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Dose Escalation, Safety and Pharmacokinetic Study of SAR103168 in Patients With Myelogenous Leukemia

2014-07-24 14:11:28 | BioPortfolio

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 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

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

Conditions

Acute Myelogenous Leukemia

Intervention

SAR103168

Location

Sanofi-Aventis Investigational Site Number 840002
New York
New York
United States
10021

Status

Recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:11:28-0400

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