EUCTR2011-005226-21-BEActive, 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 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis - JAKARTA2
Sanofi-aventis Recherche & Développement0 sites70 target enrollmentStarted: September 15, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 70
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 (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
- •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
Investigators
Similar Trials
Active, not recruiting
Not 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 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis - JAKARTA2Hematopoietic neoplasmMedDRA version: 14.1Level: LLTClassification code 10018864Term: Haematopoietic neoplasm NOSSystem Organ Class: 100000004864EUCTR2011-005226-21-ATSanofi-aventis Recherche & Développement70
Active, not recruiting
Not Applicable
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 MyelofibrosisHematopoietic neoplasmMedDRA version: 14.1Level: LLTClassification code 10018864Term: Haematopoietic neoplasm NOSSystem Organ Class: 100000004864EUCTR2011-005226-21-ITSANOFI- AVENTIS RECHERCHE ET DÉVELOPPEMENT41
Active, not recruiting
Not 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 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis - JAKARTA2EUCTR2011-005226-21-DESanofi-aventis Recherche & Développement70
Active, not recruiting
Not Applicable
ot applicableHematopoietic neoplasmMedDRA version: 16.1Level: LLTClassification code 10018864Term: Haematopoietic neoplasm NOSSystem Organ Class: 100000004864EUCTR2011-005226-21-NLSanofi-aventis Recherche & Développement70
Active, not recruiting
Phase 1
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 MyelofibrosisHematopoietic neoplasmMedDRA version: 20.1 Level: LLT Classification code 10018864 Term: Haematopoietic neoplasm NOS System Organ Class: 100000004864EUCTR2011-005226-21-GBSanofi-aventis Recherche & Développement97