Phase II, Open Label, Single Arm Study of SAR302503 In Myelofibrosis Patients Previously Treated With Ruxolitinib
Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
- To evaluate the efficacy of once daily dose of SAR302503 in subjects previously treated
with ruxolitinib and with a current diagnosis of intermediate-1 with symptoms, Intermediate-2
or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (Post-PV MF),
or post-essential thrombocythemia myelofibrosis (Post-ET MF) based on the reduction of spleen
volume at the end of 6 treatment cycles;
Secondary Objectives:
- To evaluate the effect of SAR302503 on Myelofibrosis (MF) associated symptoms as
measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary
- To evaluate the durability of splenic response
- To evaluate the splenic response to SAR302503 by palpation at the end of Cycle 6
- To evaluate the splenic response to SAR302503 at the end of Cycle 3
- To evaluate the effect of SAR302503 on the Janus kinase 2 (JAK2) V617F allele burden
- To evaluate the safety and tolerability of SAR302503 in this population
- To evaluate plasma concentrations of SAR302503 for population PK analysis, if warranted