Phase 2 Study in Japanese Patients With Intermediate-2 or High Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis With Splenomegaly

Summary

Primary Objective: \- To evaluate the efficacy of daily oral doses of 300 mg, 400 mg, and 500 mg SAR302503 and combined for the response rate defined with the ≥35% reduction of spleen volume as determined by magnetic resonance imaging (MRI or computed tomography scan \[CT\] in patients with contraindications for MRI). Secondary Objectives: * To evaluate the safety of SAR302503 for both pooled (300, 400, and 500mg) and individual doses population. * To evaluate the pharmacokinetics (PK) of SAR302503 after single and repeat-dose. * To evaluate the effect on Myelofibrosis (MF)-associated symptoms (Key MF symptoms) as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF). * To evaluate the durability of splenic response. * To evaluate the effect of SAR302503 on bone marrow with regard to changes on reticulin fibrosis.

Timeline

Start

2012-11

Primary completion

2014-03

Completion

2014-03

Drugs

Indications