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Clinical Trial Summary

Primary Objectives:

- To determine safety and the maximum tolerated dose (MTD) of SAR405838 through the characterization of dose-limiting toxicities (DLTs).

- To assess biological activities in patients with dedifferentiated liposarcoma during MTD cohort expansion.

Secondary Objectives:

- Pharmacokinetic (PK) profile of SAR405838.

- Biomarkers in association with SAR405838.

- Anti-tumor activity in response to SAR405838.

- Food effect on SAR405838 PK.

- Compliance with SAR405838 treatment.

- Cytochrome P450 3A4/5 (CYP3A4/5) activity.


Clinical Trial Description

Total duration of study participation for each patient will be one month screening followed by treatment until precluded by toxicity, noncompliance, progression, or death. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01636479
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 1
Start date July 13, 2012
Completion date March 5, 2018

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