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

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.

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".

Inclusion criteria:

• Histologically or cytologically proven adenocarcinoma of the colon or rectum.
• Metastatic disease that was not amenable to potentially curative treatment.
• Participants with measurable disease.
• One prior chemotherapeutic regimen (containing oxaliplatin) for metastatic disease.
• Participants who relapsed within 6 months of completion of oxaliplatin-based adjuvant chemotherapy were also eligible.

Exclusion criteria:

• Prior therapy with irinotecan.
• Less than 28 days elapsed from prior radiotherapy, prior surgery, or prior chemotherapy to the time of registration.
• Unresolved toxicity (grade >1) from prior anticancer therapy.
• Eastern Cooperative Oncology Group (ECOG) performance status >1.
• Brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis.
• Other prior malignancy.
• Pregnant or breast-feeding women.
• Uncontrolled hypertension.
• Inadequate bone marrow function, liver function, or renal function.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.