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

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Aflibercept; Irinotecan; Leucovorin; Levoleucovorin

Criteria

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.