Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Phase 2a Study of BAX69 and 5-FU/Leucovorin or Panitumumab Versus Standard of Care in Subjects With Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02448810
Recruitment Status : Terminated (Based on overall benefit-risk assessment.)
First Posted : May 20, 2015
Results First Posted : March 19, 2018
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Colorectal Cancer
Interventions Biological: BAX69 + infusional 5-FU/LV
Biological: BAX69 + panitumumab
Biological: BAX69 + 5-FU/LV
Drug: Standard of Care
Biological: Standard of Care
Enrollment 115
Recruitment Details The study was conducted at 21 centers in the United States, the United Kingdom and Spain between 15 June 2015 (first participant first visit) and 15 February 2017 (last participant last visit).
Pre-assignment Details Overall (part 1 and 2) 115 participants were screened, 85 participants were randomized and 79 participants were treated. In part 1, 17 participants were screened, 5 failed screening, 12 were randomized and treated. In part 2, 98 participants were screened, 17 failed screening and 8 did not start the study, 73 were randomized and 67 were treated.
Arm/Group Title Part 1: Imalumab 7.5 mg/kg + 5-FU/LV Part 1: Imalumab 7.5 mg/kg + Panitumumab Part 1: Imalumab 10 mg/kg + 5-FU/LV Part 1: Imalumab 10 mg/kg + Panitumumab Part 2: Imalumab 10 mg/kg + 5-FU/LV Part 2: Standard of Care Mutant Part 2: Imalumab 10 mg/kg + Panitumumab Part 2: Standard of Care Wild Type
Hide Arm/Group Description Participants with mutated tumors (mutated kirsten rat sarcoma viral oncogene homolog, mutated neuroblastoma rat sarcoma viral oncogene homolog [KRAS mut, NRAS mut]) received 7.5 milligram per kilogram (mg/kg) dose of imalumab every week (QW) in combination with 5-fluorouracil/leucovorin ([FU/LV] LV 400 milligram per square meter [mg/m^2] intravenous (IV) infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) for every 2 weeks (Q2W) IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. Participants with wild-type tumors (wild type Kirsten rat sarcoma viral oncogene homolog, wild neuroblastoma rat sarcoma viral oncogene homolog [KRAS wt, NRAS wt]) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Period Title: Overall Study
Started 3 3 3 3 31 16 18 8
Treated 3 3 3 3 29 13 18 7
Completed 0 0 0 0 0 0 0 0
Not Completed 3 3 3 3 31 16 18 8
Reason Not Completed
Adverse Event             0             0             1             0             0             0             0             0
Withdrawal by Subject             0             0             1             0             3             5             0             2
Other (study terminated by sponsor)             0             0             0             0             4             2             2             1
Death             1             0             1             0             1             0             0             0
Other (Progressive disease)             2             2             0             3             23             9             14             5
Lost to Follow-up             0             1             0             0             0             0             0             0
Other (unspecified)             0             0             0             0             0             0             2             0
Arm/Group Title Part 1: Imalumab 7.5 mg/kg + 5-FU/LV Part 1: Imalumab 7.5 mg/kg + Panitumumab Part 1: Imalumab 10 mg/kg + 5-FU/LV Part 1: Imalumab 10 mg/kg + Panitumumab Part 2: Imalumab 10 mg/kg + 5-FU/LV Part 2: Standard of Care Mutant Part 2: Imalumab 10 mg/kg + Panitumumab Part 2: Standard of Care Wild Type Total
Hide Arm/Group Description Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. Total of all reporting groups
Overall Number of Baseline Participants 3 3 3 3 31 16 18 8 85
Hide Baseline Analysis Population Description
Safety analysis set (SAS) included all participants who received at least 1 administration of study drug. Baseline was calculated only for the treated participants and not for the enrolled participants.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 31 participants 16 participants 18 participants 8 participants 85 participants
<=18 years
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%
Between 18 and 65 years
1
  33.3%
0
   0.0%
3
 100.0%
2
  66.7%
21
  67.7%
12
  75.0%
13
  72.2%
5
  62.5%
57
  67.1%
>=65 years
2
  66.7%
3
 100.0%
0
   0.0%
1
  33.3%
10
  32.3%
4
  25.0%
5
  27.8%
3
  37.5%
28
  32.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 31 participants 16 participants 18 participants 8 participants 85 participants
Female
1
  33.3%
0
   0.0%
0
   0.0%
1
  33.3%
13
  41.9%
5
  31.3%
7
  38.9%
6
  75.0%
33
  38.8%
Male
2
  66.7%
3
 100.0%
3
 100.0%
2
  66.7%
18
  58.1%
11
  68.8%
11
  61.1%
2
  25.0%
52
  61.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 31 participants 16 participants 18 participants 8 participants 85 participants
Hispanic or Latino
0
   0.0%
1
  33.3%
0
   0.0%
1
  33.3%
5
  16.1%
2
  12.5%
3
  16.7%
0
   0.0%
12
  14.1%
Not Hispanic or Latino
3
 100.0%
2
  66.7%
3
 100.0%
2
  66.7%
26
  83.9%
14
  87.5%
15
  83.3%
8
 100.0%
73
  85.9%
Unknown or Not Reported
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%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 31 participants 16 participants 18 participants 8 participants 85 participants
American Indian or Alaska Native
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%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.2%
2
  12.5%
0
   0.0%
0
   0.0%
3
   3.5%
Native Hawaiian or Other Pacific Islander
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%
Black or African American
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
4
  12.9%
0
   0.0%
0
   0.0%
2
  25.0%
7
   8.2%
White
2
  66.7%
3
 100.0%
3
 100.0%
2
  66.7%
26
  83.9%
14
  87.5%
18
 100.0%
6
  75.0%
74
  87.1%
More than one race
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%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.2%
1.Primary Outcome
Title Part 2: Progression-Free Survival (PFS)
Hide Description PFS was defined as time between treatment initiation and tumor progression (per Response Evaluation Criteria in Solid Tumors [RECIST] v1.1 criteria) or death from any cause, with censoring of participants who were lost to follow-up or withdrew consent.
