Dose Escalation, Safety and Pharmacokinetic Study of SAR103168 in Patients Refractory/ Relapsed Acute Leukemias or High-risk Myelodysplastic Syndromes



Status:Archived
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:September 2009
End Date:November 2011

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A Dose Escalation Safety and Pharmacokinetic Study of SAR103168 Administered as a Single Agent by Intravenous Infusion, Once Daily for 5 Consecutive Days to Patients With Refractory/ Relapsed Acute Leukemias or High-risk Myelodysplastic Syndromes.


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


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.


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