A Phase II, Multicenter, Open Label, Single Arm Study of SAR302503 in Subjects Previously Treated With Ruxolitinib and With a Current Diagnosis of Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis
The expected duration of the 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
EOT visit for subjects who will not continue the treatment after completing the 6 cycles of
SAR302503, or discontinue the treatment early for any reasons as well as a follow-up visit
which should occur 30 days after the last administration of SAR302503. Patients who continue
to benefit clinically will be allowed to remain on study medication beyond the 6-month
treatment period until the occurrence of disease progression or unacceptable toxicity.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate (RR), defined as the proportion of subjects who have a ≥35% reduction from baseline in volume of spleen at the end of Cycle 6 as measured by Magnetic Resonance Imaging (MRI) (or CT scan in subjects with contraindications for MRI)
6 months
Yes
Clinical Sciences & Operations
Study Director
Sanofi
United States: Food and Drug Administration
ARD12181
NCT01523171
April 2012
September 2019
Name | Location |
---|---|
Investigational Site Number 840011 | Kettering, Ohio 45429 |
Investigational Site Number 840004 | Santa Monica, California 90403 |
Investigational Site Number 840003 | San Diego, California 92123 |
Investigational Site Number 840005 | Savannah, Georgia 31403 |
Investigational Site Number 840009 | Valhalla, New York 10595 |
Investigational Site Number 840010 | Ann Arbor, Michigan 48109 |
Investigational Site Number 840002 | Houston, Texas 77030 |
Investigational Site Number 840007 | Casa Grande, Arizona 85222 |
Investigational Site Number 840022 | Sylvania, Ohio 43560 |
Investigational Site Number 840014 | Chicago, Illinois 60637 |
Investigational Site Number 840001 | Kansas City, Kansas 66160-7321 |
Investigational Site Number 840013 | Baltimore, Maryland 21229 |
Investigational Site Number 840017 | Baltimore, Maryland 21201 |
Investigational Site Number 840019 | Middletown, Ohio 45042 |
Investigational Site Number 840023 | San Antonio, Texas 78229 |
Investigational Site Number 840015 | Salt Lake City, Utah 84112-5550 |