NCT05980806

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

A Phase 2 Study to Evaluate the Efficacy and Safety of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Karyopharm Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Myelofibrosis
• Moderate Thrombocytopenia
• Mild Thrombocytopenia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-22
• Primary completion: 2027-06-01
• Completion: 2028-10-01
• First posted: 2023-08-08
• Last updated: 2026-02-12

Locations

70 sites across 19 countries: United States, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, Poland, Romania, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study