A Phase 2, Open-label, Randomized Study to Evaluate the Safety and Efficacy of Momelotinib in Subjects With Polycythemia Vera or Essential Thrombocythemia

Location:

Phoenix/Scottsdale, Ariz.

Trial status:

Open for Enrollment

Why is this study being done?

This open-label study is to determine the safety and efficacy of momelotinib in participants with either polycythemia vera (PV) or essential thrombocythemia (ET) who have not yet received treatment with a Janus kinase (JAK) inhibitor.

Who is eligible to participate?

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 inhibitors or strong inducers CYP3A4 within 1 week prior to the first dose of study drug - QTc interval > 450 msec, unless attributed to bundle branch block

Last updated:

7/28/2014

NCT ID:

NCT01998828

IRB Number:

14-000756