This is a study of itacitinib (INCB039110) in patients with myelofibrosis. This study will evaluate safety and efficacy parameters of itacitinib (INCB039110).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
87
Birmingham Hematology Oncology Associates, LLC
Birmingham, Alabama, United States
Proportion of subjects with >/= 50% reduction in total symptom score in each dose group, as measured by the modified The Myelofibrosis Symptom Assessment Form (MFSAF) v3.0 diary
Time frame: Baseline and Week 12
Proportion of subjects with >/= 35% reduction in spleen volume, and mean percent change in spleen volume
Time frame: Baseline, Week 12 and Week 24
Proportion of transfusion dependent subjects who exhibit changes in transfusion frequency over any 12 week period on study and proportion of transfusion independent subjects who exhibit changes in hemoglobin level
Time frame: Baseline to Week 12; Week 13 to Week 24 through the end of study or study termination visit.
Safety and tolerability of itacitinib as measured by adverse events.
Time frame: Every 4-6 weeks through the end of study or early termination visit (approximately 33 weeks exclusive of the extension phase).
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