Study of Intravenous Aflibercept in Combination With FOLFIRI in Japanese Patients With Metastatic Colorectal Cancer

Sanofi

Status and phase: Completed; Phase 1

Conditions: Neoplasm Metastasis; Colorectal Neoplasms

Treatments: Drug: AVE0005 (aflibercept)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00921661

TCD10794

Details and patient eligibility

About

The primary objective is to determine the dose of aflibercept to be further studied in combination with irinotecan/5-fluorouracil/isovorin (FOLFIRI) in Japanese patients with metastatic colorectal cancer.

Secondary objectives of this study are to assess the safety profile of aflibercept, to determine the pharmacokinetics of aflibercept, to make a preliminary assessment of antitumor effects.

Enrollment: 16 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with histologically or cytologically proven malignant tumor of the colon or rectum which is metastatic and inoperable.
• Patients must have received at least one prior line of treatment with any standard of care, who have failed the treatment, or who have not been eligible for standard of care for safety reasons.

Exclusion criteria

• Treatment with chemotherapy, hormone therapy, radiotherapy, surgery, blood products, or any investigational agent within 28 days.
• ECOG Performance Status>1
• Anticipated need for a major surgical procedure or radiation therapy during the study.
• Uncontrolled malignant ascites.
• History of brain metastases, spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease on screening CT or MRI scan.
• Pregnant or breast-feeding women.
• Uncontrolled hypertension
• Patients who have previously been treated with aflibercept
• History of abdominal fistula, GI perforation, or intra-abdominal abscess within the past 28 days.
• History of hypersensitivity to any recombinant proteins, irinotecan, fluoropyrimidine or isovorin.
• Known dihydropyrimidine dehydrogenase deficiency.

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

AVE0005 (aflibercept)

Experimental group

Treatment:

Drug: AVE0005 (aflibercept)