An Open Label Assessment of Once Daily Dosing of a Sustained Release (SR) Formulation of INCB018424 in Patients With Primary Myelofibrosis, Post Essential Thrombocythemia-Myelofibrosis and Post Polycythemia Vera-Myelofibrosis
The study will enroll approximately 40 subjects with PMF, PPV-MF or PET-MF. Subjects will
take INCB018424 SR (ruxolitinib SR)once daily for 16 consecutive weeks and then transition
to a comparable twice daily dose regimen of INCB018424 (ruxolitinib) using the immediate
release (IR) tablets which have been under investigation in controlled Phase 1, 2 and 3
The study is comprised of 4 phases:
Screening Baseline Treatment Phase (INCB018424 SR qd; 16 weeks) Extension Phase (INCB018424
Subjects receiving benefit from treatment with INCB018424 (ruxolitinib) may continue further
participation with IR tablets up to the time of marketing approval and commercial
availability of INCB018424 (ruxolitinib) tablets. Follow-up will occur at least 30 days
following the last dose of INCB018424 (ruxolitinib).
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in platelet count from Baseline to each visit where platelet count is measured during the treatment phase of the study.
Baseline and every 1-2 weeks through the Week 16 Visit or until early termination from the study.
Srdan Verstovsek, MD, PhD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|Phoenix, Arizona 85012|
|Miami, Florida 33176|
|Austin, Texas 78705|