Time Frame From start of the study up to safety follow-up visit occurred (30 [-/+7]) days after the last dose of study treatment or until disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all participants who received at least 1 administration of study drug, and who had 1 postbaseline tumor response assessment based on RECIST v1.1, or died within 18 weeks of the start of treatment.
Arm/Group Title Part 2: Imalumab 10 mg/kg + 5-FU/LV Part 2: Standard of Care Mutant Part 2: Imalumab 10 mg/kg + Panitumumab Part 2: Standard of Care Wild Type
Hide Arm/Group Description:
Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Overall Number of Participants Analyzed 29 12 18 7
Median (95% Confidence Interval)
Unit of Measure: weeks
11.1
(8.4 to 16.1)
8.3
(7.4 to 23.3)
9.3
(8.1 to 24.9)
7.3 [1] 
(3.7 to NA)
[1]
Upper limit was not available.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 2: Imalumab 10 mg/kg + 5-FU/LV, Part 2: Standard of Care Mutant
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.246
Comments P-value is based on a one-sided log-rank test.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.8
Confidence Interval (2-Sided) 70%
0.5 to 1.1
Estimation Comments [Not Specified]
Other Statistical Analysis Hazard Ratio and 70% CI are based on a Cox proportional hazards model with a covariate for treatment (imalumab vs SoC).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 2: Imalumab 10 mg/kg + Panitumumab, Part 2: Standard of Care Wild Type
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.354
Comments P-value is based on a one-sided log-rank test.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.8
Confidence Interval (2-Sided) 70%
0.5 to 1.4
Estimation Comments [Not Specified]
Other Statistical Analysis Hazard Ratio and 70% CI are based on a Cox proportional hazards model with a covariate for treatment (imalumab vs SoC).
2.Primary Outcome
Title Part 1: Number of Participants With Occurrence of Dose Limiting Toxicity (DLT)
Hide Description DLT was defined as any drug-related treatment-emergent adverse event (TEAE) (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v4.03) that occurs during the first 28 days after treatment start and that meets any of the following criteria: i) Any >= Grade 3 non-hematologic toxicity (excluding: mucositis/stomatitis of Grade 3; diarrhea of <3 days duration; nausea and vomiting <3 days duration; fatigue of <7 days duration; alopecia; single laboratory value out of the normal range that has no clinical significance and that resolves to <= Grade 2 with adequate measures within 7 days) ii) Any Grade 4 hematologic toxicity (excluding: grade 4 neutropenia lasting for <= 5 days; isolated grade 4 lymphocytopenia) iii) Grade 3 febrile neutropenia iv) Grade 3 thrombocytopenia associated with bleeding v) Any life-threatening complication or abnormality not covered in NCI CTCAEv4.03.
Time Frame From start of study treatment up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all participants who received at least 1 administration of study drug.
Arm/Group Title Part 1: Imalumab 7.5 mg/kg + 5-Fluorouracil/Leucovorin (FU/LV) Part 1: Imalumab 7.5 mg/kg + Panitumumab Part 1: Imalumab 10 mg/kg + 5-FU/LV Part 1: Imalumab 10 mg/kg + Panitumumab
Hide Arm/Group Description:
Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Overall Number of Participants Analyzed 3 3 3 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies
Hide Description Number of participants with occurrence of binding and/or neutralizing anti-imalumab antibodies were reported.
Time Frame From start of study drug administration up to end of treatment (EOT) (approximately 21 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all participants who received at least 1 administration of study drug.
Arm/Group Title Part 1: Imalumab 7.5 mg/kg + 5-Fluorouracil/Leucovorin (FU/LV) Part 1: Imalumab 7.5 mg/kg + Panitumumab Part 1: Imalumab 10 mg/kg + 5-FU/LV Part 1: Imalumab 10 mg/kg + Panitumumab Part 2: Imalumab 10 mg/kg + 5-FU/LV Part 2: Standard of Care Mutant Part 2: Imalumab 10 mg/kg + Panitumumab Part 2: Standard of Care Wild Type
Hide Arm/Group Description:
Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Overall Number of Participants Analyzed 3 3 3 3 29 13 18 7
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline (Binding antibody) Number Analyzed 3 participants 3 participants 3 participants 1 participants 27 participants 12 participants 18 participants 6 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.6%
0
   0.0%
End of Study (Binding antibody) Number Analyzed 2 participants 1 participants 3 participants 1 participants 19 participants 2 participants 12 participants 2 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Baseline (Neutralizing antibody) Number Analyzed 3 participants 3 participants 3 participants 1 participants 27 participants 12 participants 18 participants 6 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
End of Study (Neutralizing antibody) Number Analyzed 2 participants 1 participants 3 participants 1 participants 19 participants 2 participants 12 participants 2 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Number of Participants With Incidence of Infusion Reactions After Imalumab Administration
Hide Description Infusion reaction was defined as any relevant sign or symptom occurring during or after imalumab infusion and considered by the investigator as an infusion reaction.
Time Frame From start of study drug administration up to EOT (approximately 21 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all participants who received at least 1 administration of study drug.
Arm/Group Title Part 1: Imalumab 7.5 mg/kg + 5-Fluorouracil/Leucovorin (FU/LV) Part 1: Imalumab 7.5 mg/kg + Panitumumab Part 1: Imalumab 10 mg/kg + 5-FU/LV Part 1: Imalumab 10 mg/kg + Panitumumab Part 2: Imalumab 10 mg/kg + 5-FU/LV Part 2: Standard of Care Mutant Part 2: Imalumab 10 mg/kg + Panitumumab Part 2: Standard of Care Wild Type
Hide Arm/Group Description:
Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Overall Number of Participants Analyzed 3 3 3 3 29 13 18 7
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%
1
   5.6%
0
   0.0%
5.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events (TEAEs)
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any AE that results in any of the following outcomes: death, a life-threatening event, inpatient hospitalization or prolongation of an existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, other medically important events based upon appropriate medical judgement. TEAEs was defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments.
Time Frame From start of study drug administration up to EOT (approximately 21 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all participants who received at least 1 administration of study drug.
