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Trial record 99 of 108 for:    CALCIUM CATION

Study to Evaluate GSK3052230 in Combination With Paclitaxel and Carboplatin, or Docetaxel or as Single Agent in Subjects With Solid Malignancies and Deregulated Fibroblast Growth Factor (FGF) Pathway Signaling

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ClinicalTrials.gov Identifier: NCT01868022
Recruitment Status : Completed
First Posted : June 4, 2013
Results First Posted : February 11, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neoplasms
Interventions Drug: GSK3052230
Drug: paclitaxel
Drug: carboplatin
Drug: docetaxel
Drug: pemetrexed
Drug: cisplatin
Enrollment 65
Recruitment Details This was a non-randomized, parallel-group study in participants (par.) with Solid Malignancies and Deregulated Fibroblast growth factor (FGF) Pathway Signaling. Participants administered GSK3052230 in combination with paclitaxel + carboplatin (Arm A) or in combination with docetaxel (Arm B) or in combination with pemetrexed + cisplatin (Arm C).
Pre-assignment Details Total 65 participants were enrolled in 3 Arms. In Arm A 20 participants were enrolled across 3 cohorts, Arm B 9 participants were enrolled across 3 cohorts, Arm C 36 participants were enrolled across 3 cohorts.The study was conducted at 22 centers across 7 countries from 9-Oct-2013 to 24-Oct-2017.
Arm/Group Title 5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Hide Arm/Group Description Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Period Title: Overall Study
Started 3 3 14 3 3 3 3 25 8
Completed 3 3 13 2 1 2 3 16 6
Not Completed 0 0 1 1 2 1 0 9 2
Reason Not Completed
Withdrawal by Subject             0             0             1             1             0             0             0             1             0
Adverse Event             0             0             0             0             2             0             0             2             2
Physician Decision             0             0             0             0             0             1             0             2             0
Study closed/terminated             0             0             0             0             0             0             0             1             0
Ongoing             0             0             0             0             0             0             0             3             0
Arm/Group Title 5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C Total
Hide Arm/Group Description Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin Total of all reporting groups
Overall Number of Baseline Participants 3 3 14 3 3 3 3 25 8 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 14 participants 3 participants 3 participants 3 participants 3 participants 25 participants 8 participants 65 participants
71.0  (5.29) 71.7  (5.03) 65.0  (7.55) 58.0  (8.19) 67.0  (12.00) 65.7  (5.77) 72.3  (7.51) 57.1  (13.90) 70.9  (6.06) 66.52  (3.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 14 participants 3 participants 3 participants 3 participants 3 participants 25 participants 8 participants 65 participants
Female
0
   0.0%
0
   0.0%
1
   7.1%
0
   0.0%
0
   0.0%
1
  33.3%
1
  33.3%
8
  32.0%
2
  25.0%
13
  20.0%
Male
3
 100.0%
3
 100.0%
13
  92.9%
3
 100.0%
3
 100.0%
2
  66.7%
2
  66.7%
17
  68.0%
6
  75.0%
52
  80.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 14 participants 3 participants 3 participants 3 participants 3 participants 25 participants 8 participants 65 participants
White - Arabic/North African Heritage
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.5%
White - White/Caucasian/European Heritage
2
  66.7%
3
 100.0%
14
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
24
  96.0%
8
 100.0%
63
  96.9%
Asian - Central/South Asian Heritage
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.0%
0
   0.0%
1
   1.5%
1.Primary Outcome
Title Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)
Hide Description An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, protocol-specific events including drug-induced liver injury with hyperbilirubinaemia, any new primary cancers, cardiac toxicity including Left Ventricular Ejection Fraction (LVEF) changes or treatment emergent cardiac valve toxicity and treatment emergent acute anterior uveitis were categorized as SAE. Participants having non-serious AE or SAE were included in the analysis. The All Treated Subjects Population comprised of all participants who received at least one dose of study treatment.
Time Frame Median of 28.5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Subjects Population
Arm/Group Title 5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Hide Arm/Group Description:
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Overall Number of Participants Analyzed 3 3 14 3 3 3 3 25 8
Measure Type: Count of Participants
Unit of Measure: Participants
Non-serious AEs
3
 100.0%
3
 100.0%
14
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
24
  96.0%
8
 100.0%
SAEs
0
   0.0%
3
 100.0%
5
  35.7%
2
  66.7%
3
 100.0%
1
  33.3%
0
   0.0%
5
  20.0%
4
  50.0%
2.Primary Outcome
Title Number of Participants With Severe AEs and SAEs
Hide Description The severity of AEs were graded utilizing National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.3. Grade 1 represents mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 represents moderate; minimal, local or noninvasive intervention indicated. Grade 3 represents severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4 represents life-threatening consequences; urgent intervention indicated. Grade 5 represents death related to AE.
Time Frame Median of 28.5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Subjects Population
Arm/Group Title 5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Hide Arm/Group Description:
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Overall Number of Participants Analyzed 3 3 14 3 3 3 3 25 8
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.0%
0
   0.0%
Grade 2
0
   0.0%
0
   0.0%
2
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
2
  66.7%
7
  28.0%
1
  12.5%
Grade 3
1
  33.3%
1
  33.3%
8
  57.1%
2
  66.7%
2
  66.7%
0
   0.0%
1
  33.3%
17
  68.0%
4
  50.0%
Grade 4
2
  66.7%
2
  66.7%
4
  28.6%
1
  33.3%
1
  33.3%
3
 100.0%
0
   0.0%
0
   0.0%
2
  25.0%
Grade 5
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
3.Primary Outcome
Title Number of Participants Withdrew Due to AEs
Hide Description An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. The AEs leading to permanent discontinuation from the study has been reported.
Time Frame Median of 28.5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Subjects Population
Arm/Group Title 5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Hide Arm/Group Description:
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Overall Number of Participants Analyzed 3 3 14 3 3 3 3 25 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
2
  66.7%
1
   4.0%
3
  37.5%
4.Primary Outcome
Title Number of Participants With Dose Reduction
Hide Description Dose reduction and delays were done due to toxicity, or in the interest of participant’s safety per investigator discretion. Requirement for more than 2 dose reductions resulted in permanent discontinuation of chemotherapy. Participants with dose reduction has been reported.
