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

Phase 1

• Conditions: Hematopoietic neoplasm; MedDRA version: 20.1 Level: LLT Classification code 10018864 Term: Haematopoietic neoplasm NOS System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-09
• Study Completion: 2014-04-29
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 97

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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 >2.0 x ULN
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 x ULN; higher values (ie, >5 x ULN) are allowed if clinically compatible with hepatic extramedullary hematopoiesis
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