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

• Status: Terminated
• Trial end date: 2015-05-07
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences; Sierra Oncology, Inc.
• Treatments: N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide

Criteria

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