A Phase 2 Randomized, Open-Label, Dose-Ranging Study of the Efficacy and Safety of Orally Administered SAR302503 in Patients With Intermediate-2 or High Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis With Splenomegaly
The duration of the study for an individual patient will include a period to assess
eligibility (screening period 28 days), followed by a treatment period of at least 1 cycle
(28 days) of study treatment, and an end-of-treatment visit at least 30 days following the
last administration of study drug. However, treatment may continue if patients are deriving
benefit and do not have unacceptable toxicity or meet study withdrawal criteria.
The study duration will be approximately 16 months which includes a 3-month enrollment
period followed by a 12-month treatment period following the last patient enrolled followed
by a 30-day follow-up period. The cut-off date for the analysis of the primary endpoint of
response will be in maximum at the end of 3 months after the date of first dose of study
drug of the last treated patient. The final analysis will be performed after the last
enrolled patient completes the Cycle12 assessment.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The percent change in spleen volume based on MRI at the end of Cycle 3 relative to baseline
1 year
No
Clinical Sciences & Operations
Study Director
Sanofi
United States: Food and Drug Administration
ARD11936
NCT01420770
August 2011
January 2014
Name | Location |
---|---|
Investigational Site Number 840001 | Vallejo, California 94589 |
Investigational Site Number 840007 | Cincinnati, Ohio 45267-0542 |
Investigational Site Number 840003 | Ann Arbor, Michigan 48109 |
Investigational Site Number 840006 | Rochester, Minnesota 55905 |