 participants
5.1  (15.34) -1.6  (21.78) -5.5  (24.18)
PF,Week 13,n=29,28,16 Number Analyzed 29 participants 28 participants 16 participants
0.7  (14.62) 6.4  (15.02) -12.5  (23.84)
PF,Week 19,n=19,26,10 Number Analyzed 19 participants 26 participants 10 participants
0.4  (13.78) 4.9  (24.77) -4.0  (14.81)
PF,Week 25,n=19,23,4 Number Analyzed 19 participants 23 participants 4 participants
1.8  (12.34) 5.5  (25.08) 3.3  (12.77)
PF,Week 31,n=12,14,0 Number Analyzed 12 participants 14 participants 0 participants
-1.1  (8.45) 9.0  (18.42)
PF,Week 37,n=4,3,0 Number Analyzed 4 participants 3 participants 0 participants
6.7  (9.43) 22.2  (34.21)
PF,Week 43,n=0,2,0 Number Analyzed 0 participants 2 participants 0 participants
43.3  (23.57)
RF,Week 07,n=46,46,17 Number Analyzed 46 participants 46 participants 17 participants
0.7  (33.88) -8.3  (32.35) -7.8  (25.08)
RF,Week 13,n=29,28,16 Number Analyzed 29 participants 28 participants 16 participants
2.3  (33.55) -0.6  (33.48) -6.3  (30.96)
RF,Week 19,n=19,26,10 Number Analyzed 19 participants 26 participants 10 participants
-4.4  (31.35) -3.2  (30.56) -5.0  (23.64)
RF,Week 25,n=19,23,4 Number Analyzed 19 participants 23 participants 4 participants
2.6  (33.45) 0.0  (32.57) 0.0  (36.00)
RF,Week 31,n=12,14,0 Number Analyzed 12 participants 14 participants 0 participants
13.9  (22.29) 1.2  (32.99)
RF,Week 37,n=4,3,0 Number Analyzed 4 participants 3 participants 0 participants
4.2  (8.33) 27.8  (34.69)
RF,Week 43,n=0,2,0 Number Analyzed 0 participants 2 participants 0 participants
33.3  (47.14)
EF,Week 07,n=46,46,17 Number Analyzed 46 participants 46 participants 17 participants
1.8  (19.08) 1.1  (27.31) -4.4  (21.27)
EF,Week 13,n=29,28,16 Number Analyzed 29 participants 28 participants 16 participants
-2.0  (23.00) 2.4  (28.41) -9.4  (23.35)
EF,Week 19,n=19,26,10 Number Analyzed 19 participants 26 participants 10 participants
0.4  (19.93) 1.9  (20.59) -1.7  (21.08)
EF,Week 25,n=19,23,4 Number Analyzed 19 participants 23 participants 4 participants
-4.8  (21.75) 4.0  (20.39) 0.0  (18.00)
EF,Week 31,n=12,14,0 Number Analyzed 12 participants 14 participants 0 participants
2.1  (21.94) 4.2  (26.70)
EF,Week 37,n=4,3,0 Number Analyzed 4 participants 3 participants 0 participants
4.2  (8.33) 25.0  (36.32)
EF,Week 43,n=0,2,0 Number Analyzed 0 participants 2 participants 0 participants
45.8  (41.25)
CF,Week 07,n=46,46,17 Number Analyzed 46 participants 46 participants 17 participants
4.7  (20.98) -2.2  (21.26) -1.0  (20.81)
CF,Week 13,n=29,28,16 Number Analyzed 29 participants 28 participants 16 participants
2.3  (23.45) -0.6  (16.03) -15.6  (27.53)
CF,Week 19,n=19,26,10 Number Analyzed 19 participants 26 participants 10 participants
-1.8  (26.58) -0.6  (23.32) -6.7  (21.08)
CF,Week 25,n=19,23,4 Number Analyzed 19 participants 23 participants 4 participants
-1.8  (28.27) 1.4  (21.27) -4.2  (20.97)
CF,Week 31,n=12,14,0 Number Analyzed 12 participants 14 participants 0 participants
9.7  (25.08) -0.0  (18.49)
CF,Week 37,n=4,3,0 Number Analyzed 4 participants 3 participants 0 participants
8.3  (28.87) 11.1  (19.25)
CF,Week 43,n=0,2,0 Number Analyzed 0 participants 2 participants 0 participants
16.7  (23.57)
SF,Week 07,n=46,46,17 Number Analyzed 46 participants 46 participants 17 participants
4.7  (29.12) 0.7  (32.76) -1.0  (33.58)
SF,Week 13,n=29,28,16 Number Analyzed 29 participants 28 participants 16 participants
-4.0  (28.75) 3.6  (31.54) -7.3  (31.01)
SF,Week 19,n=19,26,10 Number Analyzed 19 participants 26 participants 10 participants
-6.1  (28.44) 4.5  (28.50) -6.7  (28.54)
SF,Week 25,n=19,23,4 Number Analyzed 19 participants 23 participants 4 participants
-7.9  (26.86) 13.8  (22.84) -0.0  (36.00)
SF,Week 31,n=12,14,0 Number Analyzed 12 participants 14 participants 0 participants
2.8  (13.91)