An Open-Label Phase 2 Study of Itacitinib (INCB039110) in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Subjects With Myelofibrosis
The purpose of this study is to evaluate the efficacy and safety of itacitinib combined with low-dose ruxolitinib or itacitinib alone in participants with myelofibrosis (MF).
• Cohort A only
• •Receiving ruxolitinib dose of less than 20 mg daily with no dose increase or no dose modification in the last 8 weeks before screening visit.
• Cohort B only
• •Must have had initial reduction in spleen on ruxolitinib treatment:
• Followed by documented evidence of progression in spleen length or volume OR
• Discontinued ruxolitinib for hematologic toxicities, after the initial reduction in spleen length or volume.
• All participants
• Confirmed diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis according to revised World Health Organization 2016 criteria.
• Must have palpable spleen of greater than or equal to (≥) 5 centimeter (cm) below the left subcostal margin on physical examination at the screening visit.
• Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
• Screening bone marrow biopsy specimen available or willingness to undergo a bone marrow biopsy at screening/baseline; willingness to undergo bone marrow biopsy at Week 24.
• Life expectancy of at least 24 weeks.
• Willingness to avoid pregnancy or fathering children