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• Conditions: Hematopoietic neoplasm; MedDRA version: 16.1Level: LLTClassification code 10018864Term: Haematopoietic neoplasm NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2011-005226-21-NL
• Lead Sponsor: Sanofi-aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-09
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

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 (exposure of <14 days is allowed for subjects who discontinued
Ruxolitinib due to intolerability or allergy) and discontinued the treatment for at least 14 days prior to the first dose of SAR302503
MF classified as Intermediate-1 with symptoms, Intermediate-2 or high-risk by Dynamic
International Prognostic Scoring System (Passamonti et al., Blood 2010)
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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

Splenectomy
Eastern Cooperative Oncology Group (ECOG) performance status of >2 before the first dose of SAR302503 at Cycle 1 Day1
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
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =2.5 xULN
Total bilirubin =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
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])
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, 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.The only chemotherapy allowed will be hydroxyurea within 1 day 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