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

The purpose of this study is to evaluate the safety, tolerability, and efficacy of the
combination of INCB050465 and ruxolitinib in subjects with myelofibrosis.

Eligibility Criteria

Inclusion Criteria:

- Diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or
post-essential thrombocythemia myelofibrosis

- Palpable spleen of > 10 cm below the left subcostal margin on physical examination at
the screening visit OR

- Palpable splenomegaly of 5 to 10 cm below left subcostal margin on physical exam AND
active symptoms of MF at the screening visit as demonstrated by presence of 1 symptom
score ≥ 5 or 2 symptom scores ≥ 3 using the Screening Symptom Form

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

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 and baseline visits as demonstrated by the

- 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 and baseline visits as demonstrated by
creatinine clearance < 50 mL/min or glomerular filtration rate < 50 mL/min/1.73 m^2

Principal Investigator

Albert Assad, MD

Study Contact

Incyte Corporation Call Center, 1.855.463.3463

Estimated Completion Date

Friday, December 1, 2017

ClinicalTrials.gov #