CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 332 enrolled
Drug / intervention
Aflibercept +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01661270
NCT01661270Phase 3Completed
CompareCT.gov

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

Sanofi·interventional·Posted Aug 9, 2012·Updated Oct 18, 2016

In Brief

A Phase 3 clinical trial evaluating Aflibercept and Placebo for Colorectal Cancer Metastatic. Completed, enrolled 332 participants across 37 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer Metastatic
CountriesChina, Hong Kong, Japan, Singapore, Taiwan
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 9, 2012
Enrollment StartJul 1, 2012
Primary CompletionOct 1, 2014
Study CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.9 years ago

Interventions

Afliberceptdrug

Pharmaceutical form: Concentrate for Solution for infusion; Route of administration: Intravenous

Placebodrug

Pharmaceutical form: Concentrate for Solution for infusion; Route of administration: Intravenous