Arm/Group Title Part 1: Imalumab 7.5 mg/kg + 5-Fluorouracil/Leucovorin (FU/LV) Part 1: Imalumab 7.5 mg/kg + Panitumumab Part 1: Imalumab 10 mg/kg + 5-FU/LV Part 1: Imalumab 10 mg/kg + Panitumumab Part 2: Imalumab 10 mg/kg + 5-FU/LV Part 2: Standard of Care Mutant Part 2: Imalumab 10 mg/kg + Panitumumab Part 2: Standard of Care Wild Type
Hide Arm/Group Description:
Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Overall Number of Participants Analyzed 3 3 3 3 29 13 18 7
Measure Type: Count of Participants
Unit of Measure: Participants
SAEs
1
  33.3%
1
  33.3%
1
  33.3%
2
  66.7%
15
  51.7%
8
  61.5%
7
  38.9%
2
  28.6%
TEAEs
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
28
  96.6%
13
 100.0%
17
  94.4%
7
 100.0%
6.Secondary Outcome
Title Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Hide Description Number of participants with response evaluation according to RECIST v1.1 was evaluated according to complete response (CR): disappearance of all target and non-target lesions and no new lesions; partial response (PR): >= 30 percent (%) decrease in the sum of diameters of target lesions (compared to baseline) and no new lesions; stable disease (SD): neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; progressive disease (PD): >= 20% increase in the sum of diameters of target lesions and an absolute increase in sum of diameters of >=5 millimeter (mm) (compared to the previous minimum sum) or progression of a new lesion.
Time Frame Day 28 of Cycle 2 followed by every 2 Cycles of 28 day Cycles: Day 56, Day 112, Day 168 and Day 224
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 administration of study drug, and had 1 postbaseline tumor response assessment based on RECIST v1.1, or died within 18 weeks of the start of treatment.
Arm/Group Title Part 1: Imalumab 7.5 mg/kg + 5-Fluorouracil/Leucovorin (FU/LV) Part 1: Imalumab 7.5 mg/kg + Panitumumab Part 1: Imalumab 10 mg/kg + 5-FU/LV Part 1: Imalumab 10 mg/kg + Panitumumab Part 2: Imalumab 10 mg/kg + 5-FU/LV Part 2: Standard of Care Mutant Part 2: Imalumab 10 mg/kg + Panitumumab Part 2: Standard of Care Wild Type
Hide Arm/Group Description:
Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Overall Number of Participants Analyzed 3 3 3 3 29 12 18 7
Measure Type: Count of Participants
Unit of Measure: Participants
Best Overall Response: Complete Response (CR)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Best Overall Response: Partial Response (PR)
0
   0.0%
2
  66.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
  16.7%
1
  14.3%
Best Overall Response: Stable Disease (SD)
1
  33.3%
1
  33.3%
2
  66.7%
1
  33.3%
14
  48.3%
4
  33.3%
6
  33.3%
2
  28.6%
Best Overall Response: Progressive Disease (PD)
2
  66.7%
0
   0.0%
1
  33.3%
2
  66.7%
15
  51.7%
7
  58.3%
8
  44.4%
4
  57.1%
Best Overall Response: Not Evaluable (NE)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
1
   5.6%
0
   0.0%
7.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time from randomization until death due to any cause. Here, number of participants analyzed was based on the number of participants who underwent death.
Time Frame From start of study drug administration up to EOT (approximately 21 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least 1 administration of study drug, and had 1 postbaseline tumor response assessment based on RECIST v1.1, or died within 18 weeks of the start of treatment.
Arm/Group Title Part 1: Imalumab 7.5 mg/kg + 5-Fluorouracil/Leucovorin (FU/LV) Part 1: Imalumab 7.5 mg/kg + Panitumumab Part 1: Imalumab 10 mg/kg + 5-FU/LV Part 1: Imalumab 10 mg/kg + Panitumumab Part 2: Imalumab 10 mg/kg + 5-FU/LV Part 2: Standard of Care Mutant Part 2: Imalumab 10 mg/kg + Panitumumab Part 2: Standard of Care Wild Type
Hide Arm/Group Description:
Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Overall Number of Participants Analyzed 3 3 2 3 16 10 8 3
Median (95% Confidence Interval)
Unit of Measure: weeks
24.9
(7.4 to 40.4)
42.7
(15.4 to 77.4)
42.7
(16.9 to 42.7)
24.9
(9.4 to 42.1)
31.9
(26.3 to 58.0)
27.2
(9.3 to 46.7)
31.4 [1] 
(19.9 to NA)
NA [1] 
(NA to NA)
[1]
The median and 95% confidence interval was not available due to insufficient number of events at the end of the study.
8.Secondary Outcome
Title Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Hide Description EORTC QLQ-C30 was a validated instrument used to measure QoL and assess symptoms and side effects of treatment and the impact on everyday life.The QLQ-C30 was composed of: A) 5 multi-item functioning scales(physical, role, social, emotional and cognitive), that were answered on a 4-point scale (1=Not at all,2=A Little,3=Quite a Bit,4=Very Much). Each score range from 0 to 100 with a higher score representing a higher level of functioning and a better QoL. B) A global health status/QoL scale that was answered on a 7-point scale (1=Very Poor to 7=Excellent). Each score range from 0 to 100 with a higher score representing a better QoL. C) 9 symptom scales(fatigue, nausea/vomiting,pain,financial impact/difficulties,appetite loss,diarrhea, constipation,sleep disturbance/insomnia and dyspnea), that were answered on a 4-point scale (1=Not at all,2=A Little,3=Quite a Bit,4=Very Much). Each score range from 0 to 100 with a higher score representing a greater degree of symptoms and a worse QoL.
Time Frame Baseline, 21 Months (EOT) up to follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
SAS included all participants who received at least 1 administration of study drug.
Arm/Group Title Part 1: Imalumab 7.5 mg/kg + 5-Fluorouracil/Leucovorin (FU/LV) Part 1: Imalumab 7.5 mg/kg + Panitumumab Part 1: Imalumab 10 mg/kg + 5-FU/LV Part 1: Imalumab 10 mg/kg + Panitumumab Part 2: Imalumab 10 mg/kg + 5-FU/LV Part 2: Standard of Care Mutant Part 2: Imalumab 10 mg/kg + Panitumumab Part 2: Standard of Care Wild Type
Hide Arm/Group Description:
Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
Overall Number of Participants Analyzed 3 3 3 3 29 13 18 7
Mean (Standard Deviation)
Unit of Measure: score on a scale
Global Health Status (Baseline) Number Analyzed 3 participants 3 participants 3 participants 3 participants 29 participants 13 participants 17 participants 7 participants
33.33  (16.665) 66.7  (8.335) 75  (8.330) 66.67  (16.665) 68.10  (18.510) 62.18  (25.371) 66.18  (22.529) 59.52  (19.501)
Global Health Status (change from baseline (CFB)) Number Analyzed 2 participants 0 participants 3 participants 1 participants 19 participants 8 participants 12 participants 5 participants
8.33  (35.355) -5.56  (4.812) -16.67 [1]   (NA) -13.16  (23.293) -13.54  (21.333) -10.42  (17.810) -11.67  (9.502)
Physical functioning scale (Baseline) Number Analyzed 3 participants 3 participants 3 participants 3 participants 28 participants 13 participants 18 participants 7 participants
63.33  (26.031) 75.56  (19.249) 88.89  (7.696) 80  (6.670) 78.45  (18.670) 81.15  (15.537) 78.89  (20.612) 70  (17.950)
Physical functioning scale (CFB) Number Analyzed 2 participants 0 participants 3 participants 1 participants 18 participants 8 participants 13 participants 5 participants
0  (0) -2.22  (7.699) -20 [1]   (NA) -5  (17.198) -21.04  (23.489) -4.10  (10.379) -14.67  (15.918)
Role functioning scale (Baseline) Number Analyzed 3 participants 3 participants 3 participants 3 participants 28 participants 13 participants 18 participants 7 participants
50  (50) 88.89  (19.243) 72.22  (9.619) 77.78  (19.243) 74.41  (24.630) 73.08  (30.076) 76.85  (19.078) 66.67  (25.459)
Role functioning scale (CFB) Number Analyzed 2 participants 0 participants 3 participants 1 participants 18 participants 8 participants 13 participants 5 participants
-25  (35.355) -16.67  (16.670) 0 [1]   (NA) -12.04  (24.122) -16.67  (43.642) -11.54  (29.957) -10  (14.910)
Emotional functioning scale (Baseline) Number Analyzed 3 participants 3 participants 3 participants 3 participants 28 participants 13 participants 17 participants 7 participants
79.67  (26.274) 97.22  (4.809) 91.67  (8.335) 83.33  (16.665) 78.87  (18.494) 73.08  (25.720) 77.45  (19.490) 66.66  (18.003)
Emotional functioning scale (CFB) Number Analyzed 2 participants 0 participants 3 participants 1 participants 18 participants 8 participants 12 participants 5 participants
-7  (13.675) -5.56  (17.346) -41.66 [1]   (NA) -3.24  (15.163) -1.04  (16.925) -2.78  (16.792) -11.66  (20.916)
Cognitive functioning scale (Baseline) Number Analyzed 3 participants 3 participants 3 participants 3 participants 28 participants 13 participants 17 participants 7 participants
83.33  (16.665) 88.89  (19.243) 100  (0) 83.33  (16.665) 88.10  (18.063) 89.74  (14.496) 93.14  (10.306) 83.33  (23.571)
Cognitive functioning scale (CFB) Number Analyzed 2 participants 0 participants 3 participants 1 participants 18 participants 8 participants 12 participants 5 participants
0  (0) 0  (0) -33.33 [1]   (NA) -1.85  (15.003) -27.08  (30.779) -8.33  (15.075) -6.67  (9.128)
Social functioning scale (Baseline) Number Analyzed 3 participants 3 participants 3 participants 3 participants 28 participants 13 participants 17 participants 7 participants
77.78  (25.458) 66.67  (0) 77.78  (9.619) 77.78  (9.619) 88.69  (15.080) 80.77  (24.387) 73.53  (29.498) 66.67  (27.215)
Social functioning scale (CFB) Number Analyzed 2 participants 0 participants 3 participants 1 participants 18 participants 8 participants 12 participants 5 participants
-8.34  (11.787) -22.22  (9.630) -33.34 [1]   (NA) -13.89  (25.726) -25  (15.430) 0  (38.924) -10  (19.004)
Fatigue symptom scale (Baseline) Number Analyzed 3 participants 3 participants 3 participants 3 participants 28 participants 13 participants 18 participants 7 participants
29.67  (28.015) 29.66  (6.351) 22.33  (0) 26  (6.351) 33.74  (20.645) 38.46  (28.580) 29.63  (19.041) 41.24  (21.943)
Fatigue symptom scale (CFB) Number Analyzed 2 participants 0 participants 3 participants 1 participants 18 participants 8 participants 13 participants 5 participants
44.50  (15.797) 29.45  (23.089) 44.34 [1]   (NA) 9.28  (19.828) 23.63  (19.197) 3.44  (21.919) 13.33  (18.209)
Nausea/vomiting symptom scale (Baseline) Number Analyzed 3 participants 3 participants 3 participants 3 participants 28 participants 13 participants 18 participants 7 participants
11.11  (19.243) 0  (0) 5.56  (9.624) 16.67  (16.665) 13.10  (22.843) 6.41  (10.841) 7.41  (11.746) 4.76  (8.134)
Nausea/vomiting symptom scale (CFB) Number Analyzed 2 participants 0 participants 3 participants 1 participants 18 participants 8 participants 13 participants 5 participants
25  (11.780) 5.55  (9.619) -16.66 [1]   (NA) 2.78  (24.421) 14.58  (20.773) 5.13  (30.720) 10  (14.906)
Pain symptom scale (Baseline) Number Analyzed 3 participants 3 participants 3 participants 3 participants 28 participants 13 participants 18 participants 7 participants
38.89  (38.486) 27.78  (9.619) 16.67  (16.665) 38.89  (19.243) 31.55  (27.719) 23.08  (30.074) 22.22  (17.149) 35.71  (29.546)
Pain symptom scale (CFB) Number Analyzed 2 participants 0 participants 3 participants 1 participants 18 participants 8 participants 13 participants 5 participants
41.66  (35.355) 11.11  (19.243) 0 [1]   (NA) 5.55  (21.390) 12.50  (21.362) 6.41  (19.882) 13.33  (18.258)
