EUCTR2011-005226-21-ITActive, not recruitingNot Applicable
A Phase II, Multicenter, Open Label, Single Arm Study of SAR302503 in Subjects Previously Treated with Ruxolitinib and with a Current Diagnosis of Intermediate-2 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis
SANOFI- AVENTIS RECHERCHE ET DÉVELOPPEMENT0 sites41 target enrollmentStarted: October 25, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 41
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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