Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis (SENTRY)

April 7, 2026 updated by: Karyopharm Therapeutics Inc

A Phase 1/3 Study to Evaluate Efficacy and Safety of Selinexor, a Selective Inhibitor of Nuclear Export, in Combination With Ruxolitinib in Treatment-naïve Patients With Myelofibrosis

This is a global, multicenter, 2-part study to evaluate the efficacy and safety of selinexor plus ruxolitinib in JAK inhibitor (JAKi) treatment-naïve myelofibrosis (MF) participants. The study will be conducted in two phases: Phase 1 (open-label) and Phase 3 (double-blind). Phase 1 (enrollment completed) was an open-label evaluation of the safety and recommended Phase 2 dose (RP2D) of selinexor in combination with ruxolitinib and included a dose escalation using a standard 3+3 design (Phase 1a) and a dose expansion part (Phase 1b). Phase 3 (ongoing), double-blind, placebo-controlled part of the study comparing the efficacy and safety of combination therapy of selinexor + ruxolitinib with combination of placebo + ruxolitinib.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

353

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Bankstown, New South Wales, Australia, 2200
        • Bankstown-Lidcombe Hospital
      • Campbelltown, New South Wales, Australia, 2560
        • Campbelltown Hospital
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Icon Cancer Centre - Wesley
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • One Clinical Research
  • Belgium
      • Antwerp, Belgium, 2060
        • ZNA Stuivenberg
      • Antwerp, Belgium, 2030
        • ZNA Stuivenberg - Satelite
    • Flemish Brabant
      • Leuven, Flemish Brabant, Belgium, 3000
        • Universitair Ziekenhuis Leuven - Campus Gasthuisberg
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Universitair Ziekenhuis Gent
    • West-Vlaanderen
      • Bruges, West-Vlaanderen, Belgium, 8000
        • Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • University Multiprofile Hospital for Active Treatment Sveti George - Base 1
      • Sofia, Bulgaria, 1431
        • University Multiprofile Hospital for Active Treatment Aleksandrovska
      • Sofia, Bulgaria, 1431
        • University Multiprofile Hospital for Active Treatment St. Ivan Rilski
      • Sofia, Bulgaria, 1797
        • Specialized Hospital for Active Treatment of Hematological Diseases - EAD Sofia
      • Stara Zagora, Bulgaria, 6003
        • University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2G3
        • University of Alberta Hospital
    • Ontario
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Research Institute of the McGill University Health Centre
  • Czechia
      • Hradec Králové, Czechia, 500 05
        • Fakultni Nemocnice Hradec Kralove
      • Olomouc, Czechia, 779 00
        • Fakultni Nemocnice Olomouc
    • Prague
      • Prague, Prague, Czechia, 128 08
        • Vseobecna Fakultni Nemocnice V Praze
  • Denmark
    • Central Jutland
      • Aarhus N, Central Jutland, Denmark, 8200
        • Aarhus Universitetshospital
    • North Denmark
      • Aalborg, North Denmark, Denmark, 9000
        • Tang Severinsen, Marianne
  • France
      • Paris, France, 75010
        • Hopital Saint-Louis
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33000
        • Institut Bergonié
    • Aubergne
      • Clermont-Ferrand, Aubergne, France, 63003
        • Centre Hospitalier Universitaire Estaing
    • Auvergne-Rhône-Alpes
      • Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69495
        • Centre Hospitalier Lyon-Sud
    • Brittany Region
      • Brest, Brittany Region, France, 29200
        • Hopital Morvan
    • Gard
      • Nîmes, Gard, France, 30029
        • CHU de NÎMES - Institut de Cancérologie du Gard
    • Grand Est
      • Mulhouse, Grand Est, France, 68100
        • Hôpital Emile Muller
    • Hauts-de-France
      • Lille, Hauts-de-France, France, 59037
        • Hôpital Huriez
    • Indre-et-Loire
      • Tours, Indre-et-Loire, France, 37044
        • Hopital Bretonneau
    • PACA
      • Nice, PACA, France, 06202
        • Hôpital l'Archet - CHU Nice
    • Pays de la Loire Region
      • Angers, Pays de la Loire Region, France, 49 933
        • Centre Hospitalier Universitaire d'Angers
      • Saint-Priest-en-Jarez, Pays de la Loire Region, France, 42271
        • Centre Hospitalier Universitaire de Saint-Étienne
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75014
        • Hopital Cochin
      • Paris, Île-de-France Region, France, 75013
        • Hôpital Universitaire Pitié Salpêtrière
  • Germany
    • Baden-Wurttemberg
      • Mutlangen, Baden-Wurttemberg, Germany, 73557
        • Kliniken Ostalb - Stauferklinikum Schwäbisch Gmünd
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Germany, 40479
        • Marien Hospital Düsseldorf
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 6120
        • Universitatsklinikum Halle
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24116
        • Stadtisches Krankenhaus Kiel
    • Thuringia
      • Jena, Thuringia, Germany, 7747
