Study of SAR302503 in Subjects with a Current Diagnosis of Intermediate-2 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

• Conditions: Hematopoietic neoplasm; MedDRA version: 14.1Level: LLTClassification code 10018864Term: Haematopoietic neoplasm NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2011-005226-21-IT
• Lead Sponsor: SANOFI- AVENTIS RECHERCHE ET DÉVELOPPEMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-25
• Last Update Posted: 30 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Diagnosis of PMF or Post-PV MF or Post-ET MF, according to the 2008 World Health Organization and IWG-MRT response criteria Subjects who previously received Ruxolitinib treatment for PMF or Post- PV MF or Post-ET MF or PV or ET for at least 14 days and discontinued the treatment for at least 30 days prior to study entry MF classified as high-risk or intermediate-risk level 2 (IWG-MRT response criteria IPSS assess myelofibrosis score, Cervantes, et al, Blood 2009) Spleen =5 cm below costal margin as measured by palpation Male and female subjects =18 years of age Signed written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

Exclusion Criteria

Splenectomy Eastern Cooperative Oncology Group (ECOG) performance status of >2 at study entry The following laboratory values within 14 days prior to the initiation of SAR302503: 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 Direct bilirubin =3.0 x ULN and subjects with total bilirubin between 1.5- 3.0 x ULN must be excluded if the direct bilirubin fraction is =25% of the total Subjects with known active (acute or chronic) Hepatitis A, B, or C; and Hepatitis B and C carriers Prior history of chronic liver disease (eg, chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemachromatosis, non-alcoholic steatohepatitis [NASH]) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) = 2.5 x ULN Subjects with any other prior malignancies are not eligible, except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which subject has been disease-free for at least 5 years 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 SAR302503; darbepoetin use within 28 days prior to initiation of SAR302503 Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of SAR302503

Study & Design

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