A Phase 2 Study to Evaluate the Efficacy and Safety of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia
Karyopharm Therapeutics Inc
Summary
The main purpose of this study is to evaluate the efficacy of selinexor in JAKi-naïve participants with myelofibrosis (MF) and with normal platelet counts or with mild to moderate thrombocytopenia based on spleen volume reduction (SVR). Additional efficacy and safety parameters will also be assessed during the study.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * A diagnosis of MF or post-ET or post-PV MF according to the 2016 World Health Organization (WHO) classification of MPN, confirmed by the most recent local pathology report * Measurable splenomegaly during the screening period as demonstrated by spleen volume of greater than or equal to (\>=) 450 cubic square centimeter (cm\^3) by MRI or CT scan (results from MRI or CT imaging performed within 28 days prior to C1D1 are acceptable) * DIPSS risk category of intermediate-1 with symptoms, or intermediate-2, or high-risk * ECOG Performance Status less than or equal to (\<=…
Interventions
- DrugSelinexor 60 mg
Participants will receive selinexor 60 mg oral tablets QW.
- DrugSelinexor 40 mg
Participants will receive selinexor 40 mg oral tablets QW.
- DrugRuxolitinib
Participants will receive ruxolitinib per local package insert.
- DrugPacritinib
Participants will receive pacritinib per local package insert. For countries where not approved, 200 mg twice daily is the starting dose.
- DrugMomelotinib
Participants will receive momelotinib per local package insert.
Locations (70)
- City of Hope - Duarte Main SiteDuarte, California
- Maryland Oncology Hematology - Independent of SCRI/ US OncologyColumbia, Maryland
- Weill Cornell Medicine NewYork-PresbyterianNew York, New York
- Duke UniversityDurham, North Carolina
- Cleveland ClinicCleveland, Ohio
- MD AndersonHouston, Texas