A Study of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis

Exclusion Criteria

• •Use of experimental drug therapy for myelofibrosis, or any other standard drug (eg, danazol, hydroxyurea, etc) with the exception of ruxolitinib within 6 months of starting study (combination) therapy and/or lack of recovery from all toxicities from previous therapy (except ruxolitinib) to Grade 1 or better
• •Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications
• •Unwillingness to be transfused with blood components
• •Recent history of inadequate bone marrow reserve as demonstrated by the following:
• •* Platelet count \< 50 × 10\^9/L in the 4 weeks before screening or platelet transfusion(s) within 8 weeks before screening
• •* Absolute neutrophil count levels \< 0.5 × 10\^9/L in the 4 weeks before screening
• •* Subjects with peripheral blood blast count of \> 10% at the screening or baseline hematology assessments
• •* Subjects who are not willing to receive red blood cell (RBC) transfusions to treat low hemoglobin levels
• •Inadequate liver function at screening as demonstrated by the following:
• •* Direct bilirubin ≥ 2.0 × the upper limit of laboratory normal (ULN). (NOTE: direct bilirubin will only be determined if total bilirubin is ≥ 2.0 × ULN)
• •* alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 × ULN
• •Inadequate renal function at screening as demonstrated by creatinine clearance \< 50 mL/min or glomerular filtration rate \< 50 mL/min/1.73 m\^2