Spots Global Cancer Trial Database for Phase II, Open Label, Single Arm Study of SAR302503 In Myelofibrosis Patients Previously Treated With Ruxolitinib
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Phase II, Open Label, Single Arm Study of SAR302503 In Myelofibrosis Patients Previously Treated With Ruxolitinib
Official Title: 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
Study ID: NCT01523171
Conditions
Interventions
Study Description
Brief 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
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Investigational Site Number 840007, Phoenix, Arizona, United States
Investigational Site Number 840003, San Francisco, California, United States
Investigational Site Number 840004, San Francisco, California, United States
Investigational Site Number 840005, Atlanta, Georgia, United States
Investigational Site Number 840014, Chicago, Illinois, United States
Investigational Site Number 840001, Kansas City, Kansas, United States
Investigational Site Number 840017, Baltimore, Maryland, United States
Investigational Site Number 840013, Baltimore, Maryland, United States
Investigational Site Number 840010, Ann Arbor, Michigan, United States
Investigational Site Number 840009, New York, New York, United States
Investigational Site Number 840018, New York, New York, United States
Investigational Site Number 840022, Cleveland, Ohio, United States
Investigational Site Number 840019, Middletown, Ohio, United States
Investigational Site Number 840024, Charleston, South Carolina, United States
Investigational Site Number 840002, Houston, Texas, United States
Investigational Site Number 840015, Salt Lake City, Utah, United States
Investigational Site Number 040002, Salzburg, , Austria
Investigational Site Number 040001, Wien, , Austria
Investigational Site Number 056002, Antwerpen, , Belgium
Investigational Site Number 056003, Leuven, , Belgium
Investigational Site Number 124001, Toronto, , Canada
Investigational Site Number 250001, Marseille, , France
Investigational Site Number 250003, Nimes Cedex 9, , France
Investigational Site Number 250002, Paris Cedex 10, , France
Investigational Site Number 250006, Paris Cedex 12, , France
Investigational Site Number 250004, Toulouse, , France
Investigational Site Number 276003, Frankfurt Am Main, , Germany
Investigational Site Number 276007, Leipzig, , Germany
Investigational Site Number 276006, Magdeburg, , Germany
Investigational Site Number 276001, Mannheim, , Germany
Investigational Site Number 276005, Ulm, , Germany
Investigational Site Number 380004, Firenze, , Italy
Investigational Site Number 380001, Milano, , Italy
Investigational Site Number 380002, Roma, , Italy
Investigational Site Number 380003, Varese, , Italy
Investigational Site Number 528002, Amsterdam, , Netherlands
Investigational Site Number 528003, Maastricht, , Netherlands
Investigational Site Number 528001, Nijmegen, , Netherlands
Investigational Site Number 724001, Barcelona, , Spain
Investigational Site Number 724003, Majadahonda, , Spain
Investigational Site Number 724002, Salamanca, , Spain
Investigational Site Number 826001, London, , United Kingdom
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
