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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: aflibercept (AVE0005); Drug: S-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT00479076

TED10089

Details and patient eligibility

About

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.

Enrollment: 22 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)