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

NCT05980806 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-02-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Selinexor 60 mg

Participants will receive selinexor 60 mg oral tablets QW.

DRUG

Selinexor 40 mg

Participants will receive selinexor 40 mg oral tablets QW.

DRUG

Ruxolitinib

Participants will receive ruxolitinib per local package insert.

DRUG

Pacritinib

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

DRUG

Momelotinib

Participants will receive momelotinib per local package insert.

Sponsors & Collaborators

  • Karyopharm Therapeutics Inc

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-22
Primary Completion
2027-06-30
Completion
2028-10-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Romania
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05980806 on ClinicalTrials.gov