Colorectal Cancer Metastatic Clinical Trial
Official title:
A Multinational, Randomized, Double-Blind Study of Aflibercept Versus Placebo With Irinotecan/ 5-FU Combination (FOLFIRI) in Patients With Metastatic Colorectal Cancer (MCRC) After Failure of an Oxaliplatin Based Regimen
Primary Objective:
To evaluate the improvement in progression-free survival of aflibercept versus placebo in
participants with metastatic colorectal cancer treated with FOLFIRI as second-line treatment
for metastatic disease.
Secondary Objectives:
To compare the overall survival in the 2 treatment arms. To compare the overall response
rate in the 2 treatment arms. To assess the safety profile of the 2 treatment arms. To
assess immunogenicity of IV aflibercept in selected centers.
Screening occurred from signed informed consent to randomization (up to 21 days). A treatment cycle was defined as a 2 week-period. All participants were followed during the study treatment and follow-up period until death or study cut off date, which ever comes first. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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