A Phase I Study of Aflibercept Plus FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) in Chinese Patients With Advanced Solid Malignancies

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

To assess the safety and pharmacokinetics preliminarily of the dose of intravenous (IV) aflibercept used in western studies in combination with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) given intravenously every 2 weeks in Chinese patients with solid tumors.

Secondary Objectives:

• To make a preliminary assessment of antitumor effects of the combination of FOLFIRI plus aflibercept in patients with measurable disease (RECIST 1.1).

• To evaluate the immunogenicity of IV aflibercept.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion criteria:

• Histologically or cytologically confirmed solid malignancy that is metastatic or unresectable for which FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) treatment is appropriate

Exclusion criteria:

• Treatment with chemotherapy, hormonal therapy, radiotherapy, surgery, or an investigational agent within 28 days

• Eastern Cooperative Oncology Group (ECOG) >1

• Need for a major surgical procedure or radiation therapy during the study

• Diagnosis of squamous-cell lung cancer

• Cumulative radiation therapy to > 25% of the total bone marrow

• History of brain metastases

• Inadequate organ and bone marrow function

• Uncontrolled hypertension

• Evidence of clinically significant bleeding diathesis or underlying coagulopathy

• Prior FOLFIRI treatment but have not been appropriate for safety reasons

• Patients with known Gilbert's syndrome

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