Dyspnea symptom scale (Baseline) Number Analyzed 3 participants 3 participants 3 participants 3 participants 28 participants 13 participants 18 participants 7 participants
11.11  (19.243) 11.11  (19.243) 0  (0) 22.22  (19.243) 11.90  (20.716) 20.51  (25.599) 14.81  (26.127) 9.52  (16.263)
Dyspnea symptom scale (CFB) Number Analyzed 2 participants 0 participants 3 participants 1 participants 18 participants 8 participants 13 participants 5 participants
33.34  (47.143) 11.11  (19.243) 33.33 [1]   (NA) 5.56  (20.612) 16.67  (30.861) 17.95  (17.296) 6.67  (27.886)
Sleep disturbance/insomnia symptom scale(Baseline) Number Analyzed 3 participants 3 participants 3 participants 3 participants 27 participants 13 participants 18 participants 7 participants
44.45  (38.492) 0  (0) 33.33  (0) 22.22  (19.243) 23.46  (28.964) 20.51  (25.599) 22.22  (25.566) 47.62  (42.415)
Sleep disturbance/insomnia symptom scale (CFB) Number Analyzed 2 participants 0 participants 3 participants 1 participants 17 participants 8 participants 13 participants 5 participants
-0.01  (47.143) 33.34  (33.335) 0 [1]   (NA) 7.84  (34.421) 12.50  (30.537) 7.69  (14.616) -6.67  (27.886)
Appetite loss symptom scale (Baseline) Number Analyzed 3 participants 3 participants 3 participants 3 participants 28 participants 13 participants 18 participants 7 participants
11.11  (19.243) 22.22  (38.492) 11.11  (19.243) 22.22  (19.243) 25  (33.488) 33.33  (38.490) 12.96  (20.256) 14.28  (17.816)
Appetite loss symptom scale (CFB) Number Analyzed 2 participants 0 participants 3 participants 1 participants 18 participants 8 participants 13 participants 5 participants
66.67  (0) 33.33  (33.335) 66.67 [1]   (NA) 9.26  (29.826) 4.17  (27.820) 7.69  (24.165) 20  (29.816)
Constipation symptom scale (Baseline) Number Analyzed 3 participants 3 participants 3 participants 3 participants 29 participants 13 participants 18 participants 7 participants
11.11  (19.243) 22.22  (19.243) 0  (0) 22.22  (19.243) 17.24  (26.157) 25.64  (30.895) 22.22  (28.005) 19.05  (26.227)
Constipation symptom scale (CFB) Number Analyzed 2 participants 0 participants 3 participants 1 participants 18 participants 8 participants 13 participants 5 participants
0  (0) 22.22  (38.492) 0 [1]   (NA) 7.41  (33.442) 16.67  (43.645) 2.56  (34.591) 6.67  (27.886)
Diarrhea symptom scale (Baseline) Number Analyzed 3 participants 3 participants 3 participants 3 participants 29 participants 13 participants 17 participants 7 participants
0  (0) 0  (0) 22.22  (19.243) 11.11  (19.243) 10.34  (18.046) 20.51  (34.798) 17.65  (26.660) 23.81  (25.198)
Diarrhea symptom scale (CFB) Number Analyzed 2 participants 0 participants 3 participants 1 participants 19 participants 8 participants 12 participants 5 participants
33.33  (0) 11.11  (19.243) -33.33 [1]   (NA) 8.77  (33.040) 8.33  (38.834) -11.11  (16.411) 0  (23.568)
Financial impact symptom scale (Baseline) Number Analyzed 3 participants 3 participants 3 participants 3 participants 29 participants 13 participants 17 participants 7 participants
11.11  (19.243) 11.11  (19.243) 44.44  (50.918) 44.44  (19.249) 18.39  (30.324) 25.64  (33.758) 19.61  (23.743) 28.57  (23.003)
Financial impact symptom scale (CFB) Number Analyzed 2 participants 0 participants 3 participants 1 participants 19 participants 8 participants 12 participants 5 participants
16.67  (23.568) -11.11  (19.243) 0 [1]   (NA) -1.75  (25.996) -12.50  (24.801) -5.56  (12.976) 20  (18.259)
[1]
Standard deviation was not calculated due to insufficient number of participants.
Time Frame From start of study drug administration up to approximately 21 months
Adverse Event Reporting Description The Medicines and Healthcare Products Regulatory Agency (MHRA) identified data integrity issues and deficiencies for AEs/SAEs for non-Shire investigational medicinal products IMPs. Per the Sponsor assessment, there was no impact of the initial non-assessment of absence of causality for SAEs associated with non-Shire IMPs (that, apart from BAX069/imalumab) on patient safety within the study, integrity of the safety conclusion or on the post-marketing safety profile for any of the non-Shire IMPs.
 
Arm/Group Title Part 1: Imalumab 7.5 mg/kg + 5-FU/LV Part 1: Imalumab 7.5 mg/kg + Panitumumab Part 1: Imalumab 10 mg/kg + 5-FU/LV Part 1: Imalumab 10 mg/kg + Panitumumab Part 2: Imalumab 10 mg/kg + 5-FU/LV Part 2: Standard of Care Mutant Part 2: Imalumab 10 mg/kg + Panitumumab Part 2: Standard of Care Wild Type
Hide Arm/Group Description Participants with mutated tumors (KRAS mut, NRAS mut) received 7.5 mg/kg dose of imalumab QW in combination with 5- FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) for Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. Participants with wild-type tumors (KRAS wt, NRAS wt) received 7.5 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. Participants with mutated tumors (KRAS mut, NRAS mut) received 10 mg/kg dose of imalumab as a recommended phase 2 dose (RP2D) QW in combination with 5-FU/LV (LV 400 mg/m^2 IV infusion over 2 hours, followed by 5 FU 2400 mg/m^2 IV infusion over 46 hours) Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. Participants with mutated tumors (KRAS mut, NRAS mut) received standard of care (SoC) as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. Participants with wild-type tumors (KRAS wt, NRAS wt) received 10 mg/kg dose of imalumab as a RP2D QW in combination with panitumumab 6 mg/kg Q2W IV infusion as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first. Participants with wild-type tumors (KRAS wt, NRAS wt) received SoC as chosen by the investigator and was administered in accordance to product label as a part of 4-week/28-day treatment cycle and continued until disease progression, unacceptable toxicity, death, or participant withdrawal of consent, whichever occurred first.
