Phase 3 Study of SAR302503 in Intermediate-2 and High risk patients with Myelofibrosis

• Conditions: Primary myelofibrosis, post-polycythemia vera myelofibrosis, or post- essential thrombocythemia myelofibrosis; MedDRA version: 15.1Level: LLTClassification code 10018864Term: Haematopoietic neoplasm NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2011-001897-25-LT
• Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-05
• Last Update Posted: 30 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 225

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.
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 112
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 113

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
Subjects 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])

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified