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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hematopoietic Neoplasm

In brief

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.

Key facts

Study ID

NCT01437787

Run by

Bristol-Myers Squibb

People needed

289

Starts

2011-12-01

Expected to finish

2014-06-01

Last updated by the study team

2025-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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 840014 — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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