Safety and Efficacy of Momelotinib in Subjects With Polycythemia Vera or Essential Thrombocythemia

Inclusion Criteria:

Diagnosis of either PV or ET as defined by the 2008 World Health Organization (WHO) Diagnostic Criteria
Requires treatment for PV or ET, in the opinion of the study investigator
Intolerant of, resistant to, or refuses current or available treatment for PV or ET
Direct bilirubin ≤ 2.0 x upper limit of the normal range (ULN)
Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN
Calculated creatinine clearance (CrCl) of ≥ 45 mL/min
Life expectancy > 24 weeks
Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse 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 comprehend and willing to sign informed consent form

Exclusion Criteria:

Prior splenectomy
Uncontrolled intercurrent illness, per protocol
Known positive status for human immunodeficiency virus (HIV)
Chronic active or acute viral hepatitis A, B, or C infection, or hepatitis B or C carrier
Myeloproliferative neoplasm-directed therapy, other than aspirin, hydroxyurea, anagrelide, and/or phlebotomy, within 21 days prior to the first dose of study drug
Anagrelide within 7 days prior to the first dose of study drug
Presence of peripheral neuropathy ≥ Grade 2
Unwilling or unable to take oral medication
Prior use of a JAK1 or JAK2 inhibitor
Use of strong CYP3A4 inducers within 1 week prior to the first dose of study drug
QTc interval > 450 msec, unless attributed to bundle branch block