Acute Myelogenous Leukemia Clinical Trial
Official title:
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. ;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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