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

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Aflibercept

Criteria

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.