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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 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).
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.
  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05980806
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Karyopharm Therapeutics Inc
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Myelofibrosis, Moderate Thrombocytopenia
Arms & Interventions

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, death, or withdrawal of consent, whichever comes first and followed by optional add-on medication dosing may be initiated based on Spleen Volume Reduction (SVR) values.

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, death, or withdrawal of consent, whichever comes first and followed by optional add-on medication dosing may be initiated based on SVR values.

Experimental: Selinexor 60 mg (Optional Expansion Arm)

Participants will receive selinexor 60 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, death, or withdrawal of consent, whichever comes first. Optional add-on medication (ruxolitinib [5 mg or 10 mg twice daily], pacritinib [200 mg twice daily], or momelotinib [200 mg once daily]) may be initiated for participants whose SVR is less than (<) 10% at Week 12 or <35% at Week 24 based on the participants platelet count values (i.e., ruxolitinib if platelets greater than or equal to [>=] 50 x 10^9/L, pacritinib if platelets <50 x 10^9/L, momelotinib if platelets is >=50 x 10^9/L and hemoglobin level is < 10 gram per deciliter [g/dL]).

Experimental: Selinexor 40 mg (Optional Expansion Arm)

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, death, or withdrawal of consent, whichever comes first. Optional add-on medication (ruxolitinib [5 mg or 10 mg twice daily], pacritinib [200 mg twice daily], or momelotinib [200 mg once daily]) may be initiated for participants whose SVR is <10% at Week 12 or <35% at Week 24 based on the participants platelet count values (i.e., ruxolitinib if platelets >= 50 x 10^9/L, pacritinib if platelets <50 x 10^9/L, momelotinib if platelets is >=50 x 10^9/L and hemoglobin level is < 10 g/dL).

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 5 mg or 10 mg twice daily.

Drug: - Pacritinib

Participants will receive pacritinib 200 mg twice daily.

Drug: - Momelotinib

Participants will receive momelotinib 200 mg once daily.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

City of Hope - Duarte Main Site, Duarte, California

Status

Recruiting

Address

City of Hope - Duarte Main Site

Duarte, California, 91010

Site Contact

Haris Ali

[email protected]

626-356-4673

Columbia, Maryland

Status

Recruiting

Address

Maryland Oncology Hematology - Independent of SCRI/ US Oncology

Columbia, Maryland, 21044

Site Contact

Mohit Narang

[email protected]

304-942-9220

Cleveland Clinic, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Site Contact

Aaron Gerds

[email protected]

216-445-9840

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