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

NCT01661270 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2016-10-18

Study results available
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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.

Conditions

  • Colorectal Cancer Metastatic

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-10-31
Completion
2015-07-31

Countries

  • China
  • Hong Kong
  • Japan
  • Singapore
  • Taiwan

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 NCT01661270 on ClinicalTrials.gov