A Phase 1/2 , Open-Label Study of the JAK2 Inhibitor INCB018424 Administered Orally to Patients With Primary Myelofibrosis (PMF) and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis (Post-PV/ET)
This is a multicenter, open-label, non-randomized, dose escalation study of ruxolitinib, a
small molecule Janus kinase (JAK) inhibitor, administered orally to patients with PMF,
PPEV-MF or PET-MF. The study is comprised of 3 parts:
Part 1: Dose escalation and determination of maximum tolerated dose (complete).
Part 2: Exploration of alternative dosing schedules (ongoing).
Part 3: Further evaluation of selected dose regimens, including additional response
measures to explore effect of ruxolitinib on symptoms and other parameters including daily
physical activity and long-term survival (ongoing).
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Adverse Events (AEs)
Treatment-Emergent AEs are events occurring after first drug administration or worsened from baseline. Treatment-Related AEs are those with a definite, probable, possible or missing causality. A serious AE is a medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is a medical event requiring intervention to prevent 1 of the above. A severe or life-threatening AE is based on intensity, according to NCI-CTCAE v3.0.
From Baseline to the interim clinical cut-off date (31 December 2009). The median time on study was 14.8 months, with a range of 26 days to 29.7 months. As of March 1, 2011 the total exposure to ruxolitinib was 269 patient-years.
Srdan Verstovsek, MD, PhD
M.D. Anderson Cancer Center, Houston, TX
United States: Food and Drug Administration
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