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
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".
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assessment of overall response rate (ORR)
Up to a maximum of 1.5 years
Clinical Sciences & Operations
Japan: Ministry of Health, Labor and Welfare