The purpose of this study is to test how long participants with colorectal cancer live without progressive disease when being treated with IMC-1121B (ramucirumab) and the modified FOLFOX-6 chemotherapy.
The purpose of this study is to evaluate the progression-free survival (PFS) in participants with metastatic colorectal cancer when treated with the monoclonal antibody IMC-1121B (ramucirumab) in combination with the modified FOLFOX-6 \[folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6\] chemotherapy regimen as first-line therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
8 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) infusions every 2 weeks
85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1
400 mg/m² intravenous infusion over 2 hours on Day 1
ImClone Investigational Site
Ottawa, Ontario, Canada
ImClone Investigational Site
Toronto, Ontario, Canada
ImClone Investigational Site
Montreal, Quebec, Canada
ImClone Investigational Site
Barcelona, Spain
Progression-Free Survival (PFS)
PFS was defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion. For participants who had no PD or death or had started new therapeutic anticancer treatment, PFS was censored at their last radiographic tumor assessment.
Time frame: First dose to measured progressive disease or death due to any cause up to 28.1 months
Percentage of Participants With Complete Response or Partial Response [Objective Response Rate (ORR)]
ORR is the percentage of participants with a confirmed complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion. ORR is calculated as a total number of participants with CR or PR from the start of study treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.
Time frame: First dose to date of objective progressive disease up to 23.8 months
Overall Survival (OS)
OS was defined as the time from first dose to the date of death due to any cause. For participants who were alive or were lost to follow-up, OS was censored on the last date the participant was known to be alive.
Time frame: First dose to death due to any cause up to 28.1 months
Duration of Response
The duration of response was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion.
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400 mg/m² intravenous bolus injection over 2-4 minutes, immediately following folinic acid infusion
2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU on Days 1 and 2
ImClone Investigational Site
Santander, Spain
ImClone Investigational Site
Seville, Spain
ImClone Investigational Site
Valencia, Spain
Time frame: Time of response to time of measured progressive disease up to 22.2 months
Number of Participants With IMC-1121B (Ramucirumab)-Related Adverse Events (AEs)
Data presented are the number of participants who experienced AEs of any grade and AEs of Grade ≥3 based on National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v 3.0), that were considered to be related to IMC-1121B (ramucirumab) by the investigators. A summary of serious AEs (SAEs) and all other non-serious AEs regardless of causality, is located in the Reported Adverse Events module.
Time frame: First dose to 25.2 months
Number of Participants With IMC-1121B (Ramucirumab)-Related Severe Adverse Events (SAEs)
Data presented are the number of participants who experienced SAEs, adverse events (AEs) resulting in death and AEs leading to discontinuation of treatment, that were considered to be related to IMC-1121B (ramucirumab) by the investigators. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Time frame: First dose to 25.2 months
Maximum Concentration (Cmax) at Day 1 of Cycle 1
Due to sparse pharmacokinetic schedule, Cmax was not calculated.
Time frame: Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)
Area Under the Concentration (AUC) at Day 1 of Cycle 1
Due to sparse pharmacokinetic schedule, AUC was not calculated.
Time frame: Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)
Half-Life (t1/2) at Day 1 of Cycle 1
Due to sparse pharmacokinetic schedule, t1/2 was not calculated.
Time frame: Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)
Clearance (CL) at Day 1 of Cycle 1
Due to sparse pharmacokinetic schedule, CL was not calculated.
Time frame: Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)
Steady State Volume of Distribution (Vss) at Day 1 of Cycle 1
Due to sparse pharmacokinetic schedule, Vss was not calculated.
Time frame: Baseline, 1, 168, and 336 hours post infusion Day 1 (Cycle 1)
Maximum Concentration (Cmax) at Day 1 of Cycles 5, 9, 13, 17, and 21
Due to sparse pharmacokinetic schedule, Cmax was not calculated.
Time frame: Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)
Area Under the Concentration (AUC) at Day 1 of Cycles 5, 9, 13, 17, and 21
Due to sparse pharmacokinetic schedule, AUC was not calculated.
Time frame: Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)
Half-Life (t1/2) at Day 1 of Cycles 5, 9, 13, 17, and 21
Due to sparse pharmacokinetic schedule, t1/2 was not calculated.
Time frame: Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)
Clearance (CL) at Day 1 of Cycles 5, 9, 13, 17, and 21
Due to sparse pharmacokinetic schedule, CL was not calculated.
Time frame: Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)
Steady State Volume of Distribution (Vss) at Day 1 of Cycles 5, 9, 13, 17, and 21
Due to sparse pharmacokinetic schedule, Vss was not calculated.
Time frame: Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)
Serum Anti-IMC-1121B (Immunogenicity) at Day 1
Data presented are the number of participants with treatment emergent anti-IMC-112B antibodies.
Time frame: Day 1 (Cycles 1, 5, 9, and 30-day follow-up)