NCT01661270

A Study of Aflibercept Versus Placebo With FOLFIRI in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin Chemotherapy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 332 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To evaluate the improvement in progression-free survival (PFS) 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 (OS) in the 2 treatment arms. To compare the overall response rate (ORR) in the 2 treatment arms. To assess the safety profile of the 2 treatment arms. To assess immunogenicity of intravenous (IV) aflibercept in selected centers.

Detailed description

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.

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Aflibercept	Pharmaceutical form: Concentrate for Solution for infusion; Route of administration: Intravenous
DRUG	Placebo	Pharmaceutical form: Concentrate for Solution for infusion; Route of administration: Intravenous

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-10-01
• Completion: 2015-07-01
• First posted: 2012-08-09
• Last updated: 2016-10-18
• Results posted: 2015-11-26

Locations

37 sites across 5 countries: China, Hong Kong, Japan, Singapore, Taiwan