Time Frame Median of 28.5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Subjects Population
Arm/Group Title 5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Hide Arm/Group Description:
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Overall Number of Participants Analyzed 3 3 14 3 3 3 3 25 8
Measure Type: Count of Participants
Unit of Measure: Participants
1
  33.3%
0
   0.0%
3
  21.4%
1
  33.3%
0
   0.0%
2
  66.7%
0
   0.0%
2
   8.0%
0
   0.0%
5.Primary Outcome
Title Number of Participants With Dose Delays
Hide Description Dose reduction and delays were done due to toxicity, or in the interest of participant’s safety per investigator discretion. Requirement for more than 2 dose reductions resulted in permanent discontinuation of chemotherapy. Participants with dose delay has been reported.
Time Frame Median of 28.5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Subjects Population
Arm/Group Title 5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Hide Arm/Group Description:
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Overall Number of Participants Analyzed 3 3 14 3 3 3 3 25 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2
  66.7%
4
  28.6%
2
  66.7%
1
  33.3%
0
   0.0%
2
  66.7%
12
  48.0%
1
  12.5%
6.Primary Outcome
Title Treatment Duration With GSK3052230
Hide Description The number of participants administered study treatment were summarized according to the duration of therapy. The extent of treatment exposure is calculated as the number of cycles administered. The duration of exposure to study treatment is calculated from first day to last day of treatment plus 1 day. Median and full range (minimum and maximum) has been reported.
Time Frame Median of 28.5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Subjects Population
Arm/Group Title 5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Hide Arm/Group Description:
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Overall Number of Participants Analyzed 3 3 14 3 3 3 3 25 8
Median (Full Range)
Unit of Measure: Cycles
7.0
(3 to 8)
15.0
(5 to 20)
8.0
(2 to 13)
6.0
(2 to 7)
4.0
(2 to 14)
6.0
(3 to 8)
6.0
(4 to 8)
11.0
(1 to 23)
3.0
(1 to 32)
7.Primary Outcome
Title Number of Participants With Dose-Limiting Toxicities (DLT)
Hide Description DLT is defined as toxicities due to GSK3052230 or due to the combination of GSK3052230 with chemotherapy within Cycle 1 (first 21 days of period on study) that are unlikely to be due to another cause, such as the known effects of cytotoxics chemotherapy alone, disease progression, or accident, and protocol-specified criteria. Clinically significant toxicities that persist or occur beyond Cycle 1 that the investigator and GlaxoSmithKline (GSK) medical monitor consider dose-limiting may also be designated a DLT for the purpose of establishing Maximum tolerated dose (MTD). Number of participants with DLTs has been reported.
Time Frame Median of 28.5 weeks
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All Treated Subjects Population
Arm/Group Title 5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Hide Arm/Group Description:
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Overall Number of Participants Analyzed 3 3 14 3 3 3 3 25 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.0%
3
  37.5%
8.Primary Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Hide Description Blood pressure was measured in a semi-supine position after 5 minutes of rest. Blood pressure was measured before start of first chemotherapy infusion and within 20 minutes before start of GSK3052230 infusion on Day 1 of every cycle and Baseline. Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. The worst-case post-Baseline values has been presented. NA indicates that data were not available as standard deviation could not be calculated for a single participant. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Baseline and up to Median of 28.5 weeks
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All Treated Subjects Population
Arm/Group Title 5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Hide Arm/Group Description:
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Overall Number of Participants Analyzed 3 3 14 3 3 3 3 25 8
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mmHg)
DBP, n=3, 2, 9, 3, 2, 2, 3, 21, 5 Number Analyzed 3 participants 2 participants 9 participants 3 participants 2 participants 2 participants 3 participants 21 participants 5 participants
6.3  (16.17) 0.5  (12.02) 2.0  (10.39) -0.6  (3.06) 6.0  (2.83) 3.5  (9.19) 2.3  (7.64) 12.8  (8.38) 10.6  (2.30)
SBP, n=3, 1, 13, 2, 2, 2, 3, 21, 4 Number Analyzed 3 participants 1 participants 13 participants 2 participants 2 participants 2 participants 3 participants 21 participants 4 participants
-12.3  (15.31) -14.0 [1]   (NA) 9.6  (10.16) 10.5  (14.85) 17.5  (3.54) 6.0  (22.63) 3.0  (13.00) 12.5  (13.21) 18.7  (15.97)
[1]
NA indicates that data were not available as standard deviation could not be calculated for a single participant.
9.Primary Outcome
Title Change From Baseline in Heart Rate
Hide Description Heart rate was measured in a semi-supine position after 5 minutes of rest. Heart rate was measured before start of first chemotherapy infusion and within 20 minutes before start of GSK3052230 infusion on Day 1 of every cycle and Baseline. Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. The worst-case post-Baseline values has been presented.
Time Frame Baseline and up to Median of 28.5 weeks
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Hide Analysis Population Description
All Treated Subjects Population. Number of par. analyzed > number of par. started in the study, as these were bi-directional vital signs tests. Heart rate had both clinically significant low and high ranges and there were par. who experienced both worst case post-Baseline values.Only those par. available at the specified time points were analyzed.
Arm/Group Title 5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Hide Arm/Group Description:
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Overall Number of Participants Analyzed 3 3 14 3 3 3 3 25 7
Overall Number of Units Analyzed
Type of Units Analyzed: Heart rate readings
3 4 17 3 4 3 3 26 7
Mean (Standard Deviation)
Unit of Measure: Beats per minute (bpm)
-0.3  (15.31) 3.2  (24.74) 8.0  (23.67) 28.0  (42.79) 10.5  (19.33) 0.6  (3.06) -5.0  (1.73) 2.8  (20.49) 24.4  (21.56)
10.Primary Outcome
Title Change From Baseline in Temperature
Hide Description Temperature was measured in a semi-supine position after 5 minutes of rest. Temperature was measured before start of first chemotherapy infusion and within 20 minutes before start of GSK3052230 infusion on Day 1 of every cycle and Baseline. Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. The worst-case post-Baseline values has been presented.
