Safety and Efficacy of Momelotinib in Subjects With Polycythemia Vera or Essential Thrombocythemia
Polycythemia Vera, Essential Thrombocythemia
About this trial
This is an interventional treatment trial for Polycythemia Vera focused on measuring Polycythemia, Polycythemia Vera, Essential Thrombocythemia, Thrombocytosis, Myeloproliferative Disorders, Bone Marrow Diseases, Hematologic Diseases, Blood Coagulation Disorders, Blood Platelet Disorders, Hemorrhagic Disorders
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Momelotinib 100 mg PV
Momelotinib 200 mg PV
Momelotinib 100 mg ET
Momelotinib 200 mg ET
Participants with polycythemia vera will receive 100 mg of momelotinib.
Participants with polycythemia vera will receive 200 mg of momelotinib.
Participants with essential thrombocythemia will receive 100 mg of momelotinib.
Participants with essential thrombocythemia will receive 200 mg of momelotinib.