Neoplasm Malignant Clinical Trial
Official title:
Effect of 14-day Repeated Oral Doses of SAR302503 on Ventricular Repolarization, Compared to 1-day Placebo in Adult Patients With Refractory Solid Tumors
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
Total 7-10 weeks if not progressing to Segment 2. Segment 2 will be additional in 28-day cycles. ;
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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