        • Universitätsklinikum Jena
  • Greece
    • Attica
      • Athens, Attica, Greece, 124 62
        • University General Hospital Attikon
      • Athens, Attica, Greece, 115 27
        • Laiko General Hospital of Athens
      • Athens, Attica, Greece, 115 28
        • General Hospital of Athens "Alexandra"
    • Central Macedonia
      • Thessaloniki, Central Macedonia, Greece, 570 10
        • General Hospital of Thessaloniki George Papanikolaou
    • Thessaly
      • Ioánnina, Thessaly, Greece, 455 00
        • University General Hospital of Ioannina
      • Larissa, Thessaly, Greece, 41110
        • University General Hospital of Larissa, Hematology Department
  • Hungary
      • Budapest, Hungary, 1088
        • Semmelweis Egyetem
    • Győr-Moson-Sopron
      • Győr, Győr-Moson-Sopron, Hungary, 9023
        • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
  • Israel
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center
    • Central District
      • Be’er Ya‘aqov, Central District, Israel, 7030000
        • Shamir Medical Center (Assaf Harofeh)
      • Ramat Gan, Central District, Israel, 5265601
        • The Chaim Sheba Medical Center
    • Haifa District
      • Haifa, Haifa District, Israel, 3109601
        • Rambam Health Care Campus
      • Haifa, Haifa District, Israel, 3436212
        • Carmel Medical Center
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 9112001
        • Hadassah University Hospital - Mount Scopus - Satellite Site
      • Jerusalem, Jerusalem, Israel, 9112001
        • Hadassah University Hospital Ein Kerem
    • Northern District
      • Afula, Northern District, Israel, 1834111
        • Emek Medical Center
      • Nahariya, Northern District, Israel, 2210001
        • Western Galilee Hospital-Nahariya
  • Italy
      • Bologna, Italy, 40138
        • Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi
      • Florence, Italy, 50134
        • Azienda Ospedaliero - Universitaria Careggi
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
      • Torino, Italy, 10128
        • Azienda Ospedaliera Ordine Mauriziano di Torino
      • Verona, Italy, 37134
        • Centro Ricerche Cliniche Di Verona
    • Catania
      • Catania, Catania, Italy, 95123
        • Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco - Catania/ Presidio G. Rodolico
    • Forli-Cesena
      • Meldola, Forli-Cesena, Italy, 47014
        • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
    • Genoa
      • Genova, Genoa, Italy, 16132
        • IRCCS Ospedale Policlinico San Martino
    • Milan
      • Milan, Milan, Italy, 20122
        • Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico
      • Milan, Milan, Italy, 20141
        • Istituto Europeo Di Oncologia
      • Milan, Milan, Italy, 20162
        • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
    • Monza and Brianza
      • Monza, Monza and Brianza, Italy, 20900
        • Fondazione IRCCS San Gerardo dei Tintori
    • Novara
      • Novara, Novara, Italy, 28100
        • Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
    • Potenza
      • Rionero in Vulture, Potenza, Italy, 85028
        • IRCCS Centro di Riferimento Oncologico di Basilicata
    • Rome
      • Roma, Rome, Italy, 00161
        • Umberto I - Policlinico di Roma
    • Turin
      • Torino, Turin, Italy, 10126
        • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
    • Viterbo
      • Rome, Viterbo, Italy, 00128
        • Università Campus Bio-Medico di Roma
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Universitair Medisch Centrum Groningen
    • North Holland
      • Hoofddorp, North Holland, Netherlands, 2134 TM
        • Spaarne Gasthuis - Hoofddorp
  • Poland
    • Greater Poland Voivodeship
      • Skórzewo, Greater Poland Voivodeship, Poland, 60-185
        • Aidport
    • Kuyavian-Pomeranian Voivodeship
      • Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
        • Medicover Integrated Clinical Services (MICS) - Centrum Medyczne Toruń
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 53-439
        • Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-093
        • Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
    • Podkarpackie Voivodeship
      • Brzozów, Podkarpackie Voivodeship, Poland, 36-200
        • Szpital Specjalistyczny w Brzozowie - Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-952
        • Uniwersyteckie Centrum Kliniczne w Gdansku
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-519
        • Pratia Onkologia Katowice
      • Wałbrzych, Silesian Voivodeship, Poland, 58-309
        • Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu
  • Romania
      • Bucharest, Romania, 20125
        • Spitalul Clinic Colentina
      • Bucharest, Romania, 020125
        • Coltea - Spital Clinic
      • Iași, Romania, 700483
        • Institutul Regional de Oncologie Iasi
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Institutul Oncologic Prof. Dr. Ion Chiricuta
    • Dolj
      • Craiova, Dolj, Romania, 200136
