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

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00921661

Collaborator

Regeneron Pharmaceuticals (Industry)

Enrollment

Location

Arm

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasms Neoplasm Metastasis	Drug: AVE0005 (aflibercept)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AVE0005 (aflibercept)	Drug: AVE0005 (aflibercept) IV infusion

Arm

Intervention/Treatment

Experimental: AVE0005 (aflibercept)

Drug: AVE0005 (aflibercept)

IV infusion

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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.