Time Frame Baseline and up to Median of 28.5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Subjects Population. Number of par. analyzed > number of par. started in the study, as these were bi-directional vital signs tests. Heart rate had both clinically significant low and high ranges and there were par. who experienced both worst case post-Baseline values.Only those par. available at the specified time points were analyzed.
Arm/Group Title 5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Hide Arm/Group Description:
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Overall Number of Participants Analyzed 3 3 14 2 3 3 3 25 8
Overall Number of Units Analyzed
Type of Units Analyzed: Temperature readings
3 4 14 2 3 3 3 27 8
Mean (Standard Deviation)
Unit of Measure: Degree Celsius
-0.30  (0.361) -0.38  (0.608) 0.35  (0.917) 0.10  (0.283) 1.03  (1.795) -0.03  (0.058) -0.23  (0.208) -0.16  (0.899) 0.12  (0.742)
11.Primary Outcome
Title Number of Participants With Clinically Significant Findings for 12-lead Electrocardiogram (ECG)
Hide Description A single 12-lead ECG was performed at the specified timepoints during the study where the participant was instructed to be in semi-recumbent position for 5 minutes before obtaining the ECG. An ECG machine that automatically calculated the heart rate and measures like the PR, QRS, QT, and corrected QT intervals. Number of participants with worst-case post-Baseline abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported.
Time Frame Median of 28.5 weeks
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All Treated Subjects Population
Arm/Group Title 5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Hide Arm/Group Description:
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Overall Number of Participants Analyzed 3 3 14 3 3 3 3 25 8
Measure Type: Count of Participants
Unit of Measure: Participants
Abnormal not clinically significant
0
   0.0%
2
  66.7%
8
  57.1%
2
  66.7%
2
  66.7%
3
 100.0%
1
  33.3%
12
  48.0%
2
  25.0%
Abnormal clinically significant
0
   0.0%
0
   0.0%
1
   7.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
  12.0%
3
  37.5%
12.Primary Outcome
Title Number of Participants With Abnormal Echocardiogram (ECHO) Findings
Hide Description Echocardiography scans were obtained at given time points using an echocardiogram and the findings for left ventricular ejection fraction (LVEF) were obtained. LVEF values at end of treatment (EOT) were recorded as no change or any increase and any decrease values. Only those participants available at the specified time points were analyzed.
Time Frame Median of 28.5 weeks
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Hide Analysis Population Description
All Treated Subjects Population
Arm/Group Title 5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Hide Arm/Group Description:
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Overall Number of Participants Analyzed 1 0 2 1 0 2 0 5 2
Measure Type: Count of Participants
Unit of Measure: Participants
No change or any increase
0
   0.0%
1
  50.0%
0
   0.0%
1
  50.0%
2
  40.0%
2
 100.0%
Any Decrease
1
 100.0%
1
  50.0%
1
 100.0%
1
  50.0%
3
  60.0%
0
   0.0%
13.Primary Outcome
Title Number of Participants With Clinical Chemistry Changes From Baseline With Respect to the Normal Range
Hide Description Clinical chemistry parameters included potassium, sodium, chloride (Cl), total carbon dioxide (CO2), total and ionized calcium, magnesium, phosphate, albumin, glucose (fasting), Blood urea nitrogen (BUN), creatinine (Cr), uric acid, creatinine clearance, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transferase (GGT), alkaline phosphatase, Total bilirubin (T. Bil), and Direct bilirubin (D. Bil), total T3 and T4, free T4, amylase, lipase, prothrombin time, partial thromboplastin time, international normalized ratio, and fibrinogen. Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. Clinical chemistry parameters with change from Baseline with respect to normal range only has been presented. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Median of 28.5 weeks
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Hide Analysis Population Description
All Treated Subjects Population
Arm/Group Title 5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Hide Arm/Group Description:
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Overall Number of Participants Analyzed 3 3 14 3 3 3 3 25 8
Measure Type: Count of Participants
Unit of Measure: Participants
D.Bil, decrease to low, n=2,2,8,1,2,2,1,12,6 Number Analyzed 2 participants 2 participants 8 participants 1 participants 2 participants 2 participants 1 participants 12 participants 6 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
D.Bil, normal or no change, n=2,2,8,1,2,2,1,12,6 Number Analyzed 2 participants 2 participants 8 participants 1 participants 2 participants 2 participants 1 participants 12 participants 6 participants
2
 100.0%
1
  50.0%
7
  87.5%
1
 100.0%
2
 100.0%
1
  50.0%
1
 100.0%
7
  58.3%
5
  83.3%
D.Bil, increase to high, n=2,2,8,1,2,2,1,12,6 Number Analyzed 2 participants 2 participants 8 participants 1 participants 2 participants 2 participants 1 participants 12 participants 6 participants
0
   0.0%
1
  50.0%
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5
  41.7%
1
  16.7%
Cl, decrease to low, n=3,3,14,3,3,3,3,25,8 Number Analyzed 3 participants 3 participants 14 participants 3 participants 3 participants 3 participants 3 participants 25 participants 8 participants
1
  33.3%
1
  33.3%
5
  35.7%
0
   0.0%
2
  66.7%
1
