CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 175 enrolled
Drug / intervention
AFLIBERCEPT +3 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/NCT01670721
NCT01670721Phase 3Completed
CompareCT.gov

A Multicenter, Single Arm, Open Label Clinical Trial Evaluating Safety and Health Related Quality of Life of Aflibercept in Combination With Irinotecan/5-FU Chemotherapy (FOLFIRI) in Patients With Metastatic Colorectal Cancer (mCRC) Previously Treated With an Oxaliplatin-Containing Regimen

Sanofi·interventional·Posted Aug 22, 2012·Updated Nov 28, 2016

In Brief

A Phase 3 clinical trial evaluating AFLIBERCEPT, Irinotecan, and 2 other interventions for Colorectal Cancer Metastatic. Completed, enrolled 175 participants across 1 site.

Detailed Summary

Primary Objective: To evaluate the safety of aflibercept in participants with mCRC treated with irinotecan/5-Fluorouracil (5-FU) combination (FOLFIRI) after failure of an oxaliplatin-based regimen (participants similar to those evaluated in the VELOUR trial \[EFC10262, NCT00561470\]) according to side effects prevention and management guidelines. Secondary Objective: To document the Health-Related Quality of Life (HRQL) of aflibercept in this participant population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer Metastatic
CountriesFrance
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 22, 2012
Enrollment StartAug 1, 2012
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.9 years ago

Interventions

AFLIBERCEPTdrug

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

Irinotecandrug

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

Fluorouracildrug

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

Leucovorindrug

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