A Study of Aflibercept in Combination With FOLFIRI in Patients With Second-Line Metastatic Colorectal Cancer in Japan

Colorectal Cancer Metastatic Clinical Trial

Official title: A Single-Arm Phase II Study in Japan to Assess the Efficacy and Safety of Aflibercept Administered Every Two Weeks in Combination With FOLFIRI in Patients With Metastatic Colorectal Cancer Who Progressed During or Following an Oxaliplatin-Based Regimen

Status Completed

Clinical Trial Summary

Primary Objective:

To assess efficacy aflibercept + FOLFIRI by objective response rate (ORR)

Secondary Objective:

To assess the following:

• safety profile

• progression free survival (PFS)

• overall survival (OS)

• pharmacokinetics (PK)

• immunogenicity

Clinical Trial Description

Screening is up to 24 days. Treatment period will continue until disease progression, unacceptable toxicity, or patient's refusal. Follow up period will continue until death, patient's refusal, or end of study, whichever comes first.

This trial is being conducted in Japan, where the INN designation for the study molecule is "aflibercept" and this term is therefore used throughout the synopsis. In the US, the US proper name is "ziv-aflibercept". ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

• NCT number: NCT01882868
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 2
• Start date: July 2013
• Completion date: August 2015