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A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia

ConditionsMyelofibrosisModerate ThrombocytopeniaMild 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Selinexor 60 mg

    Drug

    Participants will receive selinexor 60 mg oral tablets QW.

  • Selinexor 40 mg

    Drug

    Participants will receive selinexor 40 mg oral tablets QW.

  • Ruxolitinib

    Drug

    Participants will receive ruxolitinib per local package insert.

  • Pacritinib

    Drug

    Participants will receive pacritinib per local package insert. For countries where not approved, 200 mg twice daily is the starting dose.

  • Momelotinib

    Drug

    Participants will receive momelotinib per local package insert.

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: Selinexor 60 mg (Arm 1)Experimental treatment 4 interventions
Group B: Selinexor 40 mg (Arm 2)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Proportion of Participants with Spleen Volume Reduction ≥35% (SVR35) at Week 24

Measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) Scan by Investigator assessment.

Time frame
At Week 24

Secondary outcomes

1

Absolute Mean Change in Total Symptom Score (Abs-TSS) from baseline to Week 24

Measured by the Myelofibrosis Symptom Assessment Form (MFSAF) V4.0.

Time frame
At Baseline and Week 24
2

Incidence and severity of TEAEs, including TRAEs and SAEs

Measured by the NCI CTCAE Grading Scale, v. 5, as assessed and graded by the Investigator

Time frame
From Baseline to EoS (approximately 48 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karyopharm Therapeutics Inc

Lead sponsor

Source ClinicalTrials.gov
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