  33.3%
2
  66.7%
9
  36.0%
3
  37.5%
Cl, normal or no change, n=3,3,14,3,3,3,3,25,8 Number Analyzed 3 participants 3 participants 14 participants 3 participants 3 participants 3 participants 3 participants 25 participants 8 participants
2
  66.7%
0
   0.0%
8
  57.1%
3
 100.0%
1
  33.3%
2
  66.7%
1
  33.3%
15
  60.0%
5
  62.5%
Cl, increase to high, n=3,3,14,3,3,3,3,25,8 Number Analyzed 3 participants 3 participants 14 participants 3 participants 3 participants 3 participants 3 participants 25 participants 8 participants
0
   0.0%
2
  66.7%
1
   7.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   8.0%
2
  25.0%
CO2, decrease to low, n=3,3,14,3,3,3,3,25,8 Number Analyzed 3 participants 3 participants 14 participants 3 participants 3 participants 3 participants 3 participants 25 participants 8 participants
0
   0.0%
1
  33.3%
3
  21.4%
1
  33.3%
0
   0.0%
0
   0.0%
1
  33.3%
2
   8.0%
0
   0.0%
CO2, normal or no change, n=3,3,14,3,3,3,3,25,8 Number Analyzed 3 participants 3 participants 14 participants 3 participants 3 participants 3 participants 3 participants 25 participants 8 participants
2
  66.7%
1
  33.3%
8
  57.1%
2
  66.7%
3
 100.0%
1
  33.3%
2
  66.7%
17
  68.0%
5
  62.5%
CO2, increase to high, n=3,3,14,3,3,3,3,25,8 Number Analyzed 3 participants 3 participants 14 participants 3 participants 3 participants 3 participants 3 participants 25 participants 8 participants
1
  33.3%
2
  66.7%
6
  42.9%
0
   0.0%
0
   0.0%
2
  66.7%
0
   0.0%
7
  28.0%
3
  37.5%
Cr CL, decrease to low, n=3,3,9,2,1,3,3,15,4 Number Analyzed 3 participants 3 participants 9 participants 2 participants 1 participants 3 participants 3 participants 15 participants 4 participants
1
  33.3%
2
  66.7%
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
9
  60.0%
0
   0.0%
Cr CL, normal or no change, n=3,3,9,2,1,3,3,15,4 Number Analyzed 3 participants 3 participants 9 participants 2 participants 1 participants 3 participants 3 participants 15 participants 4 participants
2
  66.7%
1
  33.3%
8
  88.9%
1
  50.0%
1
 100.0%
3
 100.0%
2
  66.7%
6
  40.0%
4
 100.0%
Cr CL, increase to high, n=3,3,9,2,1,3,3,15,4 Number Analyzed 3 participants 3 participants 9 participants 2 participants 1 participants 3 participants 3 participants 15 participants 4 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
T4 free, decrease to low, n=0,1,6,0,1,0,2,16,3 Number Analyzed 0 participants 1 participants 6 participants 0 participants 1 participants 0 participants 2 participants 16 participants 3 participants
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
1
   6.3%
1
  33.3%
T4 free, normal or no change,=0,1,6,0,1,0,2,16,3 Number Analyzed 0 participants 1 participants 6 participants 0 participants 1 participants 0 participants 2 participants 16 participants 3 participants
1
 100.0%
5
  83.3%
1
 100.0%
2
 100.0%
12
  75.0%
2
  66.7%
T4 free, increase to high, n=0,1,6,0,1,0,2,16,3 Number Analyzed 0 participants 1 participants 6 participants 0 participants 1 participants 0 participants 2 participants 16 participants 3 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
  18.8%
0
   0.0%
T4 total, decrease to low, n=0,0,0,0,0,0,1,4,1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 4 participants 1 participants
0
   0.0%
1
  25.0%
0
   0.0%
T4 total, normal or no change, n=0,0,0,0,0,0,1,4,1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 4 participants 1 participants
1
 100.0%
1
  25.0%
0
   0.0%
T4 total, increase to high, n=0,0,0,0,0,0,1,4,1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 4 participants 1 participants
0
   0.0%
2
  50.0%
1
 100.0%
Total T3, decrease to low, n=0,1,1,0,1,0,1,6,3 Number Analyzed 0 participants 1 participants 1 participants 0 participants 1 participants 0 participants 1 participants 6 participants 3 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
  50.0%
2
  66.7%
Total T3, normal or no change, n=0,1,1,0,1,0,1,6,3 Number Analyzed 0 participants 1 participants 1 participants 0 participants 1 participants 0 participants 1 participants 6 participants 3 participants
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
2
  33.3%
1
  33.3%
Total T3, increase to high, n=0,1,1,0,1,0,1,6,3 Number Analyzed 0 participants 1 participants 1 participants 0 participants 1 participants 0 participants 1 participants 6 participants 3 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
Urea/BUN, decrease to low, n=3,2,13,3,2,3,3,25,8 Number Analyzed 3 participants 2 participants 13 participants 3 participants 2 participants 3 participants 3 participants 25 participants 8 participants
1
  33.3%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
4
  16.0%
1
  12.5%
Urea/BUN,normal or no change,n=3,2,13,3,2,3,3,25,8 Number Analyzed 3 participants 2 participants 13 participants 3 participants 2 participants 3 participants 3 participants 25 participants 8 participants
2
  66.7%
2
 100.0%
8
  61.5%
1
  33.3%
2
 100.0%
2
  66.7%
1
  33.3%
11
  44.0%
3
  37.5%
Urea/BUN, increase to high, n=3,2,13,3,2,3,3,25,8 Number Analyzed 3 participants 2 participants 13 participants 3 participants 2 participants 3 participants 3 participants 25 participants 8 participants
0
   0.0%
0
   0.0%
5
  38.5%
1
  33.3%
0
   0.0%
1
  33.3%
2
  66.7%
10
  40.0%
4
  50.0%
14.Primary Outcome
Title Number of Participants With the Abnormal Urinalysis Findings
Hide Description Urinalysis parameters included urine protein, urine glucose, urine ketones and occult blood were assessed. Dipstick test was performed for routine urinalysis. Abnormal values such as trace, 1+, 2+, 3+, 4+, >1000, >=1000, and >10 have been reported.
