Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis

Inclusion Criteria

• •Palpable splenomegaly at least 5 cm below the left costal margin
• •Confirmed diagnosis of PMF or post-PV/ET MF
• •Requires myelofibrosis therapy, in the opinion of the investigator
• •Classified as high risk OR intermediate-2 risk as defined by the International Prognostic Scoring System (IPSS) for PMF, or intermediate-1 risk (IPSS) associated with symptomatic splenomegaly, hepatomegaly, anemia (hemoglobin \< 10.0 g/dL), and/or unresponsive to available therapy
• •Acceptable laboratory assessment obtained within 14 days prior to the first dose of study drug:
• •* Absolute neutrophil count (ANC) ≥ 0.75 x 10\^9/L in the absence of growth factor in the prior 7 days
• •* Platelet Count ≥ 50 x 10\^9/L (≥ 100 x 10\^9/L if aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] is ≥ 2 x the upper limit of the normal range \[ULN\]) in the absence of platelet transfusion(s) or thrombopoietin mimetics in the prior 7 days
• •* Peripheral blood blast count \< 10%
• •* AST and ALT ≤ 3 x ULN (≤ 5 x ULN if liver is involved by extramedullary hematopoiesis as judged by the investigator or if related to iron chelator therapy that was started within the prior 60 days)
• •* Calculated creatinine clearance (CrCL) of ≥ 45 mL/min
• •* Direct bilirubin ≤ 2.0 x ULN
• •Life expectancy of \> 24 weeks
• •Males and females of childbearing potential must agree to use protocol-specified method(s) of contraception
• •Females who are nursing must agree to discontinue nursing before the first dose of study drug
• •Able to understand and willing to sign the informed consent form