Status:
COMPLETED
Phase II, Open Label, Single Arm Study of SAR302503 In Myelofibrosis Patients Previously Treated With Ruxolitinib
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hematopoietic Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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, Intermedia...
Detailed Description
The expected duration of the treatment in this study is approximately 8 months, based on a maximum 28-day screening period, followed by a 6-month (6-cycle) treatment period, and an EOT visit for subje...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT01523171
Start Date
April 1 2012
End Date
April 1 2014
Last Update
March 5 2025
Active Locations (42)
Enter a location and click search to find clinical trials sorted by distance.
1
Investigational Site Number 840007
Phoenix, Arizona, United States, 85054
2
Investigational Site Number 840003
San Francisco, California, United States, 94143
3
Investigational Site Number 840004
San Francisco, California, United States, 94143
4
Investigational Site Number 840005
Atlanta, Georgia, United States, 30322