Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
NCT ID: NCT04562389
Last Updated: 2025-10-03
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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ACTIVE_NOT_RECRUITING
PHASE3
353 participants
INTERVENTIONAL
2021-03-11
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Phase 1a: Cohort 1: Selinexor 40 mg + Ruxolitinib BID
Participants with MF will receive a dose of 40 milligrams (mg) selinexor oral tablets once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with 15 or 20 mg ruxolitinib twice a day (BID) based on the participants baseline platelet count.
Selinexor
Participants will receive a dose of 40 or 60 mg selinexor oral tablets QW.
Ruxolitinib
Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID.
Phase 1a: Cohort 2: Selinexor 60 mg + Ruxolitinib BID
Participants with MF will receive a dose of 60 mg selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.
Selinexor
Participants will receive a dose of 40 or 60 mg selinexor oral tablets QW.
Ruxolitinib
Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID.
Phase 1b: Selinexor and Ruxolitinib BID
Participants with MF will receive a dose of 40 or 60 mg selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.
Selinexor
Participants will receive a dose of 40 or 60 mg selinexor oral tablets QW.
Ruxolitinib
Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID.
Phase 3: Selinexor 60 mg + Ruxolitinib BID
Participants with MF will receive a fixed starting dose of 60 mg selinexor (RD) oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with a starting dose of 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.
Selinexor
Participants will receive a dose of 60 mg selinexor oral tablets QW.
Ruxolitinib
Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID.
Phase 3: Placebo + Ruxolitinib BID
Participants with MF will receive a matching placebo of selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with a starting dose of 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.
Placebo
Participants will receive a matching placebo of selinexor oral tablets QW
Ruxolitinib
Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID.
Interventions
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Selinexor
Participants will receive a dose of 40 or 60 mg selinexor oral tablets QW.
Selinexor
Participants will receive a dose of 60 mg selinexor oral tablets QW.
Placebo
Participants will receive a matching placebo of selinexor oral tablets QW
Ruxolitinib
Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A diagnosis of primary MF or post-essential thrombocythemia (ET) or postpolycythemia- vera (PV) MF.
* Active symptoms of MF as determined by presence of at least 2 symptoms using the Myelofibrosis Symptom Assessment Form (MFSAF) V4.0.
* Participants with international prognostic scoring system (DIPSS) risk category of intermediate-1, or intermediate-2, or high-risk.
* Measurable splenomegaly during the screening period as demonstrated by spleen volume of greater than or equal to (\>=) 450 cubic centimeter (cm\^3) .
* Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (\<=) 2.
Exclusion Criteria
* Previous treatment with JAK inhibitors for MF.
* Previous treatment with selinexor or other XPO1 inhibitors.
18 Years
ALL
No
Sponsors
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Karyopharm Therapeutics Inc
INDUSTRY
Responsible Party
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Locations
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UAB Division of Hematology/Oncology
Birmingham, Alabama, United States
UCLA - Satellite Site
Beverly Hills, California, United States
City of Hope
Duarte, California, United States
UCLA - Satellite Site
Encino, California, United States
City of Hope - Irvine Lennar - Satellite
Irvine, California, United States
UCLA
Los Angles, California, United States
The Oncology Institute of Hope & Innovation
Pasadena, California, United States
USOR - Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States
Smilow Cancer Hospital - New Haven
New Haven, Connecticut, United States
Georgetown Lombardi Comprehensive Center
Washington D.C., District of Columbia, United States
Norton Cancer Institute - Saint Matthews
Louisville, Kentucky, United States
Maryland Oncology Hematology-Satellite
Annapolis, Maryland, United States
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Maryland Oncology Hematology-Satellite
Brandywine, Maryland, United States
Maryland Oncology Hematology
Columbia, Maryland, United States
Maryland Oncology Hematology-Satellite
