NCT00981240

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

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myelogenous Leukemia

Interventions

Type	Name	Description
DRUG	SAR103168	Pharmaceutical form: Concentrate for solution for infusion Route of administration: Intravenous infusion

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-01-01
• Completion: 2012-02-01
• First posted: 2009-09-22
• Last updated: 2012-03-27

Locations

3 sites across 1 country: United States