Time Frame Up to Cycle 16 (each cycle was of 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Subjects Population
Arm/Group Title 5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Hide Arm/Group Description:
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Overall Number of Participants Analyzed 3 3 14 3 3 3 3 25 8
Measure Type: Count of Participants
Unit of Measure: Participants
Cycle 1 Day 1, Urine glucose, >1000
0
   0.0%
0
   0.0%
1
   7.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Cycle 1 Day 1, Urine glucose, 2+
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Cycle 1 Day 1, Urine glucose, trace
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
Cycle 2 Day 1, Urine glucose, trace
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
Cycle 4 Day 1, Urine glucose, >=1000
0
   0.0%
0
   0.0%
1
   7.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Cycle 4 Day 1, Urine glucose, 4+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
Cycle 1 Day 1, Urine ketones, trace
0
   0.0%
0
   0.0%
1
   7.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.0%
2
  25.0%
Cycle 4 Day 1, Urine ketones, trace
0
   0.0%
0
   0.0%
1
   7.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Cycle 28, Day 1, Urine ketones, trace
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
Cycle 1 Day 1, Occult Blood, 1+
0
   0.0%
0
   0.0%
2
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
Cycle 1 Day 1, Occult Blood, 3+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.0%
0
   0.0%
Cycle 2 Day 1, Occult Blood, 1+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.0%
1
  12.5%
Cycle 2 Day 1, Occult Blood, trace
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
Cycle 4 Day 1, Occult Blood, trace
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
Cycle 4 Day 1, Occult Blood, 1+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Cycle 4 Day 1, Occult Blood, 2+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.0%
0
   0.0%
Cycle 8 Day 1, Occult Blood, 1+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.0%
0
   0.0%
Cycle 1 Day 1, Urine protein, 1+
0
   0.0%
0
   0.0%
1
   7.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  25.0%
Cycle 1 Day 1, Urine protein, trace
0
   0.0%
1
  33.3%
2
  14.3%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
1
   4.0%
0
   0.0%
Cycle 2, Day 1, Urine protein, trace
0
   0.0%
0
   0.0%
1
   7.1%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
Cycle 2, Day 1, Urine protein, 2+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
Cycle 4, Day 1, Urine protein, trace
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   8.0%
1
  12.5%
Cycle 8, Day 1, Urine protein, trace
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
  12.0%
0
   0.0%
Cycle 12, Day 1, Urine protein, trace
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.0%
0
   0.0%
Cycle 16, Day 1, Urine protein, trace
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
15.Primary Outcome
Title Number of Participants With Hematology Change From Baseline With Respect to the Normal Range
Hide Description Hematology parameters included platelet Count, red blood cell (RBC) Count, hemoglobin, absolute white blood cell (WBC) Count, absolute neutrophils (Neu), absolute lymphocytes (Lym), absolute monocytes (Mono), absolute eosinophils (Eos), absolute basophils (Baso). Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. Hematology parameters with worst-case change from Baseline with respect to normal range only has been presented. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Median of 28.5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Subjects Population
Arm/Group Title 5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Hide Arm/Group Description:
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Overall Number of Participants Analyzed 3 3 14 3 3 3 3 25 8
Measure Type: Count of Participants
Unit of Measure: Participants
Baso, decrease to low, n=3,3,14,3,3,3,3,22,8 Number Analyzed 3 participants 3 participants 14 participants 3 participants 3 participants 3 participants 3 participants 22 participants 8 participants
0
   0.0%
0
   0.0%
1
   7.1%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
5
  22.7%
1
  12.5%
Baso, normal or no change, n=3,3,14,3,3,3,3,22,8 Number Analyzed 3 participants 3 participants 14 participants 3 participants 3 participants 3 participants 3 participants 22 participants 8 participants
3
 100.0%
3
 100.0%
9
  64.3%
3
 100.0%
1
  33.3%
3
 100.0%
3
 100.0%
13
  59.1%
6
  75.0%
Baso, increase to high, n=3,3,14,3,3,3,3,22,8 Number Analyzed 3 participants 3 participants 14 participants 3 participants 3 participants 3 participants 3 participants 22 participants 8 participants
0
   0.0%
0
   0.0%
4
  28.6%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
4
  18.2%
1
  12.5%
Eos, decrease to low, n=3,3,14,3,3,3,3,24,8 Number Analyzed 3 participants 3 participants 14 participants 3 participants 3 participants 3 participants 3 participants 24 participants 8 participants
0
   0.0%
0
   0.0%
1
   7.1%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
8
  33.3%
3
  37.5%
Eos, normal or no change, n=3,3,14,3,3,3,3,24,8 Number Analyzed 3 participants 3 participants 14 participants 3 participants 3 participants 3 participants 3 participants 24 participants 8 participants
3
 100.0%
3
 100.0%
11
  78.6%
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
14
  58.3%
5
  62.5%
Eos, increase to high, n=3,3,14,3,3,3,3,24,8 Number Analyzed 3 participants 3 participants 14 participants 3 participants 3 participants 3 participants 3 participants 24 participants 8 participants
0
   0.0%
0
   0.0%
2
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5
  20.8%
1
  12.5%
Mono, decrease to low, n=3,3,14,3,3,3,3,25,8 Number Analyzed 3 participants 3 participants 14 participants 3 participants 3 participants 3 participants 3 participants 25 participants 8 participants
3
 100.0%
2
  66.7%
11
  78.6%
0
   0.0%
2
  66.7%
1
  33.3%
2
  66.7%
6
  24.0%
3
  37.5%
Mono, normal or no change, n=3,3,14,3,3,3,3,25,8 Number Analyzed 3 participants 3 participants 14 participants 3 participants 3 participants 3 participants 3 participants 25 participants 8 participants
1
  33.3%
0
   0.0%
4
  28.6%
2
  66.7%
0
   0.0%
0
   0.0%
2
  66.7%
12
  48.0%
3
  37.5%
Mono, increase to high, n=3,3,14,3,3,3,3,25,8 Number Analyzed 3 participants 3 participants 14 participants 3 participants 3 participants 3 participants 3 participants 25 participants 8 participants
0
   0.0%
3
 100.0%
5
  35.7%
1
  33.3%
3
 100.0%
2
  66.7%
0
   0.0%
10
  40.0%
5
  62.5%
RBC, decrease to low, n=3,3,14,3,3,3,3,25,8 Number Analyzed 3 participants 3 participants 14 participants 3 participants 3 participants 3 participants 3 participants 25 participants 8 participants
3
 100.0%
2
  66.7%
10
  71.4%
0
   0.0%
1
  33.3%
2
  66.7%
1
  33.3%
17
  68.0%
3
  37.5%
RBC, normal or no change, n=3,3,14,3,3,3,3,25,8 Number Analyzed 3 participants 3 participants 14 participants 3 participants 3 participants 3 participants 3 participants 25 participants 8 participants
0
   0.0%
1
  33.3%
4
  28.6%
3
 100.0%
2
  66.7%
1
  33.3%
2
  66.7%
9
  36.0%
4
  50.0%
RBC, increase to high, n=3,3,14,3,3,3,3,25,8 Number Analyzed 3 participants 3 participants 14 participants 3 participants 3 participants 3 participants 3 participants 25 participants 8 participants
0
   0.0%
0
   0.0%
1
   7.1%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
3
  12.0%
1
  12.5%
16.Primary Outcome
Title Number of Participants With Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD)
Hide Description The MTD is defined as the highest dose level tested at which < 33 percent of participants experience a DLT. In cases when MTD is not reached dose was described as the MFD.
