Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT01836705
Brief 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
Detailed Description:
Total 7-10 weeks if not progressing to Segment 2. Segment 2 will be additional in 28-day cycles.
Study:
NCT01836705
Study Brief:
Protocol Section:
NCT01836705