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RECRUITING

NCT05980806

PHASE2

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

Sponsor: Karyopharm Therapeutics Inc

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-04-22

Completion Date

2028-10

Last Updated

2026-02-12

Healthy Volunteers

Conditions

Myelofibrosis Moderate Thrombocytopenia Mild Thrombocytopenia

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 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.

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

Locations (70)

City of Hope - Duarte Main Site

Duarte, California, United States

Maryland Oncology Hematology - Independent of SCRI/ US Oncology

Columbia, Maryland, United States

Weill Cornell Medicine NewYork-Presbyterian

New York, New York, United States

Duke University

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

MD Anderson

Houston, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

UZ Gent

Ghent, Belgium

UZ Leuven - Campus Gasthuisberg

Leuven, Belgium

University Multiprofile Hospital for Active Treatment Sveti George - Base 1

Plovdiv, Bulgaria

University Hospital Sv.Ivan Rilski - Sofia

Sofia, Bulgaria

University Multiprofile Hospital for Active Treatment Aleksandrovska

Sofia, Bulgaria

Specialized Hospital for Active Treatment of Hematological Diseases - EAD Sofia

Sofia, Bulgaria

University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD Department of Clinical Hematology

Stara Zagora, Bulgaria

Research Institute of the McGill University Health Centre

Montreal, Quebec, Canada

Fakultní nemocnice Olomouc

Olomouc, Czechia

Aarhus Universitetshospital

Aarhus N, Central Jutland, Denmark

Institut Bergonié

Bordeaux, Aquitaine, France

Centre Hospitalier Lyon-Sud

Pierre-Bénite, Auvergne-Rhône-Alpes, France

CHU Tours, Hôpital Bretonneau Service d'Hématologie thérapie cellulaire

Tours, Indre-et-Loire, France

Chu De Nîmes - Institut De Cancérologie Du Gard

Nîmes, Occitanie, France

Centre Hospitalier Universitaire d'Angers

Angers, Pays de la Loire Region, France

Hôpital Saint-Louis

Paris, France

Hôpital Cochin

Paris, France

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Priest-en-Jarez, France

Marien Hospital Düsseldorf

Düsseldorf, Germany

University Hospital Jena

Jena, Germany

Laiko General Hospital of Athens

Athens, Attica, Greece

University General Hospital Attikon

Athens, Attica, Greece

"Georgios Papanikolaou" General Hospital of Thessaloniki

Thessaloniki, Central Macedonia, Greece

University General Hospital of Ioannina, Hematology Department

Ioannina, Epirus, Greece

University General Hospital of Larissa, Hematology Department

Larissa, Thessaly, Greece

Semmelweis Egyetem

Budapest, Hungary

Tel Aviv Sourasky Medical Center

Tel Aviv, Tel Aviv, Israel

Rambam Health Care Campus

Haifa, Israel

Carmel Medical Center

Haifa, Israel

Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico

Milan, Milan, Italy

Hematology Division, Mauriziano Hospital, University of Turin

Orbassano, Torino, Italy

Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino

Torino, Turin, Italy

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy

IRCCS Ospedale Policlinico San Martino

Genova, Italy

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST

Meldola, Italy

Istituto Europeo di Oncologia

Milan, Italy

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, Italy

Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

Novara, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Università Campus Bio-Medico di Roma

Rome, Italy

Spaarne Gasthuis

Hoofddorp, Netherlands

Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

Lublin, Poland

AIDPORT

Skórzewo, Poland

Medicover Clinical Integrated Systems Sp. z o.o.

Torun, Poland

Coltea - Spital Clinic

Bucharest, Romania

Spitalul Filantropia - Craiova

Craiova, Romania

Institutul Regional de Oncologie Iasi

Iași, Romania

Seoul St. Mary's Hospital, The Catholic University of Korea

Seocho, Seoul, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Severance Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Pusan National University Hospital

Busan, South Korea

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Hospital San Pedro de Alcantara

Cáceres, Spain

Institut Català d'Oncologia Girona

Girona, Spain

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, Spain

Complejo Asistencial Universitario de Salamanca - Hospital Clínico

Salamanca, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taoyuan Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Guy's and Saint Thomas' NHS Foundation Trust

London, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (70)