5312W-12: Milder Lilly JHTA

CRC 11122: A Phase 2 Study of LY2784544 in Patients with Myeloproliferative Neoplasms

Type of Study
Cancer (Oncology) - Myeloproliferative Disorders
Location
Swedish Cancer Institute
Short Description

Purpose: The primary purpose of this study is to measure the response rate in participants with the myeloproliferative neoplasms (MPNs), polycythemia vera (PV), essential thrombocythemia (ET), or myelofibrosis (MF) when treated with LY2784544.

Status
Open to Enrollment
Principal Investigator
Michael Milder, M.D.
Eligibility Notes
  • Have a diagnosis of polycythemia vera (PV), essential thrombocythemia (ET), or myelofibrosis (MF) as defined by the World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms (Swerdlow et al. 2008) and meet the following additional subtype specific criteria:
    • PV: have failed or is intolerant of standard therapies or refuses to take standard medications
    • ET: have failed or is intolerant of standard therapies or refuses to take standard medications
    • MF (patients with MF must meet at least 1 of the following): have intermediate 1, intermediate 2, or high-risk MF according to the Dynamic International Prognostic Scoring System (DIPPS Plus) for Primary Myelofibrosis (Gangat et al. 2011); or have symptomatic MF with spleen greater than 10 cm below left costal margin; or have post-polycythemic MF; or have post-ET MF
  • All PV, ET, and MF patients must meet the following criteria:
    • Have a quantifiable level of janus kinase 2 with a valine to phenylalanine substitution at amino acid 617 (JAK2 V617F) mutation. For patients in Dose Level 3, this inclusion criterion will not apply to the subset of patients in Cohorts 10 and 11 that are required to be negative for the JAK2 V617F mutation. This subset of patients must be negative for the mutation with unquantifiable levels of JAK2 V617F
  • ECOG performance status 0-2
  • Must be able to swallow capsules
  • No corrected QT (QTc) interval > 470 millisecond (msec)
  • No prior hematopoietic stem cell transplant
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
Phone
(206) 215-3086
Email
CancerResearch@swedish.org