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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
intravenous infusion
oral administration
Sanofi-Aventis Administrative Office
Tokyo, Japan
Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities
Time frame: during the first cycle of study treatment
safety: physical examination, laboratory safety tests, adverse events
Time frame: treatment period
pharmacokinetic values
Time frame: treatment period
objective response rate
Time frame: treatment period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.