All-Cause Mortality
Part 1: Imalumab 7.5 mg/kg + 5-FU/LV Part 1: Imalumab 7.5 mg/kg + Panitumumab Part 1: Imalumab 10 mg/kg + 5-FU/LV Part 1: Imalumab 10 mg/kg + Panitumumab Part 2: Imalumab 10 mg/kg + 5-FU/LV Part 2: Standard of Care Mutant Part 2: Imalumab 10 mg/kg + Panitumumab Part 2: Standard of Care Wild Type
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   1/3 (33.33%)      0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      10/29 (34.48%)      7/13 (53.85%)      4/18 (22.22%)      2/7 (28.57%)    
Hide Serious Adverse Events
Part 1: Imalumab 7.5 mg/kg + 5-FU/LV Part 1: Imalumab 7.5 mg/kg + Panitumumab Part 1: Imalumab 10 mg/kg + 5-FU/LV Part 1: Imalumab 10 mg/kg + Panitumumab Part 2: Imalumab 10 mg/kg + 5-FU/LV Part 2: Standard of Care Mutant Part 2: Imalumab 10 mg/kg + Panitumumab Part 2: Standard of Care Wild Type
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   1/3 (33.33%)      1/3 (33.33%)      1/3 (33.33%)      2/3 (66.67%)      15/29 (51.72%)      8/13 (61.54%)      7/18 (38.89%)      2/7 (28.57%)    
Blood and lymphatic system disorders                 
Anaemia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Neutropenia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Cardiac disorders                 
Atrial fibrillation * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Gastrointestinal disorders                 
Abdominal pain * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Ascites * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 1/13 (7.69%)  1 0/18 (0.00%)  0 0/7 (0.00%)  0
Diarrhoea * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Intestinal obstruction * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Large intestinal obstruction * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Rectal haemorrhage * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Small intestinal obstruction * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  3 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 1/7 (14.29%)  1
General disorders                 
Disease progression * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 8/29 (27.59%)  8 3/13 (23.08%)  3 1/18 (5.56%)  1 1/7 (14.29%)  1
General physical health deterioration * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Multiple organ dysfunction syndrome * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 1/13 (7.69%)  1 0/18 (0.00%)  0 0/7 (0.00%)  0
Pyrexia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Hepatobiliary disorders                 
Gallbladder pain * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Hepatic failure * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 2/13 (15.38%)  2 0/18 (0.00%)  0 0/7 (0.00%)  0
Hyperbilirubinaemia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Infections and infestations                 
Perineal abscess * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 1/13 (7.69%)  1 0/18 (0.00%)  0 0/7 (0.00%)  0
Rectal abscess * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Injury, poisoning and procedural complications                 
Femoral neck fracture * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Infusion related reaction * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Investigations                 
Blood bilirubin increased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 1/13 (7.69%)  1 0/18 (0.00%)  0 0/7 (0.00%)  0
Metabolism and nutrition disorders                 
Dehydration * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 1/13 (7.69%)  1 0/18 (0.00%)  0 0/7 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Malignant neoplasm progression * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/29 (6.90%)  2 2/13 (15.38%)  3 2/18 (11.11%)  2 1/7 (14.29%)  1
Rectal cancer metastatic * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 2/13 (15.38%)  2 0/18 (0.00%)  0 0/7 (0.00%)  0
Nervous system disorders                 
Hepatic encephalopathy * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 1/13 (7.69%)  1 0/18 (0.00%)  0 0/7 (0.00%)  0
Syncope * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                 
Haemoptysis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  2 0/7 (0.00%)  0
Pulmonary embolism * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Respiratory failure * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part 1: Imalumab 7.5 mg/kg + 5-FU/LV Part 1: Imalumab 7.5 mg/kg + Panitumumab Part 1: Imalumab 10 mg/kg + 5-FU/LV Part 1: Imalumab 10 mg/kg + Panitumumab Part 2: Imalumab 10 mg/kg + 5-FU/LV Part 2: Standard of Care Mutant Part 2: Imalumab 10 mg/kg + Panitumumab Part 2: Standard of Care Wild Type
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   2/3 (66.67%)      3/3 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      28/29 (96.55%)      12/13 (92.31%)      17/18 (94.44%)      7/7 (100.00%)    
Blood and lymphatic system disorders                 
Anaemia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 5/29 (17.24%)  11 3/13 (23.08%)  3 1/18 (5.56%)  1 0/7 (0.00%)  0
Coagulopathy * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Neutropenia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 1/13 (7.69%)  4 0/18 (0.00%)  0 0/7 (0.00%)  0
Thrombocytopenia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 1/13 (7.69%)  1 0/18 (0.00%)  0 0/7 (0.00%)  0
Cardiac disorders                 
Tachycardia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 1/13 (7.69%)  1 0/18 (0.00%)  0 0/7 (0.00%)  0
Congenital, familial and genetic disorders                 
Dermoid cyst * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  2 0/7 (0.00%)  0
Eye disorders                 
Blepharitis * 1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Dry eye * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 2/18 (11.11%)  2 0/7 (0.00%)  0
Episcleritis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Lacrimation increased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Gastrointestinal disorders                 
Abdominal discomfort * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 2/18 (11.11%)  2 0/7 (0.00%)  0
Abdominal distension * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 1/13 (7.69%)  1 1/18 (5.56%)  1 1/7 (14.29%)  1
Abdominal pain * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 7/29 (24.14%)  8 4/13 (30.77%)  4 1/18 (5.56%)  1 3/7 (42.86%)  4
Abdominal pain upper * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 2/13 (15.38%)  2 2/18 (11.11%)  4 0/7 (0.00%)  0
Abdominal rigidity * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Constipation * 1  0/3 (0.00%)  0 1/3 (33.33%)  2 1/3 (33.33%)  1 0/3 (0.00%)  0 9/29 (31.03%)  9 4/13 (30.77%)  4 3/18 (16.67%)  7 1/7 (14.29%)  1
Diarrhoea * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 8/29 (27.59%)  10 5/13 (38.46%)  11 5/18 (27.78%)  6 1/7 (14.29%)  2
Dyspepsia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 3/29 (10.34%)  3 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Flatulence * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Haematochezia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Haemorrhoids * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 1/13 (7.69%)  1 1/18 (5.56%)  1 0/7 (0.00%)  0
Nausea * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 9/29 (31.03%)  13 5/13 (38.46%)  7 4/18 (22.22%)  9 1/7 (14.29%)  2
Oral dysaesthesia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Proctalgia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 0/13 (0.00%)  0 1/18 (5.56%)  2 0/7 (0.00%)  0
Rectal haemorrhage * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  2 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Stomatitis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 4/29 (13.79%)  8 1/13 (7.69%)  1 1/18 (5.56%)  1 1/7 (14.29%)  1
Tongue ulceration * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Vomiting * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  2 0/3 (0.00%)  0 8/29 (27.59%)  9 2/13 (15.38%)  3 2/18 (11.11%)  3 0/7 (0.00%)  0
General disorders                 
Asthenia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 6/29 (20.69%)  13 3/13 (23.08%)  5 1/18 (5.56%)  1 1/7 (14.29%)  1
Chest pain * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/29 (6.90%)  2 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Chills * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/29 (6.90%)  2 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Early satiety * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 1/13 (7.69%)  1 0/18 (0.00%)  0 0/7 (0.00%)  0
Fatigue * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 16/29 (55.17%)  28 4/13 (30.77%)  11 5/18 (27.78%)  6 5/7 (71.43%)  8
Hypothermia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Inflammation * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 1/13 (7.69%)  1 0/18 (0.00%)  0 0/7 (0.00%)  0
Localised oedema * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 1/13 (7.69%)  1 0/18 (0.00%)  0 0/7 (0.00%)  0
Malaise * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 1/13 (7.69%)  1 0/18 (0.00%)  0 1/7 (14.29%)  1
Mucosal inflammation * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 9/29 (31.03%)  18 1/13 (7.69%)  2 1/18 (5.56%)  2 1/7 (14.29%)  1
Oedema peripheral * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 3/29 (10.34%)  3 1/13 (7.69%)  1 0/18 (0.00%)  0 0/7 (0.00%)  0
Pyrexia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/29 (6.90%)  2 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Temperature intolerance * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Infections and infestations                 
Conjunctivitis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Genital herpes * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 1/13 (7.69%)  1 0/18 (0.00%)  0 0/7 (0.00%)  0
Herpes zoster * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 1/13 (7.69%)  1 0/18 (0.00%)  0 0/7 (0.00%)  0
Localised infection * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Lymph gland infection * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Oral herpes * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Paronychia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 4/18 (22.22%)  6 0/7 (0.00%)  0
Rash pustular * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Urinary tract infection * 1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/3 (0.00%)  0 1/3 (33.33%)  1 1/29 (3.45%)  1 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Viral upper respiratory tract infection * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 1/13 (7.69%)  1 1/18 (5.56%)  2 0/7 (0.00%)  0
Injury, poisoning and procedural complications                 
Contusion * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Laceration * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Scratch * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Venomous sting * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Investigations                 
Alanine aminotransferase increased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  2 2/13 (15.38%)  8 0/18 (0.00%)  0 1/7 (14.29%)  1
Aspartate aminotransferase increased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/29 (6.90%)  2 2/13 (15.38%)  6 0/18 (0.00%)  0 1/7 (14.29%)  1
Blood albumin increased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Blood alkaline phosphatase increased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Blood bilirubin increased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 2/29 (6.90%)  4 2/13 (15.38%)  2 1/18 (5.56%)  1 0/7 (0.00%)  0
Blood creatinine increased * 1  1/3 (33.33%)  4 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Lymphocyte count decreased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 2/13 (15.38%)  3 0/18 (0.00%)  0 0/7 (0.00%)  0
Neutrophil count decreased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 3/13 (23.08%)  16 0/18 (0.00%)  0 1/7 (14.29%)  1
Platelet count decreased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 1/13 (7.69%)  1 0/18 (0.00%)  0 1/7 (14.29%)  1
Weight decreased * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 2/3 (66.67%)  2 1/3 (33.33%)  1 0/29 (0.00%)  0 2/13 (15.38%)  2 1/18 (5.56%)  1 0/7 (0.00%)  0
White blood cell count decreased * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 1/13 (7.69%)  13 0/18 (0.00%)  0 0/7 (0.00%)  0
Metabolism and nutrition disorders                 
Decreased appetite * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 6/29 (20.69%)  10 5/13 (38.46%)  6 2/18 (11.11%)  2 2/7 (28.57%)  3
Dehydration * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 1/29 (3.45%)  1 2/13 (15.38%)  3 0/18 (0.00%)  0 0/7 (0.00%)  0
Hyperkalaemia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 1/13 (7.69%)  1 0/18 (0.00%)  0 0/7 (0.00%)  0
Hypocalcaemia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Hypokalaemia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/29 (0.00%)  0 2/13 (15.38%)  2 2/18 (11.11%)  2 1/7 (14.29%)  1
Hypomagnesaemia * 1  1/3 (33.33%)  1 1/3 (33.33%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 3/18 (16.67%)  3 0/7 (0.00%)  0
Iron deficiency * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 1/13 (7.69%)  1 0/18 (0.00%)  0 0/7 (0.00%)  0
Musculoskeletal and connective tissue disorders                 
Arthralgia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  3 1/7 (14.29%)  2
Back pain * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 4/29 (13.79%)  6 3/13 (23.08%)  3 0/18 (0.00%)  0 1/7 (14.29%)  2
Bone pain * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 1/13 (7.69%)  1 0/18 (0.00%)  0 0/7 (0.00%)  0
Flank pain * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 0/13 (0.00%)  0 1/18 (5.56%)  2 1/7 (14.29%)  2