Time Frame Median of 28.5 weeks
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All Treated Subjects Population
Arm/Group Title 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Docetaxel: Arm B 15 mg/kg GSK3052230 + Pemetrexed + Carboplatin: Arm C
Hide Arm/Group Description:
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Overall Number of Participants Analyzed 14 3 25
Measure Type: Count of Participants
Unit of Measure: Participants
14
 100.0%
3
 100.0%
25
 100.0%
17.Primary Outcome
Title Number of Participants With Best Response
Hide Description Best response defined as complete response (CR:disappearance of all target. Any pathological lymph nodes < 10 millimeter [mm] in the short axis) or partial response (PR at least a 30 percent decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters), stable disease (SD neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) or progressive disease (PR at least a 20 percent increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or modified RECIST. Best response as per RECIST version 1.1 for Arm A and B participants has been reported. Best response according to RECIST version 1.1 or modified RECIST for Arm C participants has been reported.
Time Frame Median of 28.5 weeks
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All Evaluable Subjects Population
Arm/Group Title 5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Hide Arm/Group Description:
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Overall Number of Participants Analyzed 3 3 13 3 3 3 3 25 8
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Partial Response
1
  33.3%
2
  66.7%
6
  46.2%
0
   0.0%
0
   0.0%
0
   0.0%
2
  66.7%
11
  44.0%
1
  12.5%
Stable disease, discontinued
1
  33.3%
1
  33.3%
5
  38.5%
2
  66.7%
2
  66.7%
2
  66.7%
1
  33.3%
10
  40.0%
2
  25.0%
Stable disease, ongoing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   8.0%
0
   0.0%
Progressive disease
1
  33.3%
0
   0.0%
2
  15.4%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.0%
1
  12.5%
18.Primary Outcome
Title Number of Participants With Overall Response Rate (ORR)
Hide Description Overall Response Rate (ORR) is defined as the percentage of participants achieving a confirmed Complete response (CR) or Partial response (PR) from the start of treatment until disease progression as per RECIST version 1.1 or modified RECIST for participants in Arm C. This was determined based on Investigator assessments of response. 95% confidence intervals (CI) are calculated based on the unconditional exact method. ORR as per RECIST vesrion 1.1 for Arm A and B has been reported. ORR as per RECIST version 1.1 and modified RECIST version 1.1 for Arm C has been reported. The study population used for decision-making at the interim analyses during the dose expansion cohorts of the study arms is termed as the All Evaluable Participants Population. NA indicates 0 participants met ORR criteria therefore no dispersion.
Time Frame Median of 28.5 weeks
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All Evaluable Subjects Population
Arm/Group Title 5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Hide Arm/Group Description:
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Overall Number of Participants Analyzed 3 3 13 3 3 3 3 25 8
Measure Type: Count of Participants
Unit of Measure: Participants
1
  33.3%
2
  66.7%
6
  46.2%
0
   0.0%
0
   0.0%
0
   0.0%
2
  66.7%
11
  44.0%
1
  12.5%
19.Secondary Outcome
Title Progression Free Survival (PFS) as Assessed by Investigator
Hide Description PFS is defined as the interval between first dose of GSK3052230 and the earliest date of disease progression or death due to any cause by investigator assessment per RECIST 1.1 (for Arm A and B participants) or modified RECIST (for Arm C participants). For participants who do not progress or die, PFS was censored at the time of last radiological scan. Participants who discontinued study with no post-treatment tumor assessment were censored at date of first dose of study drug. Mean and 95 percent CI has been reported. NA indicates that data were not available as only 1 participant had event, other two censored therefore there is no confidence interval.
Time Frame Median of 28.5 weeks
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Hide Analysis Population Description
All Evaluable Subjects Population
Arm/Group Title 5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Hide Arm/Group Description:
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Overall Number of Participants Analyzed 3 3 13 3 3 3 3 25 8
Median (95% Confidence Interval)
Unit of Measure: Months
4.1
(1.4 to 5.5)
NA [1] 
(5.0 to NA)
5.5
(3.7 to 6.2)
4.6
(1.3 to 4.6)
9.5 [1] 
(NA to NA)
5.1
(4.0 to 6.2)
4.6 [1] 
(NA to NA)
7.4
(6.7 to 13.4)
4.1
(0.9 to 8.3)
[1]
NA indicates that data were not available as only 1 participant had event, other two censored therefore there is no confidence interval
20.Secondary Outcome
Title Clearance of GSK3052230
Hide Description Serial blood sample were collected at an indicated time points. A nonlinear mixed effects model was used to determine clearances. The Pharmacokinetic Population (PK) consisted of all participants in the All Treated Subject Population for whom a blood sample for pharmacokinetics was obtained and analyzed. Plasma GSK3052230 concentration-time data were to be combined with data from other studies to be analyzed using a population PK approach. However, other studies with GSK3052230 were not performed and thus no population PK analyses were done.
