Phase II, Open Label, Single Arm Study of SAR302503 In Myelofibrosis Patients Previously Treated With Ruxolitinib

Stopped early · Phase 2

Conditions studied: Hematopoietic Neoplasm

In brief

Primary Objective: \- To evaluate the efficacy of once daily dose of SAR302503 in subjects previously treated with ruxolitinib and with a current diagnosis of intermediate-1 with symptoms, Intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (Post-PV MF), or post-essential thrombocythemia myelofibrosis (Post-ET MF) based on the reduction of spleen volume at the end of 6 treatment cycles; Secondary Objectives: * To evaluate the effect of SAR302503 on Myelofibrosis (MF) associated symptoms as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary * To evaluate the durability of splenic response * To evaluate the splenic response to SAR302503 by palpation at the end of Cycle 6 * To evaluate the splenic response to SAR302503 at the end of Cycle 3 * To evaluate the effect of SAR302503 on the Janus kinase 2 (JAK2) V617F allele burden * To evaluate the safety and tolerability of SAR302503 in this population * To evaluate plasma concentrations of SAR302503 for population PK analysis, if warranted

Key facts

Study ID

NCT01523171

Run by

Bristol-Myers Squibb

People needed

97

Starts

2012-04-30

Expected to finish

2014-04-30

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 x ULN
• 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
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 840007 — Phoenix, Arizona, United States
• Investigational Site Number 840003 — San Francisco, California, United States
• Investigational Site Number 840004 — San Francisco, California, United States
• Investigational Site Number 840005 — Atlanta, Georgia, United States
• Investigational Site Number 840014 — Chicago, Illinois, United States
• Investigational Site Number 840001 — Kansas City, Kansas, United States
• Investigational Site Number 840017 — Baltimore, Maryland, United States
• Investigational Site Number 840013 — Baltimore, Maryland, United States
• Investigational Site Number 840010 — Ann Arbor, Michigan, United States
• Investigational Site Number 840009 — New York, New York, United States
• Investigational Site Number 840018 — New York, New York, United States
• Investigational Site Number 840022 — Cleveland, Ohio, United States
• Investigational Site Number 840019 — Middletown, Ohio, United States
• Investigational Site Number 840024 — Charleston, South Carolina, United States
• Investigational Site Number 840002 — Houston, Texas, United States
• Investigational Site Number 840015 — Salt Lake City, Utah, United States
• Investigational Site Number 040002 — Salzburg, Austria
• Investigational Site Number 040001 — Vienna, Austria
• Investigational Site Number 056002 — Antwerp, Belgium
• Investigational Site Number 056003 — Leuven, Belgium
• Investigational Site Number 124001 — Toronto, Canada
• Investigational Site Number 250001 — Marseille, France
• Investigational Site Number 250003 — Nîmes, France
• Investigational Site Number 250002 — Paris, France
• Investigational Site Number 250006 — Paris, France

Full record on ClinicalTrials.gov

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