Momelotinib in Transfusion-Dependent Adults With Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)
Condition: Primary Myelofibrosis (PMF); Post-polycythemia Vera (Post-PV) Myelofibrosis; Postessential Thrombocythemia (Post-ET) Myelofibrosis
MeSH terms: Polycythemia Vera; Primary Myelofibrosis; Polycythemia; Thrombocytosis; Thrombocythemia, Essential
Intervention: MMB
Intervention description: Momelotinib (MMB) tablet administered orally once daily
Intervention MeSH terms: N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the transfusion independence response rate in transfusion-dependent
      adults with myelofibrosis after treatment with momelotinib (MMB).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of PMF or Post PV/ET-MF

          -  Requires myelofibrosis therapy, in the opinion of the investigator

          -  High risk OR intermediate-2 risk defined by dynamic international prognostic scoring
             system (DIPSS) OR intermediate-1 risk defined by DIPSS and associated with symptomatic
             splenomegaly and/or hepatomegaly

          -  Transfusion dependent at baseline, defined as ≥ 4 U red blood cell (RBC) transfusion
             in the 8 weeks prior to first dose of MMB

          -  Acceptable organ function as evidenced by the following:

               -  Platelet Count ≥ 50 x 10^9/L

               -  Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 3
                  x upper limit of normal (ULN) or AST or ALT ≤ 5 x ULN if liver is involved by
                  disease process as judged by the investigator

               -  Serum creatinine ≤ 2.0 mg/dL or calculated creatinine clearance of ≥ 60 mL/min

               -  Direct bilirubin ≤ 2.0 x ULN

          -  Life expectancy of > 24 weeks

          -  Males and females of childbearing potential who engage in heterosexual intercourse
             must agree to use protocol specified method(s) of contraception

          -  Lactating females must agree to discontinue nursing before MMB administration

          -  Able to understand and willing to sign the informed consent form

        Key Exclusion Criteria:

          -  Prior splenectomy

          -  Splenic irradiation within 3 months prior to the first dose of MMB

          -  Prior treatment with MMB

          -  Known positive status of human immunodeficiency virus (HIV)

          -  Chronic active or acute viral hepatitis A, B, or C infection (testing required for
             hepatitis B and C), or hepatitis B or C carrier

          -  Use of strong cytochrome P450 3A4 (CYP3A4) inducer within 2 weeks prior to the first
             dose of MMB

          -  Uncontrolled intercurrent illness per protocol

          -  Treatment with a Janus kinase (JAK) inhibitor within 21 days of the planned first dose
             of MMB

          -  Presence of peripheral neuropathy ≥ Common Terminology Criteria for Adverse Events
             (CTCAE) Grade 2

          -  Unwilling or unable to undergo a MRI per requirements in the study protocol

          -  Unwilling to consent to genomics sampling

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.