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Brief Title: Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis
Official Title: 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
Study ID: NCT01437787
Brief Summary: Primary Objective: * To evaluate the efficacy of daily oral doses of 400 mg or 500 mg of SAR302503 (Investigational Medicinal Product, IMP) compared to placebo in the reduction of spleen volume as determined by magnetic resonance imaging (MRI) (or computed tomography scan in patients with contraindications for MRI). Secondary Objectives: * To evaluate the effect on Myelofibrosis (MF)-associated symptoms (key MF symptoms) as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary. * To evaluate the Overall Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo. * To evaluate the Progression Free Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo. * To evaluate the durability of splenic response. * To evaluate the safety of IMP.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Investigational Site Number 840014, Scottsdale, Arizona, United States
Investigational Site Number 840001, La Jolla, California, United States
Investigational Site Number 840012, La Jolla, California, United States
Investigational Site Number 840006, Los Angeles, California, United States
Investigational Site Number 840013, Baton Rouge, Louisiana, United States
Investigational Site Number 840008, Rochester, Minnesota, United States
Investigational Site Number 840009, Newark, New Jersey, United States
Investigational Site Number 840002, Canton, Ohio, United States
Investigational Site Number 840004, Houston, Texas, United States
Investigational Site Number 036001, Box Hill, , Australia
Investigational Site Number 036005, Herston, , Australia
Investigational Site Number 036003, Randwick, , Australia
Investigational Site Number 036004, Tweed Heads, , Australia
Investigational Site Number 036002, Wodonga, , Australia
Investigational Site Number 040001, Wien, , Austria
Investigational Site Number 056003, Antwerpen, , Belgium
Investigational Site Number 056001, Leuven, , Belgium
Investigational Site Number 076002, Jau, , Brazil
Investigational Site Number 076004, Porto Alegre, , Brazil
Investigational Site Number 076001, Rio De Janeiro, , Brazil
Investigational Site Number 124001, Montreal, , Canada
Investigational Site Number 124003, Montreal, , Canada
Investigational Site Number 124002, Saint John, , Canada
Investigational Site Number 250006, Marseille, , France
Investigational Site Number 250005, Nantes Cedex 01, , France
Investigational Site Number 250004, Nimes, , France
Investigational Site Number 250002, Pierre Benite Cedex, , France
Investigational Site Number 250007, Poitiers, , France
Investigational Site Number 250003, Toulouse, , France
Investigational Site Number 250001, Villejuif Cedex, , France
Investigational Site Number 276006, Aachen, , Germany
Investigational Site Number 276007, Bonn, , Germany
Investigational Site Number 276008, Dresden, , Germany
Investigational Site Number 276001, Mannheim, , Germany
Investigational Site Number 348002, Budapest, , Hungary
Investigational Site Number 348001, Debrecen, , Hungary
Investigational Site Number 348007, Györ, , Hungary
Investigational Site Number 348006, Kecskemét, , Hungary
Investigational Site Number 348003, Miskolc, , Hungary
Investigational Site Number 372002, Dublin, , Ireland
Investigational Site Number 372001, Galway, , Ireland
Investigational Site Number 376003, Haifa, , Israel
Investigational Site Number 376002, Tel Hashomer, , Israel
Investigational Site Number 380002, Bergamo, , Italy
Investigational Site Number 380007, Bologna, , Italy
Investigational Site Number 380004, Firenze, , Italy
Investigational Site Number 380001, Pavia, , Italy
Investigational Site Number 380006, Pavia, , Italy
Investigational Site Number 380003, Varese, , Italy
Investigational Site Number 410002, Bundang-Gu, , Korea, Republic of
Investigational Site Number 410004, Seoul, , Korea, Republic of
Investigational Site Number 410003, Seoul, , Korea, Republic of
Investigational Site Number 410001, Seoul, , Korea, Republic of
Investigational Site Number 410005, Seoul, , Korea, Republic of
Investigational Site Number 410006, Seoul, , Korea, Republic of
Investigational Site Number 410007, Seoul, , Korea, Republic of
Investigational Site Number 440001, Kaunas, , Lithuania
Investigational Site Number 440002, Klaipeda, , Lithuania
Investigational Site Number 484001, Queretaro, , Mexico
Investigational Site Number 616005, Brzozow, , Poland
Investigational Site Number 616002, Gdansk, , Poland
Investigational Site Number 616006, Lodz, , Poland
Investigational Site Number 616010, Warszawa, , Poland
Investigational Site Number 616003, Wroclaw, , Poland
Investigational Site Number 620005, Coimbra, , Portugal
Investigational Site Number 620004, Lisboa, , Portugal
Investigational Site Number 620001, Lisboa, , Portugal
Investigational Site Number 620003, Porto, , Portugal
Investigational Site Number 642003, Brasov, , Romania
Investigational Site Number 642004, Bucharest, , Romania
Investigational Site Number 642002, Bucuresti, , Romania
Investigational Site Number 642006, Bucuresti, , Romania
Investigational Site Number 642001, Timisoara, , Romania
Investigational Site Number 643009, Moscow, , Russian Federation
Investigational Site Number 643001, Moscow, , Russian Federation
Investigational Site Number 643010, Nizhny Novgorod, , Russian Federation
Investigational Site Number 643008, Petrozavodsk, , Russian Federation
Investigational Site Number 643004, St-Petersburg, , Russian Federation
Investigational Site Number 643005, St.-Petersburg, , Russian Federation
Investigational Site Number 643007, Volgograd, , Russian Federation
Investigational Site Number 702002, Singapore, , Singapore
Investigational Site Number 702001, Singapore, , Singapore
Investigational Site Number 710003, Johannesburg, , South Africa
Investigational Site Number 710002, Parktown, , South Africa
Investigational Site Number 724001, Barcelona, , Spain
Investigational Site Number 724002, Madrid, , Spain
Investigational Site Number 752001, Stockholm, , Sweden
Investigational Site Number 752002, Uddevalla, , Sweden
Investigational Site Number 158002, Changhua, , Taiwan
Investigational Site Number 158003, Kaohsiung, , Taiwan
Investigational Site Number 158001, Taipei, , Taiwan
Investigational Site Number 826006, Belfast, , United Kingdom
Investigational Site Number 826003, Birmingham, , United Kingdom
Investigational Site Number 826002, Glasgow, , United Kingdom
Investigational Site Number 826004, Leeds, , United Kingdom
Investigational Site Number 826001, London, , United Kingdom
Investigational Site Number 826005, London, , United Kingdom
Investigational Site Number 826007, Manchester, , United Kingdom
Investigational Site Number 826008, Newcastle Upon Tyne, , United Kingdom
Investigational Site Number 826009, Oxford, , United Kingdom
Investigational Site Number 826010, Southampton, , United Kingdom
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR