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Primary objective: To determine the maximum tolerated dose based on the incidence of dose limiting toxicity and the maximum administered dose of AVE8062 administered every 3 weeks in patients with advanced solid tumors.
- To assess the overall safety profile of the drug.
- To characterize the pharmacokinetic profile of AVE8062 and its active metabolite RPR 258063.
- To evaluate anti-tumor activity of the drug.
The duration of the study for each patient will include an up to 4-week screening phase, 21-day study treatment cycles, an end of treatment visit and a follow-up period.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Sanofi-Aventis Administrative Office
Published on BioPortfolio: 2014-08-27T03:19:38-0400
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