A Phase I Study of Intravenous Aflibercept in Combination With S-1 in Japanese Cancer Patients

A Single Agent-combination Hybrid Phase I, Open-label, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous AVE0005 (VEGF Trap)Administered Every 2 Weeks in Combination With Oral S-1 in Patients With Advanced Solid Malignancies

The primary objective of this study is to determine the recommended phase II dose of AVE0005 in combination with S-1 in Japanese cancer patients.

The secondary objectives of this study are to assess the safety profile of AVE0005, to determine the pharmacokinetics of AVE0005, to make a preliminary assessment of antitumor effects.

Inclusion Criteria:

• Histologically confirmed cancer patients without standard of care
• ECOG performance status 0, 1, or 2
• Adequate organ and bone marrow function

Exclusion Criteria:

• Need for a major surgery or radiation therapy during the study
• History of hypersensitivity to S-1
• Known dihydropyrimidine dehydrogenase deficiency
• Uncontrolled hypertension
• History of brain metastases
• Ascites requiring drainage
• Pregnancy or breastfeeding
• Patients who have previously been treated with AVE0005

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