Study of INCB053914 in Subjects With Advanced Malignancies

Inclusion Criteria

• •Aged 18 years or older
• •Confirmed diagnosis of select advanced malignancy
• •Parts 1 and 2:
• •* Unresponsive to currently available therapy and there is no standard-of-care therapy available in the judgment of the investigator.
• •* Not currently a candidate for curative treatment
• •Parts 3 and 4:
• •* Subjects with relapsed/refractory AML must have received either induction chemotherapy for AML or hypomethylating agents for hematologic disease before AML.
• •* Elderly subjects (≥ 65 years) with newly diagnosed AML must be treatment naive and unfit for intensive chemotherapy.
• •* Myelofibrosis subjects must have been treated with ruxolitinib for ≥ 6 months with a stable dose for ≥ 8 weeks (acceptable doses are 5 mg twice daily \[BID\] to 25 mg BID).
• •Willingness to undergo a pretreatment bone marrow biopsy and/or aspirate, or archival sample obtained since completion of most recent therapy (as appropriate to subjects with existing bone marrow disease or for whom bone marrow examination is a component of disease status assessment)
• •Eastern Cooperative Oncology Group (ECOG) performance status
• •* Part 1: 0 or 1
• •* Parts 2, 3 and 4: 0, 1, or 2
• •Life expectancy \> 12 weeks or ≥ 24 weeks for Part 3 and Part 4 MF subjects.