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

NCT01523171

TerminatedPhase 2

Sponsor: Bristol-Myers Squibb

Conditions: Hematopoietic Neoplasm

Interventions: SAR302503

Countries: United States, Austria, Belgium, Canada, France, Germany, Italy, Netherlands

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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

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 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.
Locations (42)
  • Phoenix, Arizona, United States
  • San Francisco, California, United States
  • San Francisco, California, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Kansas City, Kansas, United States
  • Baltimore, Maryland, United States
  • Baltimore, Maryland, United States
  • Ann Arbor, Michigan, United States
  • New York, New York, United States
  • New York, New York, United States
  • Cleveland, Ohio, United States
  • Middletown, Ohio, United States
  • Charleston, South Carolina, United States
  • Houston, Texas, United States
  • Salt Lake City, Utah, United States
  • Salzburg, Austria
  • Vienna, Austria
  • Antwerp, Belgium
  • Leuven, Belgium
  • Toronto, Canada
  • Marseille, France
  • Nîmes, France
  • Paris, France
  • Paris, France
  • Toulouse, France
  • Frankfurt am Main, Germany
  • Leipzig, Germany
  • Magdeburg, Germany
  • Mannheim, Germany
  • + 12 more on CT.gov