Status:
COMPLETED
Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hematopoietic Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 de...
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 Tre...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
289 Patients enrolled
Trial Details
Trial ID
NCT01437787
Start Date
December 1 2011
End Date
June 1 2014
Last Update
March 5 2025
Active Locations (101)
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1
Investigational Site Number 840014
Scottsdale, Arizona, United States, 85259-5499
2
Investigational Site Number 840001
La Jolla, California, United States, 92093
3
Investigational Site Number 840012
La Jolla, California, United States, 92093
4
Investigational Site Number 840006
Los Angeles, California, United States, 90033