Trial Outcomes & Findings for A Study of IMC-1121B (Ramucirumab) With or Without Dacarbazine in Metastatic Malignant Melanoma (NCT NCT00533702)
NCT ID: NCT00533702
Last Updated: 2014-08-01
Results Overview
PFS was defined as the time from the first day of therapy to the first evidence of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter (LD) of the target lesions, taking as reference the smallest sum LD recorded since the treatment started in comparison with the measurement of the nadir or the appearance of 1 or more new lesions. In addition, unequivocal progression of existing non-target lesions was considered PD. New or existing pleural effusion/ascites required cytological confirmation for PD according to the protocol. Participants who did not progress and who were alive or did not have documented progression or missed ≥2 visits, or had no post baseline assessment were censored at the day of their last tumor assessment.
COMPLETED
PHASE2
106 participants
Baseline up to 36 months
2014-08-01
Participant Flow
Participants who completed the study were those who died or were alive but off treatment at the end of the study.
Participant milestones
| Measure |
IMC-1121B (Ramucirumab) + Dacarbazine
IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
|
IMC-1121B (Ramucirumab)
IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
52
|
|
Overall Study
Received Any Quantity of Study Drug
|
52
|
50
|
|
Overall Study
COMPLETED
|
49
|
50
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
IMC-1121B (Ramucirumab) + Dacarbazine
IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
|
IMC-1121B (Ramucirumab)
IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Found ineligible after randomization
|
2
|
1
|
Baseline Characteristics
A Study of IMC-1121B (Ramucirumab) With or Without Dacarbazine in Metastatic Malignant Melanoma
Baseline characteristics by cohort
| Measure |
IMC-1121B (Ramucirumab) + Dacarbazine
n=52 Participants
IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
|
IMC-1121B (Ramucirumab)
n=50 Participants
IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
50 participants
n=7 Participants
|
102 participants
n=5 Participants
|
|
Race
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race
White
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Race
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 36 monthsPopulation: Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug. Censored participants: IMC-1121B (ramucirumab) + dacarbazine=9; IMC-1121B (ramucirumab)=4.
PFS was defined as the time from the first day of therapy to the first evidence of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter (LD) of the target lesions, taking as reference the smallest sum LD recorded since the treatment started in comparison with the measurement of the nadir or the appearance of 1 or more new lesions. In addition, unequivocal progression of existing non-target lesions was considered PD. New or existing pleural effusion/ascites required cytological confirmation for PD according to the protocol. Participants who did not progress and who were alive or did not have documented progression or missed ≥2 visits, or had no post baseline assessment were censored at the day of their last tumor assessment.
Outcome measures
| Measure |
IMC-1121B (Ramucirumab) + Dacarbazine
n=52 Participants
IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
|
IMC-1121B (Ramucirumab)
n=50 Participants
IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
2.6 months
Interval 1.4 to 5.4
|
1.7 months
Interval 1.4 to 2.9
|
SECONDARY outcome
Timeframe: Baseline up to 40 monthsPopulation: Safety Population: All enrolled participants who were treated with any quantity of study drug.
The number of participants who experienced any IMC-1121B (ramucirumab \[RAM\]) treatment-related and treatment emergent AE (TEAE), treatment-related TEAE of Grade ≥3, treatment-related TE serious AEs (SAEs), treatment-related TEAE resulting in death (Grade 5 AE) and any TEAEs resulting in death. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
IMC-1121B (Ramucirumab) + Dacarbazine
n=52 Participants
IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
|
IMC-1121B (Ramucirumab)
n=50 Participants
IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
|
|---|---|---|
|
Number of Participants With Adverse Events (AE)
Any RAM related TEAE
|
43 participants
|
40 participants
|
|
Number of Participants With Adverse Events (AE)
RAM related SAE
|
9 participants
|
5 participants
|
|
Number of Participants With Adverse Events (AE)
RAM related ≥ Grade 3 AE
|
20 participants
|
13 participants
|
|
Number of Participants With Adverse Events (AE)
RAM related death
|
1 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AE)
Any AE with outcome of death
|
2 participants
|
2 participants
|
|
Number of Participants With Adverse Events (AE)
RAM related TEAE leading to discontinuation of RAM
|
3 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (of 21-day cycle) up to 17.1 monthsPopulation: Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug.
