A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study of SAR302503 in Patients With Intermediate-2 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis With Splenomegaly
The expected duration of a patient's treatment in this study is approximately 8 months,
based on a maximum 28-day screening period, followed by a ≥6-month (6-cycle) treatment
period, and an End Of Treatment (EOT) visit, which should be performed at least 30 days
following the last administration of IMP or placebo.
Patients who continue to benefit clinically will be allowed to remain on IMP or placebo
beyond the 6-month treatment period until the occurrence of disease progression or
unacceptable toxicity.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Response Rate (RR), defined as the proportion of patients who have a ≥35% reduction in volume of spleen size at the end of Cycle 6, and confirmed 4 weeks thereafter
6 months
No
Clinical Sciences & Operations
Study Director
Sanofi
United States: Food and Drug Administration
EFC12153
NCT01437787
December 2011
March 2016
Name | Location |
---|---|
Investigational Site Number 840006 | San Diego, California 92120 |
Investigational Site Number 840001 | Vallejo, California 94589 |
Investigational Site Number 840002 | Cincinnati, Ohio 45267-0542 |
Investigational Site Number 840012 | San Francisco, California 94143 |
Investigational Site Number 840014 | Scottsdale, Arizona 85259-5499 |
Investigational Site Number 840013 | Baton Rouge, Louisiana 70808 |
Investigational Site Number 840008 | Rochester, Minnesota 55905 |
Investigational Site Number 840009 | Newark, New Jersey 07112 |
Investigational Site Number 840004 | Houston, Texas 77030 |