Drug Interaction Study of SAR302503 in Patients With Solid Tumor

Summary

Primary Objective: * To assess the effect of 15-day repeated oral doses of 500 mg SAR302503 on the cytochrome P450 activity using a CYP probe cocktail (2C19, 2D6 and 3A4). * To document pharmacokinetics of SAR302503 after repeated 500 mg oral daily doses. Secondary Objectives: * To assess the safety profile of 15-day repeated oral doses of 500 mg SAR302503 in Segment 1 * To characterize the safety and tolerability of 28-day consecutive doses of 500 mg SAR302503 in Segment 2 * To determine antitumor activity in Segment 2

Timeline

Start

2012-06

Primary completion

2013-03

Completion

2013-03

Drugs

Indications