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

Colorectal Neoplasms Clinical Trial

Official title:

A Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Aflibercept in Combination With Intravenous Irinotecan/5-fluorouracil/Isovorin (FOLFIRI) Administered Every 2 Weeks in Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921661
• Other study ID #: TCD10794
• Status: Completed
• Phase: Phase 1
• First received: June 15, 2009
• Last updated: November 8, 2012
• Start date: June 2009
• Est. completion date: June 2012

Study information

• Verified date: November 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Neoplasm Metastasis
• Neoplasms

Intervention

Drug:
• AVE0005 (aflibercept)
IV infusion

Locations

Country	Name	City	State
Japan	Sanofi-Aventis Administrative Office	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity (DLT) combination with FOLFIRI		During the first 2 cycles (4 weeks) of study treatment	Yes
Secondary	physical examination, laboratory safety tests, adverse events		up to 60 days after last treatment	Yes
Secondary	Pharmacokinetics		up to 90 days after last treatment	No
Secondary	Tumor burden, endogenous free VEGF		every 3 cycles	No
Secondary	Immunogenicity		up to 90 days after last treatment	Yes