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

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

Timeline

Start

2009-09

Primary completion

2012-01

Completion

2012-02

Publications

• Roboz GJ, Khoury HJ, Jabbour E, Session W, Ritchie EK, Miao H, Faderl S, Zheng W, Feldman EJ, Arellano M, Morrison JG, Ravandi F. Phase I trial of SAR103168, a novel multi-kinase inhibitor, in patients with refractory/relapsed acute leukemia or high-risk myelodysplastic syndrome. Leuk Lymphoma. 2015 Feb;56(2):395-400. doi: 10.3109/10428194.2014.918970.

Drugs

Indications