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Clinical Trial Summary

Primary objectives:

- To determine the maximum tolerated dose (MTD) of SAR103168 and to characterize the dose limiting toxicities (DLTs) in the proposed dose regimen

- To evaluate the pharmacokinetic (PK) profile of SAR103168

Secondary objectives:

- To characterize the global safety profile of SAR103168

- To evaluate preliminary anti-leukemia activity

- To investigate the potential induction effect on CYP3A4 and persistence of this effect by using oral midazolam as a probe substrate in patients enrolled into the expanded cohort at the MTD

- To determine the metabolic pathways of SAR103168 and identify the chemical structures of metabolites

- To determine the potential impact of SAR103168 on the QTc interval in patients enrolled at the MTD


Clinical Trial Description

Patients will receive the study drug until unacceptable toxicity, clinically significant disease progression, withdrawal of consent or investigator's decision, and for a maximum of 1 year. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00981240
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 1
Start date September 2009
Completion date February 2012

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