Overview

Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen

Status:
Completed

Trial end date:
2012-06-01

Target enrollment:

Participant gender:

Summary

The main objective of the study was to evaluate the effectiveness of aflibercept (versus placebo) in increasing the overall survival in participants with metastatic colorectal cancer treated with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) and that have previously failed an oxaliplatin based treatment for metastatic disease. The secondary objectives were to compare progression-free survival, to evaluate overall response rate, to evaluate the safety profile, to assess immunogenicity of intravenous (IV) aflibercept, and to assess pharmacokinetics of IV aflibercept in both treatment arms.

Phase:

Phase 3

Details

Lead Sponsor:

Sanofi

Collaborators:

NSABP Foundation Inc
Regeneron Pharmaceuticals

Treatments:

Aflibercept
Camptothecin
Fluorouracil
Irinotecan
Leucovorin
Levoleucovorin
Oxaliplatin