The ORR was defined as the percentage of all randomized participants with the best overall response of PR or CR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met.
Outcome measures
| Measure |
IMC-1121B (Ramucirumab) + Dacarbazine
n=52 Participants
IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
|
IMC-1121B (Ramucirumab)
n=50 Participants
IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
|
|---|---|---|
|
Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]
|
17.3 percentage of participants
Interval 8.2 to 30.3
|
4.0 percentage of participants
Interval 0.5 to 13.7
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (of 21-day cycle) up to 17.1 monthsPopulation: Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug and who had CR or PR. Censored participants: IMC-1121B (ramucirumab) + dacarbazine=2; IMC-1121B (ramucirumab)=0.
The duration of overall response was defined as the time from first assessment of complete response (CR) or partial response (PR) to the first date of progressive disease (PD) using Response Evaluation Criteria in Solid Tumors (RECIST v1.0), initiation of other or additional antitumor therapy, or death from any cause. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met. PD was defined as at least 20% increase in sum of longest diameter of target lesions. Participants who did not relapse were censored at the day of their last objective tumor assessment.
Outcome measures
| Measure |
IMC-1121B (Ramucirumab) + Dacarbazine
n=9 Participants
IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
|
IMC-1121B (Ramucirumab)
n=2 Participants
IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
|
|---|---|---|
|
Duration of Response
|
11.0 months
Interval 3.9 to 17.1
|
NA months
Interval 3.2 to 14.0
Median was not calculated since there are only 2 data points.
|
SECONDARY outcome
Timeframe: 6 weeks (2 cycles of treatment)Population: Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug.
Disease Control Rate (DCR) was defined as complete response (CR) plus partial response (PR) plus SD using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions and the normalization of non-target lesion tumor marker levels. PR was defined as at least a 30% decrease from baseline in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met. SD was defined as: neither sufficient increase to qualify for progressive disease (PD) nor sufficient shrinkage to qualify for PR, taking as reference the smallest sum of the longest diameters recorded since treatment began. PD was defined as at least 20% increase in sum of longest diameter of target lesions.
Outcome measures
| Measure |
IMC-1121B (Ramucirumab) + Dacarbazine
n=52 Participants
IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
|
IMC-1121B (Ramucirumab)
n=50 Participants
IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
|
|---|---|---|
|
Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 6 Weeks
|
54 percentage of participants
|
44 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeks (4 cycles of treatment)Population: Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug.
Disease Control Rate (DCR) was defined as complete response (CR) plus partial response (PR) plus SD using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions and the normalization of non-target lesion tumor marker levels. PR was defined as at least a 30% decrease from baseline in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met. Stable Disease (SD) was defined as: neither sufficient increase to qualify for progressive disease (PD) nor sufficient shrinkage to qualify for PR, taking as reference the smallest sum of the longest diameters recorded since treatment began. PD was defined as at least 20% increase in sum of longest diameter of target lesions.
Outcome measures
| Measure |
IMC-1121B (Ramucirumab) + Dacarbazine
n=52 Participants
IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
|
IMC-1121B (Ramucirumab)
n=50 Participants
IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
|
|---|---|---|
|
Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 12 Weeks
|
40 percentage of participants
|
24 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeks (4 cycles of treatment)Population: Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug.
Response rate was defined as a CR or a PR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions and the normalization of non-target lesion tumor marker levels. PR was defined as at least a 30% decrease from baseline in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met.
Outcome measures
| Measure |
IMC-1121B (Ramucirumab) + Dacarbazine
n=52 Participants
IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
|
IMC-1121B (Ramucirumab)
n=50 Participants
IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
|
|---|---|---|
|
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate) at 12 Weeks
|
13.5 percentage of participants
|
4.0 percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (21-day cycle) 1-hour post infusionPopulation: Zero participants were analyzed.
Cmax was not calculated due to sparse sampling.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 Day 7 (21-day cycle)Population: Zero participants were analyzed.
Cmax was not calculated due to sparse sampling.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 Day 14 (21-day cycle)Population: Zero participants were analyzed.
Cmax was not calculated due to sparse sampling.
Outcome measures
Outcome data not reported
Adverse Events
IMC-1121B (Ramucirumab) + Dacarbazine
IMC-1121B (Ramucirumab)
Serious adverse events
| Measure |
IMC-1121B (Ramucirumab) + Dacarbazine
n=52 participants at risk
IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
|
IMC-1121B (Ramucirumab)
n=50 participants at risk
IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Cardiac disorders
Cardiac arrest
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/52
|
4.0%
2/50 • Number of events 2
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Gastrointestinal disorders
Proctalgia
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
General disorders
Chest pain
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
General disorders
Infusion related reaction
|
0.00%
0/52
|
6.0%
3/50 • Number of events 3
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/52
|
4.0%
2/50 • Number of events 3
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Diverticulitis
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Infections and infestations
Infection
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Infections and infestations
Pneumonia
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Nervous system disorders
Convulsion
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Nervous system disorders
Syncope
|
1.9%
1/52 • Number of events 1
|
2.0%
1/50 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Vascular disorders
Flushing
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Vascular disorders
Hypertension
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
|
Vascular disorders
Hypotension
|
0.00%
0/52
|
2.0%
1/50 • Number of events 1
|
|
Vascular disorders
Pelvic venous thrombosis
|
1.9%
1/52 • Number of events 1
|
0.00%
0/50
|
Other adverse events
| Measure |
IMC-1121B (Ramucirumab) + Dacarbazine
n=52 participants at risk
IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
|
IMC-1121B (Ramucirumab)
n=50 participants at risk
IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
13.5%
7/52 • Number of events 22
|
4.0%
2/50 • Number of events 4
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.6%
5/52 • Number of events 15
|
2.0%
1/50 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
34.6%
18/52 • Number of events 29
|
0.00%
0/50
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
38.5%
20/52 • Number of events 54
|
8.0%
4/50 • Number of events 7
|
|
Eye disorders
Vision blurred
|
1.9%
1/52 • Number of events 1
|
6.0%
3/50 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal pain
|
9.6%
5/52 • Number of events 6
|
12.0%
6/50 • Number of events 6
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.8%
3/52 • Number of events 3
|
4.0%
2/50 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
30.8%
16/52 • Number of events 23
|
20.0%
10/50 • Number of events 10
|
|
Gastrointestinal disorders
Diarrhoea
|
19.2%
10/52 • Number of events 13
|
16.0%
8/50 • Number of events 10
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
4/52 • Number of events 5
|
0.00%
0/50
|
|
Gastrointestinal disorders
Dyspepsia
|
3.8%
2/52 • Number of events 2
|
6.0%
3/50 • Number of events 3
|
|
Gastrointestinal disorders
Gingival bleeding
|
5.8%
3/52 • Number of events 3
|
8.0%
4/50 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
38.5%
20/52 • Number of events 36
|
28.0%
14/50 • Number of events 19
|
|
Gastrointestinal disorders
Vomiting
|
13.5%
7/52 • Number of events 9
|
22.0%
11/50 • Number of events 12
|
|
General disorders
Chest pain
|
5.8%
3/52 • Number of events 3
|
4.0%
2/50 • Number of events 2
|
|
General disorders
Chills
|
11.5%
6/52 • Number of events 7
|
16.0%
8/50 • Number of events 8
|
|
General disorders
Fatigue
|
63.5%
33/52 • Number of events 63
|
56.0%
28/50 • Number of events 38
|
|
General disorders
Infusion related reaction
|
7.7%
4/52 • Number of events 4
|
8.0%
4/50 • Number of events 5
|
|
General disorders
Infusion site pain
