European Leukemia Trial Registry
Trial: ARD12042

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Public Title Study With SAR302503 in Patients With Polycythemia Vera or Essential Thrombocythemia
Scientific Title A Randomized Phase II, Open-Label Study of the Efficacy and Safety of Orally Administered SAR302503 in Patients With Polycythemia Vera (PV) or Essential Thrombocythemia (ET) Who Are Resistant or Intolerant to Hydroxyurea
Short Title ARD12042
Id KN/ELN LN_NN_2012_502
Trialgroup NN
Type of Trial randomized, open-label
Phase Phase II
Disease Myeloproliferative disease(MPD) Polycythaemia vera
Myeloproliferative disease(MPD) Essential Thrombocythaemia
Stage of Disease .
Inclusion Criteria
  • Has had a diagnosis of hydroxyurea resistant or intolerant polycythemia vera (PV) or essential thrombocythemia (ET)
  • Polycythemia vera or essential thrombocythemia defined according to the revised WHO criteria
  • Polycythemia vera resistance or intolerance to hydroxyurea is defined as polycythemia vera patients on hydroxyurea with a hematocrit >45%, or phlebotomy twice in the last 6 months and at least once in the last 3 months
  • Essential thrombocythemia resistance or intolerance to hydroxyurea is defined as essential thrombocythemia patients on hydroxyurea with platelet count >600 x 10x9/L
  • Provide written informed consent to participate
Exclusion Criteria
  • Less than 18 years of age
  • articipation in any study of an investigational agent (drug, biologic, device) within 30 days prior to initiation of study drug, unless during non-treatment phase. (Prior treatment with another JAK2 inhibitor is allowed.)
  • Unwilling to comply with scheduled visits, treatment plans, laboratory assessments, and other study-related procedures
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 3 or 4 at study entry
  • Splenectomy
  • Contraindications for undergoing magnetic resonance imaging (MRI) in patients with palpable spleens (eg, metal implants)
  • Any chemotherapy (eg, hydroxyurea), radiophosphorus therapy, immunomodulatory drug therapy (eg, interferon-alpha), corticosteroids >10 mg/day prednisone or equivalent or anagrelide within 14 days prior to initiation of study drug
  • Active malignancy other than polycythemia vera or essential thrombocythemia, except adequately treated basal cell carcinoma and squamous cell carcinoma of the skin, cervical carcinoma in situ, or other malignancies that have been stable and off therapy for >=5 years
  • Major surgery within 28 days or radiation within 3 months prior to initiation of study drug
  • Unable to swallow capsules
  • Active acute infection requiring antibiotics
  • Known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness
  • 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 study drug
  • Any severe acute or chronic medical, neurological, or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with interpretation of study results and, in the Investigator's opinion, would make the patient inappropriate for entry into this study
  • Inadequate organ function
  • Known active (acute or chronic) Hepatitis A, B, or C; and hepatitis B and C carriers C
  • Prior history of chronic liver disease (eg, chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemachromatosis, non-alcoholic steatohepatitis [NASH])
  • Concomitant treatment with or use of drugs or herbal agents known to be at least moderate inhibitors or inducers cytochrome P450 3A4 (CYP3A4)
  • Presence of any gastric or other disorder that would inhibit absorption of oral medication
  • Known hypersensitivity to any excipients in the study drug formulation
  • Pregnant or lactating female
  • Women of childbearing potential, unless using effective contraception while on study drug
  • Men who partner with a woman of childbearing potential, unless they agree to use effective contraception while on study drug
Age >= 18 years
Status Active
Start of Recruitment 01.04.2012
Recruiting Countries Germany
France
U.K.
Spain
Italy
Target Sample Size 90
Leader Hochhaus, Prof. Dr. med., Andreas
Shortprotocol Shortprotocol
Sponsors Sanofi
Other Registers ClinicalTrials.gov NCT01420783
European Clinical Trials Database - EUDRACT 2011-001847-58
created 01.10.2012 Sina Hehn
changed 08.05.2013 Sina Hehn
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