A Phase I Study of Intravenous Aflibercept in Combination With S-1 in Japanese Cancer Patients
Phase 1
Completed
- Conditions
- Neoplasms
- Registration Number
- NCT00479076
- Lead Sponsor
- Sanofi
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities during the first cycle of study treatment
- Secondary Outcome Measures
Name Time Method safety: physical examination, laboratory safety tests, adverse events treatment period pharmacokinetic values treatment period objective response rate treatment period
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇯🇵Tokyo, Japan