Study of SB939 in Subjects With Myelofibrosis
Condition: Myeloproliferative Disorders
MeSH terms: Polycythemia Vera; Primary Myelofibrosis; Polycythemia; Myeloproliferative Disorders
Intervention: SB939
Intervention description: Starting dose 60 mg by mouth every other day, three times weekly for 3 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Primary Polycythemia Vera; Post Polycythemia Vera; Post Essential Thrombocythemia Myelofibrosis; SB939; PMF; post-PV MF; post-ET MF

Summary:

      The goal of this clinical research study is to learn if SB939 can help to control
      myelofibrosis. The safety of this drug will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must be equal to or greater than 18 years of age

          2. Must be diagnosed with Primary Myelofibrosis (PMF) or Post-Essential Thrombocythemia
             (ET) Myelofibrosis (MF) Post-Polycythemia Vera (PV) MF with intermediate-1,
             intermediate -2 or high risk disease according to the International Working Group
             (IWG) prognostic scoring system, or if with low risk disease then with symptomatic
             splenomegaly that is equal to or greater than 5 cm below left costal margin by
             physical exam.

          3. Must have adequate organ function as demonstrated by the following: • alanine
             aminotransferase (ALT) (SGOT) and/or aspartate aminotransferase (AST) (SGPT) equal to
             or less than 2.5 times upper limit of normal (ULN), [unless upon judgment of the
             treating physician, it is believed to be due to extramedullary hematopoiesis (EMH)
             related to MF] • Total bilirubin equal to or less than 1.5 times ULN • Serum
             creatinine equal to or less than 2.5 mg/dL

          4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2

          5. At least 2 weeks from prior MF-directed treatment (till the start of study drug)

          6. Treatment-related toxicities from prior therapies must have resolved to Grade equal to
             or less than 1

          7. No other active malignancies.

          8. Females of childbearing potential (a sexually mature woman who: 1) has not undergone a
             hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal
             for at least 24 consecutive months (i.e., has had menses at any time in the preceding
             24 consecutive months)).must have negative pregnancy test.

        Exclusion Criteria:

          1. Prolongation of the QTc interval to >470 msec at baseline ECG

          2. Known positive status for HIV, or known active hepatitis A, B, or C infection.

          3. Any serious medical condition or psychiatric illness that would prevent, (as judged by
             the treating physician) the subject from signing the informed consent form or any
             condition, including the presence of laboratory abnormalities, which places the
             subject at unacceptable risk if he/she were to participate in the study or confounds
             the ability to interpret data from the study.

          4. Pregnant or lactating females.

          5. Current use of drugs known to prolong QTc interval.