Time Frame Cycle(C)1 Day (D) 1 Pre-dose, End of infusion, 1 and 2 hours post-dose;C1 D8 Pre-dose,end of infusion; C2 D1 Pre-dose, End of infusion, 1 and 2 hours post-dose;C4 D1 Predose, end of infusion;C6 D1 Pre-dose, end of infusion,C12 D1 Pre-dose, end of infusion
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Pharmacokinetic Population
Arm/Group Title 5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Hide Arm/Group Description:
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
21.Secondary Outcome
Title Volume of Distribution of GSK3052230
Hide Description Serial blood sample were collected at an indicated time points. A nonlinear mixed effects model was used to determine volume distribution. Plasma GSK3052230 concentration-time data were to be combined with data from other studies to be analyzed using a population PK approach. However, other studies with GSK3052230 were not performed and thus no population PK analyses were done.
Time Frame Cycle(C)1 Day (D) 1 Pre-dose, End of infusion, 1 and 2 hours post-dose;C1 D8 Pre-dose,end of infusion; C2 D1 Pre-dose, End of infusion, 1 and 2 hours post-dose;C4 D1 Predose, end of infusion;C6 D1 Pre-dose, end of infusion,C12 D1 Pre-dose, end of infusion
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Pharmacokinetic Population
Arm/Group Title 5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Hide Arm/Group Description:
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
22.Secondary Outcome
Title Number of Participants With Relevant Covariates That Influence Exposure of GSK3052230
Hide Description Relevant covariates included parameters like age, weight and disease related covariates. Plasma GSK3052230 concentration-time data were to be combined with data from other studies to be analyzed using a population PK approach. However, other studies with GSK3052230 were not performed and thus no population PK analyses were done.
Time Frame Cycle(C)1 Day (D) 1 Pre-dose, End of infusion, 1 and 2 hours post-dose;C1 D8 Pre-dose,end of infusion; C2 D1 Pre-dose, End of infusion, 1 and 2 hours post-dose;C4 D1 Predose, end of infusion;C6 D1 Pre-dose, end of infusion,C12 D1 Pre-dose, end of infusion
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Pharmacokinetic Population
Arm/Group Title 5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Hide Arm/Group Description:
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
23.Secondary Outcome
Title Change From Baseline in Forced Vital Capacity (FVC) in of Arm C Participants With Malignant Pleural Mesothelioma (MPM)
Hide Description FVC is the total amount of air exhaled during the Forced Expiratory Volume test. Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. Assessment of FVC was done on Day 1 of every odd cycle for Arm C participants with MPM. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available as standard deviation could not be calculated for a single participant.
Time Frame Up to 31 cycles (each cycle was of 21 days)
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All Treated Subjects Population
Arm/Group Title 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Hide Arm/Group Description:
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Overall Number of Participants Analyzed 3 25 8
Mean (Standard Deviation)
Unit of Measure: Liters
Cycle 3,Day 1, n=3, 24, 4 Number Analyzed 3 participants 24 participants 4 participants
0.303  (0.4688) 0.280  (0.2911) 0.138  (0.6762)
Cycle 4,Day 1, n=1, 4, 1 Number Analyzed 1 participants 4 participants 1 participants
-0.340 [1]   (NA) 0.413  (0.1144) 0.600 [1]   (NA)
Cycle 5,Day 1, n=1, 23, 3 Number Analyzed 1 participants 23 participants 3 participants
0.240 [1]   (NA) 0.238  (0.4178) 0.587  (0.3592)
Cycle 6,Day 1, n=1, 5, 2 Number Analyzed 1 participants 5 participants 2 participants
0.310 [1]   (NA) 0.464  (0.3544) 0.110  (0.8061)
Cycle 7,Day 1, n=1, 15, 2 Number Analyzed 1 participants 15 participants 2 participants
0.530 [1]   (NA) 0.399  (0.478) 0.575  (0.0778)
Cycle 8,Day 1, n=0, 3, 1 Number Analyzed 0 participants 3 participants 1 participants
0.263  (0.2371) 0.640 [1]   (NA)
Cycle 9,Day 1, n=0, 15, 1 Number Analyzed 0 participants 15 participants 1 participants
0.353  (0.4621) 1.130 [1]   (NA)
Cycle 10,Day 1, n=0, 3, 0 Number Analyzed 0 participants 3 participants 0 participants
0.063  (0.0751)
Cycle 11,Day 1, n=0, 12, 2 Number Analyzed 0 participants 12 participants 2 participants
0.347  (0.391) 0.510  (0.6081)
Cycle 12,Day 1, n=0, 2, 1 Number Analyzed 0 participants 2 participants 1 participants
0.225  (0.2333) 0.580 [1]   (NA)
Cycle 13,Day 1, n=0, 8, 2 Number Analyzed 0 participants 8 participants 2 participants
0.389  (0.42) 0.555  (0.5162)
Cycle 14,Day 1, n=0, 3, 1 Number Analyzed 0 participants 3 participants 1 participants
-0.207  (0.65770) 0.910 [1]   (NA)
Cycle 15,Day 1, n=0, 6, 1 Number Analyzed 0 participants 6 participants 1 participants
0.247  (0.3406) -0.030 [1]   (NA)
Cycle 17,Day 1, n=0, 4, 1 Number Analyzed 0 participants 4 participants 1 participants
0.158  (0.3402) 0.560 [1]   (NA)
Cycle 19,Day 1, n=0, 1, 1 Number Analyzed 0 participants 1 participants 1 participants
-0.02 [1]   (NA) 0.620 [1]   (NA)
Cycle 21,Day 1, n=0, 1, 1 Number Analyzed 0 participants 1 participants 1 participants
-0.27 [1]   (NA) 0.560 [1]   (NA)
Cycle 23,Day 1, n=0, 1, 1 Number Analyzed 0 participants 1 participants 1 participants
-0.62 [1]   (NA) 0.510 [1]   (NA)
Cycle 25,Day 1, n=0, 0, 1 Number Analyzed 0 participants 0 participants 1 participants
0.430 [1]   (NA)
Cycle 27,Day 1, n=0, 0, 1 Number Analyzed 0 participants 0 participants 1 participants
0.220 [1]   (NA)
Cycle 31,Day 1, n=0, 0, 1 Number Analyzed 0 participants 0 participants 1 participants
0.270 [1]   (NA)
[1]
NA indicates that data were not available as standard deviation could not be calculated for a single participant
Time Frame Serious adverse events (SAEs) and non-serious adverse events (AEs) were be collected from the start of study treatment and up to Median of 28.5 weeks.
