Spots Global Cancer Trial Database for Dose Escalation, Safety and Pharmacokinetic Study of SAR103168 in Patients Refractory/ Relapsed Acute Leukemias or High-risk Myelodysplastic Syndromes

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Trial Identification

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

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.

Study ID: NCT00981240

Conditions

Acute Myelogenous Leukemia

Interventions

SAR103168

Study Description

Brief 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

Detailed 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.