A Phase I Study of Intravenous Aflibercept in Combination With S-1 in Japanese Cancer Patients
NCT00479076 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2011-01-26
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.
Conditions
- Neoplasms
Interventions
- DRUG
-
aflibercept (AVE0005)
intravenous infusion
- DRUG
-
S-1
oral administration
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Clinical Sciences & Operations · Sanofi
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-03-31
- Primary Completion
- 2011-01-31
- Completion
- 2011-01-31
Countries
- Japan
Study Locations
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