A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKaryopharm Therapeutics Inc
About this trial
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 criteria
Qualifiers
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 (<=) 2
Disqualifiers
More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase)
Previous treatment with JAK inhibitors for MF
Previous treatment with selinexor or other XPO1 inhibitors
Females who are pregnant or lactating
Trial design
Treatments tested in this trial
- Selinexor 60 mg
- Selinexor 40 mg
- Ruxolitinib
- Pacritinib
- Momelotinib
Treatment groups
58 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov