A Study of Selinexor Monotherapy in Subjects with JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia
NCT ID: NCT05980806
Last Updated: 2025-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
118 participants
INTERVENTIONAL
2024-04-22
2028-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Selinexor 60 mg
Participants will receive selinexor 60 mg oral tablets QW.
Ruxolitinib
Participants will receive ruxolitinib 5 mg or 10 mg twice daily.
Pacritinib
Participants will receive pacritinib 200 mg twice daily.
Momelotinib
Participants will receive momelotinib 200 mg once daily.
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.
Selinexor 40 mg
Participants will receive selinexor 40 mg oral tablets QW.
Ruxolitinib
Participants will receive ruxolitinib 5 mg or 10 mg twice daily.
Pacritinib
Participants will receive pacritinib 200 mg twice daily.
Momelotinib
Participants will receive momelotinib 200 mg once daily.
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 \[g/dL\]).
Selinexor 60 mg
Participants will receive selinexor 60 mg oral tablets QW.
Ruxolitinib
Participants will receive ruxolitinib 5 mg or 10 mg twice daily.
Pacritinib
Participants will receive pacritinib 200 mg twice daily.
Momelotinib
Participants will receive momelotinib 200 mg once daily.
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).
Selinexor 40 mg
Participants will receive selinexor 40 mg oral tablets QW.
Ruxolitinib
Participants will receive ruxolitinib 5 mg or 10 mg twice daily.
Pacritinib
Participants will receive pacritinib 200 mg twice daily.
Momelotinib
Participants will receive momelotinib 200 mg once daily.
Interventions
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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 5 mg or 10 mg twice daily.
Pacritinib
Participants will receive pacritinib 200 mg twice daily.
Momelotinib
Participants will receive momelotinib 200 mg once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Karyopharm Therapeutics Inc
INDUSTRY
Responsible Party
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Locations
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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
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
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
Semmelweis Egyetem
Budapest, , Hungary
Hematology Division, Mauriziano Hospital, University of Turin
Orbassano, Torino, 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
Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico
Milan, , Italy
Istituto Europeo di Oncologia
Milan, , 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
Seoul St. Mary's Hospital, The Catholic University of Korea
Seocho-gu, Seoul, South Korea
Severance Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Pusan National University Hospital
Busan, , South Korea
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
Countries
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Central Contacts
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Facility Contacts
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Haris Ali
Role: backup
Mohit Narang
Role: backup
Ellen Ritche
Role: backup
Lindsay Rein
Role: backup
Aaron Gerds
Role: backup
Srinivas Tantravahi
Role: backup
Dominiek Mazure
Role: backup
Timothy Devos
Role: backup
Zhanet Grudeva-Popova
Role: backup
Atanas Radinoff
Role: backup
Evgueniy Hadjiev
Role: backup
Martin Donchev
Role: backup
Mariya Todorova
Role: backup
Jonathan How
Role: backup
Fiorenza Barraco
Role: backup
Antoine Machet
Role: backup
Stefan Wickenhauser
Role: backup
Françoise Boyer-Perrard
Role: backup
Jean-Jacques Kiladjian
Role: backup
Lise Willems
Role: backup
Philippe Renaudier
Role: backup
Role: primary
Stefanie Groepper
Role: backup
Carl Crodel
Role: backup
Zsolt Nagy
Role: backup
Daniela Cilloni
Role: backup
Francesca Palandri
Role: backup
Roberto Lemoli
Role: backup
Alessandro Lucchesi
Role: backup
Alessandra Lurlo
Role: backup
Federica Gigli
Role: backup
Elisa Rumi
Role: backup
Luigi Rigacci
Role: backup
Aart Beeker
Role: backup
Krzysztof Giannopoulos
Role: backup
Michał Kwiatek
Role: backup
Dominik Charaniuk
Role: backup
Gabriela Borsaru
Role: backup
Luminita Ocroteala
Role: backup
Sung-Eun Lee
Role: backup
June-Won Cheong
Role: backup
HoJin Shin
Role: backup
Role: primary
Raúl Perez López
Role: backup
Maria Angeles Fernandez Rodriguez
Role: backup
Victor Higuero Saavedra
Role: backup
Role: primary
Anna Angona
Role: backup
Adrián Segura Diaz
Role: backup
Jesús Maria Hernández Rivas
Role: backup
Irene Pastor Galan
Role: backup
Other Identifiers
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XPORT-MF-044
Identifier Type: -
Identifier Source: org_study_id
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