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NCT01437787

PHASE3

Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

289

Start Date

2011-12-31

Completion Date

2014-06-30

Last Updated

2026-08-11

Healthy Volunteers

Conditions

Hematopoietic Neoplasm

Interventions

DRUG

SAR302503

Pharmaceutical form:capsule Route of administration: oral

DRUG

Placebo

Pharmaceutical form:capsule Route of administration: oral

Inclusion criteria: * Diagnosis of Primary Myelofibrosis (MF) or Post-Polycythemia Vera MF or Post-Essential Thrombocythemia MF, according to the 2008 World Health Organization and International Working Group of Myelofibrosis Research and Treatment (IWG-MRT) criteria. * MF classified as high-risk or intermediate-risk level 2, as defined by modified IWG-MRT criteria (IPSS) (according to Cervantes F. et. al.; at screening). * Enlarged spleen, palpable at least 5 cm below costal margin. * At least 18 years of age. * Eastern Cooperative Oncology Group performance status of 0, 1, or 2 at study entry. * The following laboratory values within 14 days prior to the initiation of IMP or placebo: * Absolute Neutrophil Count (ANC) ≥1.0 x 10exp9/L * Platelet count ≥50 x 10exp9/L * Serum creatinine ≤1.5 x Upper Limit of Normal (ULN) * Serum amylase and lipase ≤1.5 x ULN Exclusion criteria: * Splenectomy. * Any chemotherapy (eg, hydroxyurea), immunomodulatory drug therapy (eg, thalidomide, interferon-alpha), Anagrelide, immunosuppressive therapy, corticosteroids \>10 mg/day prednisone or equivalent, or growth factor treatment (eg, erythropoietin), or hormones (eg, androgens, danazol) within 14 days prior to initiation of IMP or placebo; darbepoetin use within 28 days prior to initiation of IMP or placebo. Patients who have had exposure to hydroxyurea (eg, hydrea) in the past may be enrolled into the study as long as it has not been administered within 14 days prior to initiation of IMP or placebo. * Major surgery within 28 days or radiation within 6 months prior to initiation of IMP or placebo. * Prior treatment with a Janus Kinase 2 (JAK2) inhibitor. * Known active (acute or chronic) Hepatitis A, B, or C; and hepatitis B and C carriers * AST or ALT ≥2.5 x ULN * Total Bilirubin: * Exclude if ≥3.0 x ULN * Patients with total bilirubin between 1.5-3.0 x ULN must be excluded if the direct bilirubin fraction is ≥25% of the total * Prior history of chronic liver disease (eg, chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemachromatosis, non-alcoholic steatohepatitis \[NASH\]) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (101)

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

Vienna, Austria

Investigational Site Number 056003

Antwerp, Belgium

Investigational Site Number 056001

Leuven, Belgium

Investigational Site Number 076002

Jaú, 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, France

Investigational Site Number 250004

Nîmes, France

Investigational Site Number 250002

Pierre-Bénite, France

Investigational Site Number 250007

Poitiers, France

Investigational Site Number 250003

Toulouse, France

Investigational Site Number 250001

Villejuif, 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

Győr, 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 Litwinsky, Israel

Investigational Site Number 380002

Bergamo, Italy

Investigational Site Number 380007

Bologna, Italy

Investigational Site Number 380004

Florence, Italy

Investigational Site Number 380001

Pavia, Italy

Investigational Site Number 380006

Pavia, Italy

Investigational Site Number 380003

Varese, Italy

Investigational Site Number 440001

Kaunas, Lithuania

Investigational Site Number 440002

Klaipėda, Lithuania

Investigational Site Number 484001

Querétaro, Mexico

Investigational Site Number 616005

Brzozów, Poland

Investigational Site Number 616002

Gdansk, Poland

Investigational Site Number 616006

Lodz, Poland

Investigational Site Number 616010

Warsaw, Poland

Investigational Site Number 616003

Wroclaw, Poland

Investigational Site Number 620005

Coimbra, Portugal

Investigational Site Number 620004

Lisbon, Portugal

Investigational Site Number 620001

Lisbon, Portugal

Investigational Site Number 620003

Porto, Portugal

Investigational Site Number 642003

Brasov, Romania

Investigational Site Number 642004

Bucharest, Romania

Investigational Site Number 642002

Bucharest, Romania

Investigational Site Number 642006

Bucharest, Romania

Investigational Site Number 642001

Timișoara, Romania

Investigational Site Number 643009

Moscow, Russia

Investigational Site Number 643001

Moscow, Russia

Investigational Site Number 643010

Nizhny Novgorod, Russia

Investigational Site Number 643008

Petrozavodsk, Russia

Investigational Site Number 643005

Saint Petersburg, Russia

Investigational Site Number 643004

Saint Petersburg, Russia

Investigational Site Number 643007

Volgograd, Russia

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 410002

Bundang-Gu, South Korea

Investigational Site Number 410004

Seoul, South Korea

Investigational Site Number 410003

Seoul, South Korea

Investigational Site Number 410001

Seoul, South Korea

Investigational Site Number 410005

Seoul, South Korea

Investigational Site Number 410006

Seoul, South Korea

Investigational Site Number 410007

Seoul, South Korea

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 City, 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

Clinical Research Directory

Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (101)