|
5.8%
3/52 • Number of events 3
|
0.00%
0/50
|
|
General disorders
Injection site irritation
|
7.7%
4/52 • Number of events 8
|
0.00%
0/50
|
|
General disorders
Oedema peripheral
|
28.8%
15/52 • Number of events 27
|
20.0%
10/50 • Number of events 12
|
|
General disorders
Pain
|
7.7%
4/52 • Number of events 4
|
4.0%
2/50 • Number of events 2
|
|
General disorders
Pyrexia
|
3.8%
2/52 • Number of events 3
|
16.0%
8/50 • Number of events 8
|
|
Infections and infestations
Upper respiratory tract infection
|
11.5%
6/52 • Number of events 7
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Weight decreased
|
3.8%
2/52 • Number of events 2
|
10.0%
5/50 • Number of events 12
|
|
Metabolism and nutrition disorders
Anorexia
|
26.9%
14/52 • Number of events 15
|
14.0%
7/50 • Number of events 8
|
|
Metabolism and nutrition disorders
Dehydration
|
9.6%
5/52 • Number of events 5
|
6.0%
3/50 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.8%
3/52 • Number of events 5
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.6%
5/52 • Number of events 6
|
12.0%
6/50 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.3%
9/52 • Number of events 10
|
18.0%
9/50 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.7%
4/52 • Number of events 5
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.8%
3/52 • Number of events 3
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.7%
4/52 • Number of events 7
|
4.0%
2/50 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.7%
4/52 • Number of events 7
|
6.0%
3/50 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.5%
6/52 • Number of events 7
|
4.0%
2/50 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
5.8%
3/52 • Number of events 5
|
4.0%
2/50 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
9.6%
5/52 • Number of events 6
|
6.0%
3/50 • Number of events 3
|
|
Nervous system disorders
Headache
|
17.3%
9/52 • Number of events 18
|
32.0%
16/50 • Number of events 21
|
|
Nervous system disorders
Paraesthesia
|
1.9%
1/52 • Number of events 1
|
6.0%
3/50 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
9.6%
5/52 • Number of events 6
|
8.0%
4/50 • Number of events 4
|
|
Psychiatric disorders
Depression
|
7.7%
4/52 • Number of events 4
|
8.0%
4/50 • Number of events 4
|
|
Psychiatric disorders
Insomnia
|
17.3%
9/52 • Number of events 9
|
10.0%
5/50 • Number of events 5
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/52
|
8.0%
4/50 • Number of events 5
|
|
Renal and urinary disorders
Proteinuria
|
7.7%
4/52 • Number of events 8
|
12.0%
6/50 • Number of events 17
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.5%
6/52 • Number of events 8
|
10.0%
5/50 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.8%
3/52 • Number of events 3
|
4.0%
2/50 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
26.9%
14/52 • Number of events 16
|
8.0%
4/50 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.8%
3/52 • Number of events 3
|
6.0%
3/50 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.5%
7/52 • Number of events 12
|
8.0%
4/50 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.8%
3/52 • Number of events 3
|
0.00%
0/50
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.8%
3/52 • Number of events 6
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.8%
2/52 • Number of events 2
|
6.0%
3/50 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.8%
3/52 • Number of events 5
|
2.0%
1/50 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.8%
3/52 • Number of events 3
|
8.0%
4/50 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.7%
4/52 • Number of events 5
|
6.0%
3/50 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.8%
3/52 • Number of events 5
|
2.0%
1/50 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.5%
6/52 • Number of events 10
|
8.0%
4/50 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.4%
8/52 • Number of events 12
|
16.0%
8/50 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
5.8%
3/52 • Number of events 3
|
0.00%
0/50
|
|
Vascular disorders
Flushing
|
5.8%
3/52 • Number of events 3
|
2.0%
1/50 • Number of events 1
|
|
Vascular disorders
Hypertension
|
23.1%
12/52 • Number of events 18
|
24.0%
12/50 • Number of events 19
|
Additional Information
Chief Medical Officer
Eli Lilly and company
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER