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| ID | Type | Description | Link |
|---|---|---|---|
| CP12-0604 | Other Identifier | ImClone Systems | |
| I4T-IE-JVBO | Other Identifier | Eli Lilly and Company |
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The primary objective of this study is to determine the progression-free survival (PFS) of participants with previously untreated metastatic malignant melanoma when treated with IMC-1121B (ramucirumab) alone or in combination with dacarbazine.
The purpose of this study is to determine the antitumor activity and safety profile of IMC-1121B (ramucirumab) when used alone or in combination with dacarbazine in participants with metastatic melanoma who have not received prior chemotherapy for this disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMC-1121B (ramucirumab) | Experimental | IMC-1121B (ramucirumab) |
|
| IMC-1121B (ramucirumab) + dacarbazine | Active Comparator | IMC-1121B (ramucirumab) + dacarbazine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMC-1121B (ramucirumab) | Biological | 10 milligrams/kilogram (mg/kg) intravenously every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | 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. | Baseline up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AE) | 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. |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ImClone Investigational Site | Decatur | Alabama | 35601 | United States | ||
| ImClone Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24930625 | Derived | Carvajal RD, Wong MK, Thompson JA, Gordon MS, Lewis KD, Pavlick AC, Wolchok JD, Rojas PB, Schwartz JD, Bedikian AY. A phase 2 randomised study of ramucirumab (IMC-1121B) with or without dacarbazine in patients with metastatic melanoma. Eur J Cancer. 2014 Aug;50(12):2099-107. doi: 10.1016/j.ejca.2014.03.289. Epub 2014 Jun 12. |
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Participants who completed the study were those who died or were alive but off treatment at the end of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Dacarbazine | Drug | 1000 milligrams/square meter (mg/m2) intravenously every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria. |
|
|
| Baseline up to 40 months |
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] | 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. | Cycle 1 Day 1 (of 21-day cycle) up to 17.1 months |
| Duration of Response | 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. | Cycle 1 Day 1 (of 21-day cycle) up to 17.1 months |
| Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 6 Weeks | 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. | 6 weeks (2 cycles of treatment) |
| Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 12 Weeks | 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. | 12 weeks (4 cycles of treatment) |
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate) at 12 Weeks | 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. | 12 weeks (4 cycles of treatment) |
| Maximum Concentration (Cmax) for Cycle 1 Day 1 | Cmax was not calculated due to sparse sampling. | Cycle 1 Day 1 (21-day cycle) 1-hour post infusion |
| Maximum Concentration (Cmax) for Cycle 1 Day 7 | Cmax was not calculated due to sparse sampling. | Cycle 1 Day 7 (21-day cycle) |
| Maximum Concentration (Cmax) for Cycle 1 Day 14 | Cmax was not calculated due to sparse sampling. | Cycle 1 Day 14 (21-day cycle) |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| ImClone Investigational Site | Scottsdale | Arizona | 85260 | United States |
| ImClone Investigational Site | Fresno | California | 93720 | United States |
| ImClone Investigational Site | San Francisco | California | 94109 | United States |
| ImClone Investigational Site | Aurora | Colorado | 80045 | United States |
| ImClone Investigational Site | Jacksonville | Florida | 32256 | United States |
| ImClone Investigational Site | Orlando | Florida | 32806 | United States |
| ImClone Investigational Site | Oxford | Mississippi | 38655 | United States |
| ImClone Investigational Site | Missoula | Montana | 59806 | United States |
| ImClone Investigational Site | Buffalo | New York | 14263 | United States |
| ImClone Investigational Site | New York | New York | 10016 | United States |
| ImClone Investigational Site | New York | New York | 10021 | United States |
| ImClone Investigational Site | Willow Grove | Pennsylvania | 19090 | United States |
| ImClone Investigational Site | Dallas | Texas | 75230 | United States |
| ImClone Investigational Site | Houston | Texas | 77030 | United States |
| ImClone Investigational Site | Seattle | Washington | 98109 | United States |
| FG001 | 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. |
| Received Any Quantity of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All enrolled participants who were treated with any quantity of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Race | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) | 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. | 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. | Posted | Median | 95% Confidence Interval | months | Baseline up to 36 months |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AE) | 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. | Safety Population: All enrolled participants who were treated with any quantity of study drug. | Posted | Number | participants | Baseline up to 40 months |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] | 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. | Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Cycle 1 Day 1 (of 21-day cycle) up to 17.1 months |
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Response | 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. | 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. | Posted | Median | 95% Confidence Interval | months | Cycle 1 Day 1 (of 21-day cycle) up to 17.1 months |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 6 Weeks | 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. | Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug. | Posted | Number | percentage of participants | 6 weeks (2 cycles of treatment) |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 12 Weeks | 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. | Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug. | Posted | Number | percentage of participants | 12 weeks (4 cycles of treatment) |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate) at 12 Weeks | 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. | Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug. | Posted | Number | percentage of participants | 12 weeks (4 cycles of treatment) |
| |||||||||||||||||||||||||||||||
| Secondary | Maximum Concentration (Cmax) for Cycle 1 Day 1 | Cmax was not calculated due to sparse sampling. | Zero participants were analyzed. | Posted | Cycle 1 Day 1 (21-day cycle) 1-hour post infusion |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Maximum Concentration (Cmax) for Cycle 1 Day 7 | Cmax was not calculated due to sparse sampling. | Zero participants were analyzed. | Posted | Cycle 1 Day 7 (21-day cycle) |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Maximum Concentration (Cmax) for Cycle 1 Day 14 | Cmax was not calculated due to sparse sampling. | Zero participants were analyzed. | Posted | Cycle 1 Day 14 (21-day cycle) |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 14 | 52 | 52 | 52 | ||
| EG001 | 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. | 15 | 50 | 48 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 10.0 | Systematic Assessment | Event resulted in death |
|
| Coronary artery disease | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Infusion related reaction | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment | Event resulted in death in both participants |
|
| Jaundice | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment | Event resulted in death |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pelvic venous thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Infusion related reaction | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Infusion site pain | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Injection site irritation | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vitiligo | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and company | 800-545-5979 |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000096662 | Ramucirumab |
| D003606 | Dacarbazine |
| C029899 | imidazole |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| White |
|
| Other |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| 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. |
|
|
| 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. |
|
|
| 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. |
|
|
|
|