A Study of LY2784544 for Patients with Myeloproliferative Disorders

Overview

About this study

The purpose of this study is to find out the safe dose range of the study drug in patients who have myeloproliferative disorders.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Ruben Mesa, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions