Effect of SAR302503 on ECG Activity in Patients With Solid Tumors
Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
- To assess the effect of SAR302503 (500 mg) administered as 14-day repeated doses on the
QTcF interval compared to 1-day placebo in patients with advanced solid tumors.
Secondary Objectives:
- To assess the effect of SAR302503 administered as 14-day repeated doses on heart rate
(HR), QT, QTcB, and QTcN, PR and QRS compared to placebo.
- To assess the clinical and laboratory safety of SAR302503
- To document the plasma concentrations of SAR302503 at the time of ECG investigation.
- To explore the Pharmacokinetic/Pharmacodynamic relationship between SAR302503
concentration and QTcF
- To explore antitumor activity