Rockville, Maryland, United States
Maryland Oncology Hematology-Satellite
Silver Spring, Maryland, United States
The Cancer & Hematology Centers -Satellite Site
Grand Rapids, Michigan, United States
The Cancer & Hematology Centers of Muskegon
Norton Shores, Michigan, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Mount Sinai Health System
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke Cancer Institue
Durham, North Carolina, United States
USOR - Oncology Hematology Care - Kenwood
Cincinnati, Ohio, United States
Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States
OhioHealth
Columbus, Ohio, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States
Texas Oncology
Dallas, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
USOR - Virginia Cancer Specialists - Gainesville Office
Gainesville, Virginia, United States
VCU Massey Cancer Center
Richmond, Virginia, United States
USOR - Virginia Oncology Associates - Virginia Beach
Virginia Beach, Virginia, United States
Fred Hutchinson Cancer Center - SCAA South Lake Union
Seattle, Washington, United States
West Virginia University Cancer Institute, Wheeling Hospital
Wheeling, West Virginia, United States
University of Wisconsin - Madison
Madison, Wisconsin, United States
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, Australia
Campbelltown Hospital
Campbelltown, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Icon Cancer Centre - Wesley
South Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
One Clinical Research
Nedlands, Western Australia, Australia
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Flemish Brabant, Belgium
Universitair Ziekenhuis Gent
Ghent, Oost-Vlaanderen, Belgium
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
Bruges, West-Vlaanderen, Belgium
ZNA Stuivenberg - Satelite
Antwerp, , Belgium
ZNA Stuivenberg
Antwerp, , Belgium
University Multiprofile Hospital for Active Treatment Sveti George - Base 1
Plovdiv, , Bulgaria
University Multiprofile Hospital for Active Treatment Aleksandrovska
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment St. Ivan Rilski
Sofia, , Bulgaria
Specialized Hospital for Active Treatment of Hematological Diseases - EAD Sofia
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich
Stara Zagora, , Bulgaria
University of Alberta Hospital
Edmonton, Alberta, Canada
Lakeridge Health
Oshawa, Ontario, Canada
Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada
Vseobecna Fakultni Nemocnice v Praze
Prague, Prague, Czechia
Fakultní Nemocnice Hradec Králové
Hradec Králové, , Czechia
Fakultní Nemocnice Olomouc
Olomouc, , Czechia
Aarhus Universitetshospital
Aarhus N, Central Jutland, Denmark
Tang Severinsen, Marianne
Aalborg, North Denmark, Denmark
Institut Bergonié
Bordeaux, Aquitaine, France
Centre Hospitalier Universitaire Estaing
Clermont-Ferrand, Aubergne, France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, France
Hôpital Morvan
Brest, Brittany Region, France
Chu De Nîmes - Institut De Cancérologie Du Gard
Nîmes, Gard, France
Hôpital Emile Muller
Mulhouse, Grand Est, France
Hôpital Huriez
Lille, Hauts-de-France, France
Hôpital Bretonneau
Tours, Indre-et-Loire, France
Hôpital l'Archet - CHU Nice
Nice, PACA, France
Centre Hospitalier Universitaire d'Angers
Angers, Pays de la Loire Region, France
Centre Hospitalier Universitaire de Saint-Étienne
Saint-Priest-en-Jarez, Pays de la Loire Region, France
Hôpital Saint-Louis
Paris, , France
Hôpital Universitaire Pitié Salpêtrière
Paris, Île-de-France Region, France
Hôpital Cochin
Paris, Île-de-France Region, France
Kliniken Ostalb - Stauferklinikum Schwäbisch Gmünd
Mutlangen, Baden-Wurttemberg, Germany
Marien Hospital Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany
Universitätsklinikum Halle
Halle, Saxony-Anhalt, Germany
Städtisches Krankenhaus Kiel
Kiel, Schleswig-Holstein, Germany
Universitätsklinikum Jena
Jena, Thuringia, Germany
Laiko General Hospital of Athens
Athens, Attica, Greece
General Hospital of Athens "Alexandra"
Athens, Attica, Greece
University General Hospital Attikon
Athens, Attica, Greece
General Hospital of Thessaloniki George Papanikolaou
Thessaloniki, Central Macedonia, Greece
University General Hospital of Ioannina
Ioánnina, Thessaly, Greece
University General Hospital of Larissa, Hematology Department
Larissa, Thessaly, Greece
Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház
Győr, Győr-Moson-Sopron, Hungary
Semmelweis Egyetem
Budapest, , Hungary
Shamir Medical Center (Assaf Harofeh)
Be’er Ya‘aqov, Central District, Israel
The Chaim Sheba Medical Center
Ramat Gan, Central District, Israel
Rambam Health Care Campus
Haifa, Haifa District, Israel
Carmel Medical Center
Haifa, Haifa District, Israel
Hadassah University Hospital - Mount Scopus - Satellite Site
Jerusalem, Jerusalem, Israel
Hadassah University Hospital Ein Kerem
Jerusalem, Jerusalem, Israel
Emek Medical Center
Afula, Northern District, Israel
Western Galilee Hospital-Nahariya
Nahariya, Northern District, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco - Catania/ Presidio G. Rodolico
Catania, Catania, Italy
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
Meldola, Forli-Cesena, Italy
IRCCS Ospedale Policlinico San Martino
Genova, Genoa, Italy
Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico
Milan, Milan, Italy
Istituto Europeo di Oncologia
Milan, Milan, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, Milan, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, Monza and Brianza, Italy
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
Novara, Novara, Italy
IRCCS Centro di Riferimento Oncologico di Basilicata
Rionero in Vulture, Potenza, Italy
Umberto I - Policlinico di Roma
Roma, Rome, Italy
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
Torino, Turin, Italy
Università Campus Bio-Medico di Roma
Rome, Viterbo, Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi
Bologna, , Italy
Azienda Ospedaliero - Universitaria Careggi
Florence, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, , Italy
Centro Ricerche Cliniche di Verona
Verona, , Italy
Spaarne Gasthuis - Hoofddorp
Hoofddorp, North Holland, Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
AIDPORT
Skórzewo, Greater Poland Voivodeship, Poland
Medicover Integrated Clinical Services (MICS) - Centrum Medyczne Toruń
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku
Wroclaw, Lower Silesian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
Lublin, Lublin Voivodeship, Poland
Szpital Specjalistyczny w Brzozowie - Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza
Brzozów, Podkarpackie Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne w Gdańsku
Gdansk, Pomeranian Voivodeship, Poland
Pratia Onkologia Katowice
Katowice, Silesian Voivodeship, Poland
Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu
Wałbrzych, Silesian Voivodeship, Poland
Institutul Oncologic Prof. Dr. Ion Chiricuta
Cluj-Napoca, Cluj, Romania
Spitalul Filantropia - Craiova
Craiova, Dolj, Romania
Spitalul Clinic Judetean De Urgenta Târgu Mureș
Târgu Mureş, Mureș County, Romania
Coltea - Spital Clinic
Bucharest, , Romania
Spitalul Clinic Colentina
Bucharest, , Romania
Institutul Regional De Oncologie Iasi
Iași, , Romania
Pusan National University Hospital
Busan, Gwang'yeogsi, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
The Catholic University of Korea - Seoul St. Mary's Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital San Pedro de Alcantara
Cáceres, Cáceres, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital de Día Quirónsalud Zaragoza
Zaragoza, Zaragoza, Spain
Institut Català d'Oncologia Badalona
Badalona, , Spain
Hospital Universitari Vall d'Hebrón
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Institut Català d'Oncologia Girona (ICO Girona)
Girona, , Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, , Spain
Hospital Universitario Lucus Augusti
Lugo, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, , Spain
Complejo Asistencial Universitario de Salamanca - Hospital Clínico
Salamanca, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
China Medical University Hospital
Taichung, Taichung, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital - Linkou Branch
Taoyuan District, , Taiwan
Guy's and St Thomas' NHS Foundation Trust
London, England, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, England, United Kingdom
United Lincolnshire Hospitals NHS Trust-Satellite Site
Boston, , United Kingdom
United Lincolnshire Hospitals NHS Trust
Boston, , United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Mascarenhas J, Maher K, Rampal R, Bose P, Podoltsev N, Hong J, Chai Y, Kye S, Method M, Harrison C; SENTRY investigators. Selinexor plus ruxolitinib in JAK inhibitor treatment-naive myelofibrosis: SENTRY Phase 3 study design. Future Oncol. 2025 Mar;21(7):807-813. doi: 10.1080/14796694.2025.2461393. Epub 2025 Feb 6.
Other Identifiers
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2020-003883-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-506139-13-00
Identifier Type: CTIS
Identifier Source: secondary_id
XPORT-MF-034
Identifier Type: -
Identifier Source: org_study_id
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