Adverse Event Reporting Description All Treated Subjects Population
 
Arm/Group Title 5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Hide Arm/Group Description Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
All-Cause Mortality
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/3 (0.00%)      0/14 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      0/25 (0.00%)      1/8 (12.50%)    
Show Serious Adverse Events Hide Serious Adverse Events
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      3/3 (100.00%)      5/14 (35.71%)      2/3 (66.67%)      3/3 (100.00%)      1/3 (33.33%)      0/3 (0.00%)      5/25 (20.00%)      4/8 (50.00%)    
Blood and lymphatic system disorders                   
Febrile neutropenia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 2/14 (14.29%)  3 0/3 (0.00%)  0 2/3 (66.67%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 0/8 (0.00%)  0
Neutropenia  1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/14 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 0/8 (0.00%)  0
Thrombocytopenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 1/8 (12.50%)  2
Cardiac disorders                   
Myocardial infarction  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 0/8 (0.00%)  0
Pericardial effusion  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 0/8 (0.00%)  0
Gastrointestinal disorders                   
Diarrhoea  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/14 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/25 (4.00%)  1 0/8 (0.00%)  0
Abdominal pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 0/8 (0.00%)  0
Intestinal ischaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 1/8 (12.50%)  1
Intestinal perforation  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 1/8 (12.50%)  1
Nausea  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/25 (4.00%)  1 0/8 (0.00%)  0
General disorders                   
Asthenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/25 (0.00%)  0 0/8 (0.00%)  0
Pyrexia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 0/8 (0.00%)  0
Infections and infestations                   
Respiratory tract infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/14 (14.29%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 0/8 (0.00%)  0
Lung infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 0/8 (0.00%)  0
Stenotrophomonas infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 0/8 (0.00%)  0
Clostridium difficile infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/25 (4.00%)  1 0/8 (0.00%)  0
Pneumonia pseudomonal  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/25 (4.00%)  1 0/8 (0.00%)  0
Urinary tract infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/25 (4.00%)  1 0/8 (0.00%)  0
Injury, poisoning and procedural complications                   
Infusion related reaction  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/25 (4.00%)  1 1/8 (12.50%)  2
Femur fracture  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 1/8 (12.50%)  1
Investigations                   
Blood creatinine increased  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/25 (4.00%)  2 0/8 (0.00%)  0
Metabolism and nutrition disorders                   
Diabetes mellitus  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 0/8 (0.00%)  0
Nervous system disorders                   
Ataxia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 0/8 (0.00%)  0
Nervous system disorder  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 1/8 (12.50%)  1
Psychiatric disorders                   
Confusional state  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/14 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 0/8 (0.00%)  0
Renal and urinary disorders                   
Acute kidney injury  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 1/8 (12.50%)  2
Respiratory, thoracic and mediastinal disorders                   
Pleural effusion  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 1/8 (12.50%)  1
Pulmonary embolism  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/25 (4.00%)  1 0/8 (0.00%)  0
Respiratory failure  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 1/8 (12.50%)  1
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A 5 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Docetaxel: Arm B 20 mg/kg GSK3052230 + Docetaxel: Arm B 10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C 20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      3/3 (100.00%)      14/14 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      24/25 (96.00%)      8/8 (100.00%)    
Blood and lymphatic system disorders                   
Neutropenia  1  2/3 (66.67%)  4 1/3 (33.33%)  14 12/14 (85.71%)  50 1/3 (33.33%)  2 0/3 (0.00%)  0 2/3 (66.67%)  10 0/3 (0.00%)  0 6/25 (24.00%)  30 2/8 (25.00%)  6
Anaemia  1  2/3 (66.67%)  2 1/3 (33.33%)  1 5/14 (35.71%)  8 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 6/25 (24.00%)  12 3/8 (37.50%)  3
Leukopenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/14 (21.43%)  12 0/3 (0.00%)  0 0/3 (0.00%)  0 2/3 (66.67%)  10 0/3 (0.00%)  0 4/25 (16.00%)  12 1/8 (12.50%)  2
Thrombocytopenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/14 (21.43%)  8 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 0/8 (0.00%)  0
Pancytopenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/14 (7.14%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 0/8 (0.00%)  0
Leukocytosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 1/8 (12.50%)  1
Monocytosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 1/8 (12.50%)  1
Cardiac disorders                   
Cardiomegaly  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 0/8 (0.00%)  0
Tachycardia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/14 (7.14%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 1/8 (12.50%)  1
Acute coronary syndrome  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 0/8 (0.00%)  0
Angina pectoris  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 0/8 (0.00%)  0
Arrhythmia supraventricular  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/25 (0.00%)  0 0/8 (0.00%)  0
Ventricular tachycardia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 0/8 (0.00%)  0
Conduction disorder  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/25 (4.00%)  1 1/8 (12.50%)  1
Palpitations  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/25 (4.00%)  1 0/8 (0.00%)  0
Atrial fibrillation  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/25 (0.00%)  0 0/8 (0.00%)  0
Left ventricular hypertrophy  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 1/8 (12.50%)  2
Ventricular extrasystoles  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/14 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 1/8 (12.50%)  1
Ear and labyrinth disorders                   
Vertigo  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/14 (7.14%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/25 (0.00%)  0 0/8 (0.00%)  0
Tinnitus  1  0/3 (0.00%)