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Clinical Trials in the UK / NCT05980806
Recruiting Phase 2

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

NCT05980806 · tracked via the Priya Life Science UK tracker
Sponsor
Karyopharm Therapeutics Inc
Phase
Phase 2
Started
2024-04-22
Last updated
2026-02-12

Condition(s) studied

MyelofibrosisModerate ThrombocytopeniaMild Thrombocytopenia

Investigational drug(s) / intervention(s)

Selinexor 60 mgSelinexor 40 mgRuxolitinibPacritinibMomelotinib

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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (70)

FacilityCityRegionStatus
City of Hope - Duarte Main Site Duarte California Recruiting
Maryland Oncology Hematology - Independent of SCRI/ US Oncology Columbia Maryland Recruiting
Weill Cornell Medicine NewYork-Presbyterian New York New York Recruiting
Duke University Durham North Carolina Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
MD Anderson Houston Texas Recruiting
Huntsman Cancer Institute Salt Lake City Utah Recruiting
UZ Gent Ghent Belgium Recruiting
UZ Leuven - Campus Gasthuisberg Leuven Belgium Recruiting
University Multiprofile Hospital for Active Treatment Sveti George - Base 1 Plovdiv Bulgaria Recruiting
University Hospital Sv.Ivan Rilski - Sofia Sofia Bulgaria Recruiting
University Multiprofile Hospital for Active Treatment Aleksandrovska Sofia Bulgaria Recruiting
Specialized Hospital for Active Treatment of Hematological Diseases - EAD Sofia Sofia Bulgaria Recruiting
University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD Department of Clinical Hematology Stara Zagora Bulgaria Recruiting
Research Institute of the McGill University Health Centre Montreal Quebec Recruiting
Fakultní nemocnice Olomouc Olomouc Czechia Recruiting
Aarhus Universitetshospital Aarhus N Central Jutland Recruiting
Institut Bergonié Bordeaux Aquitaine Recruiting
Centre Hospitalier Lyon-Sud Pierre-Bénite Auvergne-Rhône-Alpes Recruiting
CHU Tours, Hôpital Bretonneau Service d'Hématologie thérapie cellulaire Tours Indre-et-Loire Recruiting
Chu De Nîmes - Institut De Cancérologie Du Gard Nîmes Occitanie Recruiting
Centre Hospitalier Universitaire d'Angers Angers Pays de la Loire Region Recruiting
Hôpital Saint-Louis Paris France Recruiting
Hôpital Cochin Paris France Recruiting
Centre Hospitalier Universitaire de Saint-Etienne Saint-Priest-en-Jarez France Recruiting
Marien Hospital Düsseldorf Düsseldorf Germany Recruiting
University Hospital Jena Jena Germany Recruiting
Laiko General Hospital of Athens Athens Attica Recruiting
University General Hospital Attikon Athens Attica Recruiting
"Georgios Papanikolaou" General Hospital of Thessaloniki Thessaloniki Central Macedonia Recruiting
University General Hospital of Ioannina, Hematology Department Ioannina Epirus Recruiting
University General Hospital of Larissa, Hematology Department Larissa Thessaly Recruiting
Semmelweis Egyetem Budapest Hungary Recruiting
Tel Aviv Sourasky Medical Center Tel Aviv Tel Aviv Recruiting
Rambam Health Care Campus Haifa Israel Recruiting
Carmel Medical Center Haifa Israel Recruiting
Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico Milan Milan Recruiting
Hematology Division, Mauriziano Hospital, University of Turin Orbassano Torino Recruiting
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino Torino Turin Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Italy Recruiting

+ 30 more sites — see the full list on the official registry below.

On this site

📄 Jakafi (ruxolitinib) drug profile →

More Karyopharm Therapeutics Inc trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05980806 on ClinicalTrials.gov ↗ ← All trials in the UK