NCT01882868

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To assess efficacy aflibercept + 5-fluorouracil (5-FU)/levofolinate/irinotecan (FOLFIRI) by objective response rate (ORR). Secondary Objective: To assess the following: * safety profile; * progression free survival (PFS); * overall survival (OS); * pharmacokinetics (PK); * immunogenicity.

Detailed description

Screening was up to 24 days. Treatment period was continued until DP, unacceptable toxicity, or participant's refusal. Follow up period was continued until death, participant's refusal, or end of study, whichever came first. This trial was conducted in Japan, where the International Nonproprietary Name (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".

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Aflibercept	Pharmaceutical form: Concentrated solution (100 mg/4 mL \[25 mg/mL\], 200 mg/8 mL \[25 mg/mL\]) for infusion; Route of administration: Intravenous
DRUG	Levofolinate	Pharmaceutical form: Solution for infusion (marketed formulation); Route of administration: Intravenous
DRUG	Irinotecan	Pharmaceutical form: Solution for infusion (marketed formulation); Route of administration: Intravenous
DRUG	5-FU	Pharmaceutical form: Solution for infusion (marketed formulation); Route of administration: Intravenous

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2013-06-20
• Last updated: 2017-03-14
• Results posted: 2017-03-14

Locations

19 sites across 1 country: Japan