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

Phase 1

Completed

• Conditions: Colorectal Neoplasms; Neoplasm Metastasis
• Interventions: Drug: AVE0005 (aflibercept)

• Registration Number: NCT00921661
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-15
• Study First Submitted QC: 2009-06-15
• Study First Posted: 2009-06-16
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-08
• Last Update Posted: 2012-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AVE0005 (aflibercept)	AVE0005 (aflibercept)	-

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity (DLT) combination with FOLFIRI	During the first 2 cycles (4 weeks) of study treatment

Secondary Outcome Measures

Name	Time	Method
physical examination, laboratory safety tests, adverse events	up to 60 days after last treatment
Pharmacokinetics	up to 90 days after last treatment
Tumor burden, endogenous free VEGF	every 3 cycles
Immunogenicity	up to 90 days after last treatment

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇯🇵 Tokyo, Japan