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- 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
- To characterize the global safety profile of SAR103168
- To evaluate preliminary anti-leukemia activity
- To evaluate the inhibition of signal transducer and activators of transcription (STAT5) phosphorylation as a surrogate pharmacodynamic end point of 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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Acute Myelogenous Leukemia
Sanofi-Aventis Investigational Site Number 840002
Published on BioPortfolio: 2014-07-24T14:11:28-0400
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