Joint swelling * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Muscular weakness * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 2/13 (15.38%)  2 0/18 (0.00%)  0 0/7 (0.00%)  0
Musculoskeletal chest pain * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Musculoskeletal pain * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 3/29 (10.34%)  4 0/13 (0.00%)  0 1/18 (5.56%)  1 1/7 (14.29%)  1
Musculoskeletal stiffness * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Myalgia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 1/13 (7.69%)  1 0/18 (0.00%)  0 0/7 (0.00%)  0
Pain in extremity * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 2/29 (6.90%)  3 1/13 (7.69%)  1 0/18 (0.00%)  0 0/7 (0.00%)  0
Nervous system disorders                 
Dizziness * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Headache * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  2 1/13 (7.69%)  1 2/18 (11.11%)  2 0/7 (0.00%)  0
Migraine * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  3 0/7 (0.00%)  0
Neuralgia * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Neuropathy peripheral * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 1/7 (14.29%)  1
Paraesthesia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 1/13 (7.69%)  6 0/18 (0.00%)  0 0/7 (0.00%)  0
Parosmia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Restless legs syndrome * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Somnolence * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Psychiatric disorders                 
Anxiety * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 1/13 (7.69%)  2 2/18 (11.11%)  2 0/7 (0.00%)  0
Depression * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/29 (6.90%)  2 0/13 (0.00%)  0 2/18 (11.11%)  2 0/7 (0.00%)  0
Insomnia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/29 (6.90%)  3 1/13 (7.69%)  3 1/18 (5.56%)  1 0/7 (0.00%)  0
Renal and urinary disorders                 
Chromaturia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 1/7 (14.29%)  1
Dysuria * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 1/7 (14.29%)  1
Haematuria * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Micturition urgency * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Proteinuria * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 1/13 (7.69%)  1 0/18 (0.00%)  0 0/7 (0.00%)  0
Urinary retention * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Reproductive system and breast disorders                 
Menorrhagia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 1/7 (14.29%)  2
Pelvic pain * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 0/13 (0.00%)  0 1/18 (5.56%)  2 0/7 (0.00%)  0
Prostatitis * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Scrotal disorder * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Sexual dysfunction * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Vaginal haemorrhage * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 1/13 (7.69%)  1 0/18 (0.00%)  0 0/7 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                 
Cough * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  2 2/29 (6.90%)  2 1/13 (7.69%)  1 3/18 (16.67%)  3 1/7 (14.29%)  1
Dyspnoea * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 4/29 (13.79%)  5 1/13 (7.69%)  1 3/18 (16.67%)  4 0/7 (0.00%)  0
Dyspnoea exertional * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 1/7 (14.29%)  1
Epistaxis * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 2/29 (6.90%)  2 0/13 (0.00%)  0 2/18 (11.11%)  3 0/7 (0.00%)  0
Nasal congestion * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Oropharyngeal pain * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 1/13 (7.69%)  1 1/18 (5.56%)  1 0/7 (0.00%)  0
Rhinorrhoea * 1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Throat irritation * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Upper-Airway cough syndrome * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Skin and subcutaneous tissue disorders                 
Acne * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 1/7 (14.29%)  1
Alopecia * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 1/7 (14.29%)  1
Blister * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Dermatitis acneiform * 1  0/3 (0.00%)  0 1/3 (33.33%)  3 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 8/18 (44.44%)  22 2/7 (28.57%)  4
Dermatitis contact * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Dry skin * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 0/29 (0.00%)  0 1/13 (7.69%)  2 6/18 (33.33%)  6 1/7 (14.29%)  1
Nail discolouration * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 1/7 (14.29%)  2
Nail discomfort * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 1/7 (14.29%)  2
Nail disorder * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Night sweats * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  2 0/7 (0.00%)  0
Palmar-Plantar erythrodysaesthesia syndrome * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 1/13 (7.69%)  4 0/18 (0.00%)  0 1/7 (14.29%)  1
Pruritus * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 4/18 (22.22%)  5 1/7 (14.29%)  3
Rash * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1 0/13 (0.00%)  0 9/18 (50.00%)  18 0/7 (0.00%)  0
Rash erythematous * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Rash generalised * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Rash maculo-papular * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 1/7 (14.29%)  1
Rash papular * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 0/18 (0.00%)  0 0/7 (0.00%)  0
Skin fissures * 1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 3/18 (16.67%)  9 1/7 (14.29%)  1
Skin ulcer * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Trichorrhexis * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Vascular disorders                 
Hot flush * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/29 (0.00%)  0 0/13 (0.00%)  0 1/18 (5.56%)  1 0/7 (0.00%)  0
Hypertension * 1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/29 (0.00%)  0 2/13 (15.38%)  6 0/18 (0.00%)  0 1/7 (14.29%)  1
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
On 2016 DEC 16, the data safety monitoring board (DSMB) reviewed the periodic safety data, and in addition also reviewed available efficacy data from the first 33 PFS events and non-clinical information and recommended to terminate Study 391401.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Physician
Organization: Baxalta, now part of Shire
Phone: 1 866 842 5335
EMail: ClinicalTransparency@shire.com
Layout table for additonal information
Responsible Party: Shire ( Baxalta now part of Shire )
ClinicalTrials.gov Identifier: NCT02448810    
Other Study ID Numbers: 391401
2015-000896-28 ( EudraCT Number )
First Submitted: May 15, 2015
First Posted: May 20, 2015
Results First Submitted: February 15, 2018
Results First Posted: March 19, 2018
Last Update Posted: November 4, 2019