RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main purpose of this study with corresponding optional expansion is to evaluate the efficacy of selinexor in JAKi-naïve participants with myelofibrosis (MF) and moderate thrombocytopenia based on spleen volume reduction (SVR). Additional efficacy and safety parameters will also be assessed during the study.

Official Title

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

Quick Facts

Study Start:2024-04-22

Study Completion:2028-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05980806

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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 screening are acceptable). * Participants with 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 50 to less than (\<) 100 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 aminotransferase (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 a score \>= 3 or total score of \>= 10 at screening using the MFSAF V4.0. * Participants must provide bone marrow biopsy samples (samples obtained up to 3 months prior to C1D1 are permitted) at screening and during the study. * Participants currently not a candidate for stem cell transplantation. * Participants must be willing to complete the MFSAF V4.0 daily during the study for evaluating the symptom response (i.e., TSS50).	* 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. * Female participants who are pregnant or lactating. * Prior splenectomy, or splenic radiation within 6 months prior to C1D1. * History of myocardial infarction, unstable angina, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG), cerebrovascular accident (stroke or transient ischemic attack \[TIA\]), ventricular arrhythmias, congestive heart failure New York Heart Association (NYHA) class \> 2 within 6 months of C1D1. * Participants unable to tolerate two forms of antiemetics prior to each dose for the first two cycles.

Inclusion Criteria

Exclusion 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 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 screening are acceptable).
* Participants with 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 50 to less than (\<) 100 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 aminotransferase (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 a score \>= 3 or total score of \>= 10 at screening using the MFSAF V4.0.
* Participants must provide bone marrow biopsy samples (samples obtained up to 3 months prior to C1D1 are permitted) at screening and during the study.
* Participants currently not a candidate for stem cell transplantation.
* Participants must be willing to complete the MFSAF V4.0 daily during the study for evaluating the symptom response (i.e., TSS50).

* 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.
* Female participants who are pregnant or lactating.
* Prior splenectomy, or splenic radiation within 6 months prior to C1D1.
* History of myocardial infarction, unstable angina, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG), cerebrovascular accident (stroke or transient ischemic attack \[TIA\]), ventricular arrhythmias, congestive heart failure New York Heart Association (NYHA) class \> 2 within 6 months of C1D1.
* Participants unable to tolerate two forms of antiemetics prior to each dose for the first two cycles.

Contacts and Locations

Study Contact

Karyopharm Medical Information

CONTACT

(888) 209-9326

clinicaltrials@karyopharm.com

Study Locations (Sites)

City of Hope - Duarte Main Site

Duarte, California, 91010

United States

Maryland Oncology Hematology - Independent of SCRI/ US Oncology

Columbia, Maryland, 21044

United States

Weill Cornell Medicine NewYork-Presbyterian

New York, New York, 10021

United States

Duke University

Durham, North Carolina, 27705

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

United States

Collaborators and Investigators

Sponsor: Karyopharm Therapeutics Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-22

Study Completion Date2028-10

Study Record Updates

Study Start Date2024-04-22

Study Completion Date2028-10

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Myelofibrosis
Moderate Thrombocytopenia