Recruiting
Phase 2

Selinexor

Sponsor:

Karyopharm Therapeutics Inc

Code:

NCT05980806

Conditions

Myelofibrosis

Moderate Thrombocytopenia

Mild Thrombocytopenia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Selinexor 60 mg

Selinexor 40 mg

Ruxolitinib

Pacritinib

Momelotinib

Study Details

Brief 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

Study ID

NCT05980806

Start date

Apr 22, 2024

Status verified date

Feb, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 (<=) 2
  • Platelet count of greater than or equal to (>=) 50 x 10\^9/L without platelet transfusion within 7 days prior to the first dose of selinexor
  • Absolute neutrophil count (ANC) >=1.0 × 10\^9/L without need for growth factors within 7 days prior to the first dose of selinexor
  • Adequate liver function as defined by the following: aspartate transaminase (AST) and alanine transaminase (ALT) <= 2.5 × upper limit normal (ULN) and serum total bilirubin <= 3×ULN
  • Calculated creatinine clearance (CrCl) greater than (>) 15 milliliter per minute (mL/min) based on the Cockcroft and Gault formula
  • Active symptoms of MF as determined by presence of at least 2 symptoms with an average score >= 5 or total score of >= 12 at screening (at least 5 of 7 consecutive days immediately preceding C1D1) using the MFSAF V4.0
  • Must provide bone marrow biopsy samples (samples obtained up to 3 months prior to C1D1 are permitted) at screening and during the study
  • Currently not eligible for stem cell transplantation
  • Must be willing to complete the MFSAF V4.0 daily during the study for evaluating the symptom response (i.e., TSS50)

Key Exclusion Criteria:

  • 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
  • Prior splenectomy, splenic radiation, or a splenic embolization within 6 months prior to C1D1
  • History of myocardial infarction, unstable angina, percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG), cerebrovascular accident (transient ischemic attack \[TIA\]), ventricular arrhythmias, congestive heart failure class > 2 per New York Heart Association (NYHA) within 6 months of C1D1
  • Unable to tolerate two forms of antiemetics prior to each dose for the first two cycles

Study Design

Enrollment

58 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Selinexor 60 mg (Arm 1)

Participants will receive selinexor 60 milligrams (mg) oral tablets once weekly (QW) (Days 1, 8, 15, and 22 of each 28-day cycle) until PD, intolerable toxicity, or until they meet the criteria for discontinuation of study treatment. Optional add-on medication dosing may be initiated based on Spleen Volume Reduction (SVR) values at Week 12 or Week 24 of treatment.

experimental: Selinexor 40 mg (Arm 2)

Participants will receive selinexor 40 mg oral tablets QW (Days 1, 8, 15, and 22 of each 28-day cycle) until PD, intolerable toxicity, or until they meet the criteria for discontinuation of study treatment. Optional add-on medication dosing may be initiated based on Spleen Volume Reduction (SVR) values at Week 12 or Week 24 of treatment.

Interventions

Selinexor 60 mg

Participants will receive selinexor 60 mg oral tablets QW.

Selinexor 40 mg

Participants will receive selinexor 40 mg oral tablets QW.

Ruxolitinib

Participants will receive ruxolitinib per local package insert.

Pacritinib

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

Momelotinib

Participants will receive momelotinib per local package insert.

Primary outcome measure

  • Proportion of Participants with Spleen Volume Reduction ≥35% (SVR35) at Week 24 [ Time Frame: At Week 24 ]

Central Contacts and Locations

Central contacts

Karyopharm Medical Information

(888) 209-9326clinicaltrials@karyopharm.com

Locations

City of Hope - Duarte Main Site

Recruiting

Duarte, California, United States, 91010

Contacts

Haris Ali

6263564673harisali@coh.org

Principal Investigator:

Haris Ali

Maryland Oncology Hematology - Independent of SCRI/ US Oncology

Recruiting

Columbia, Maryland, United States, 21044

Contacts

Mohit Narang

304-942-9220mohit.narang@usoncology.com

Principal Investigator:

Mohit Narang

Weill Cornell Medicine NewYork-Presbyterian

Recruiting

New York, New York, United States, 10021

Contacts

Ellen Ritche

646-962-4580ritchie@med.cornell.edu

Principal Investigator:

Ellen Ritche

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Lindsay Rein

919-684-8964lindsay.magura@duke.edu

Principal Investigator:

Lindsay Rein

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Aaron Gerds

216-445-9840gerdsa@ccf.org

Principal Investigator:

Aaron Gerds

MD Anderson

Recruiting

Houston, Texas, United States, 77030

Contacts

Prithviraj Bose

(713) 792-7747PBose@mdanderson.org

Principal Investigator:

Prithviraj Bose

Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Srinivas Tantravahi

801-213-6170Srinivas.Tantravahi@hci.utah.edu

Principal Investigator:

Srinivas Tantravahi

Research Institute of the McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Jonathan How

jonathan.b.how@mcgill.ca

Principal Investigator:

Jonathan How

More Information

Sponsor

Karyopharm Therapeutics Inc

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Keywords

  • Myelofibrosis
  • Selinexor
  • Total Symptom Score
  • Myelofibrosis Symptom Assessment Form
  • Spleen Volume Reduction
  • TSS50
  • SVR35
  • JAK2
  • KPT-330
  • Pacritinib
  • Ruxolitinib
  • Momelotinib
  • Thrombocytopenia
  • Abs-TSS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Karyopharm Therapeutics Inc on 2026-02-12.