Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 in Patients With Solid Tumors

Summary

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. Secondary objectives: * 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.

Timeline

Start

2009-09

Primary completion

2011-08

Completion

2011-08

Publications

• Murakami H, Kurata T, Onozawa Y, Watanabe J, Ono A, Takahashi T, Yamamoto N, Fujisaka Y, Kiyota H, Hayashi H, Tanaka K, Nakagawa K, Kuroda S. An open-label, dose-escalation, safety, and pharmacokinetics phase I study of ombrabulin, a vascular disrupting agent, administered as a 30-min intravenous infusion every 3 weeks in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2014 Mar;73(3):623-30. doi: 10.1007/s00280-014-2388-x. Epub 2014 Jan 30.

Drugs

Indications