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Colorectal Cancer Metastatic

NCT01670721 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2016-11-28

Study results available
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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.

Conditions

  • Colorectal Cancer Metastatic

Interventions

DRUG

AFLIBERCEPT

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

DRUG

Irinotecan

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

DRUG

Fluorouracil

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

DRUG

Leucovorin

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01670721 on ClinicalTrials.gov