Clinical Trials

Inclusion Criteria

• Diagnosis of polycythemia vera (PV), essential thrombocythemia (ET), or myelofibrosis (MF) as defined by the World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms and meet additional sub-type specific criteria
• For PV, has failed or is intolerant of standard therapies or refuses to take standard medications
• For ET, has failed or is intolerant of standard therapies or refuses to take standard medications
• For MF, must meet at least one of the following
  • Has intermediate or high-risk MF according to the Lille scoring system
  • Has symptomatic MF with spleen greater than 10 cm below left costal margin
  • Has post-polycythemic MF
  • Has post-ET MF
• Has a quantifiable JAK2 V617F mutation
• Has discontinued all previous approved therapies for at least 14 days and recovered from the acute effects of therapy for myeloproliferative disorders, including any
  • Chemotherapy
  • Immunomodulating therapy (for example, thalidomide, interferon-alpha)
  • Immunosuppressive therapy (for example, corticosteroids greater than 10 mg/day prednisone or equivalent)
  • Radiotherapy
  • Erythropoietin, thrombopoietin, or granulocyte colony stimulating factor
• Hydroxyurea used to control blood cell counts is permitted at study entry if there has been a stable dose for at least 4 weeks.
• Low-dose acetylsalicylic acid (aspirin) is permitted as well

Exclusion Criteria

• Has received treatment within 14 days of the initial dose of study drug with an experimental agent that has not received regulatory approval for any indication
• Currently being treated with agents that are metabolized by CYP3A4 with a narrow therapeutic margin (for example, alfentanil, cyclosporine, diergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus) or CYP2B6 (for example, cyclophosphamide, ifosfamide, tamoxifen, efavirenz, propofol, methadone, and bupropion)
• Currently being treated with warfarin or one of its derivatives which is known to alter levels of protein C or protein S
  • An exception to this will be allowed for a prior history of Budd-Chiari Syndrome being treated with warfarin or one of its derivatives