        • Spitalul Filantropia - Craiova
    • Mureș County
      • Târgu Mureş, Mureș County, Romania, 540136
        • Spitalul Clinic Judetean de Urgenta Targu Mures
  • South Korea
      • Daegu, South Korea, 41944
        • Kyungpook National University Hospital
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 03722
        • Severance Hospital
      • Seoul, South Korea, 6351
        • Samsung Medical Center
      • Seoul, South Korea, 06591
        • The Catholic University of Korea - Seoul St. Mary's Hospital
    • Gwang'Yeogsi
      • Busan, Gwang'Yeogsi, South Korea, 49241
        • Pusan National University Hospital
    • Gyeonggido
      • Seongnam-si, Gyeonggido, South Korea, 13605
        • Seoul National University Bundang Hospital
    • Jeollanam-do
      • Hwasun, Jeollanam-do, South Korea, 58128
        • Chonnam National University Hwasun Hospital
  • Spain
      • Badalona, Spain, 08916
        • Institut Català d'Oncologia Badalona
      • Barcelona, Spain, 08036
        • Hospital Clinic De Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Girona, Spain, 17007
        • Institut Català d'Oncologia Girona (ICO Girona)
      • Las Palmas de Gran Canaria, Spain, 35010
        • Hospital Universitario de Gran Canaria Doctor Negrín
      • Lugo, Spain, 27003
        • Hospital Universitario Lucus Augusti
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • Murcia, Spain, 30120
        • Hospital Clínico Universitario Virgen de la Arrixaca
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Salamanca, Spain, 37007
        • Complejo Asistencial Universitario de Salamanca - Hospital Clínico
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
    • Cáceres
      • Cáceres, Cáceres, Spain, 10003
        • Hospital San Pedro de Alcantara
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias
    • Zaragoza
      • Zaragoza, Zaragoza, Spain, 50012
        • Hospital de Día Quirónsalud Zaragoza
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Chang Gung Memorial Hospital - Kaohsiung Branch
      • Kaohsiung City, Taiwan, 80756
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital
      • Taoyuan District, Taiwan, 33305
        • Chang Gung Memorial Hospital - Linkou Branch
    • Taichung
      • Taichung, Taichung, Taiwan, 40447
        • China Medical University Hospital
  • United Kingdom
      • Boston, United Kingdom, PE21 9QS
        • United Lincolnshire Hospitals NHS Trust
      • Boston, United Kingdom, PE21 9QS
        • United Lincolnshire Hospitals NHS Trust-Satellite Site
      • Liverpool, United Kingdom, LZ 8XP
        • The Clatterbridge Cancer Centre NHS Foundation Trust
      • London, United Kingdom, W12 0HS
        • Imperial College Healthcare NHS Trust
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • The Newcastle upon Tyne Hospitals NHS Foundation Trust
    • England
      • London, England, United Kingdom, SE1 9RT
        • Guy's and St Thomas' NHS Foundation Trust
      • Oxford, England, United Kingdom, OX3 7LE
        • Oxford University Hospitals NHS Foundation Trust
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • UAB Division of Hematology/Oncology
    • California
      • Beverly Hills, California, United States, 90210
        • UCLA - Satellite Site
      • Duarte, California, United States, 91010
        • City of Hope
      • Encino, California, United States, 93003
        • UCLA - Satellite Site
      • Irvine, California, United States, 92618
        • City of Hope - Irvine Lennar - Satellite
      • Los Angles, California, United States, 90095
        • UCLA
      • Pasadena, California, United States, 91105
        • The Oncology Institute of Hope & Innovation
    • Colorado
      • Aurora, Colorado, United States, 80045
        • USOR - Rocky Mountain Cancer Centers - Aurora
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Smilow Cancer Hospital - New Haven
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Georgetown Lombardi Comprehensive Center
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Norton Cancer Institute - Saint Matthews
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Maryland Oncology Hematology-Satellite
      • Baltimore, Maryland, United States, 21205
        • The Sidney Kimmel Comprehensive Cancer Center
      • Brandywine, Maryland, United States, 21004
        • Maryland Oncology Hematology-Satellite
      • Columbia, Maryland, United States, 21044
        • Maryland Oncology Hematology
      • Rockville, Maryland, United States, 20850
        • Maryland Oncology Hematology-Satellite
      • Silver Spring, Maryland, United States, 20904
        • Maryland Oncology Hematology-Satellite
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • The Cancer & Hematology Centers -Satellite Site
      • Norton Shores, Michigan, United States, 49444
        • The Cancer & Hematology Centers of Muskegon
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at Hackensack University Medical Center
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10029
        • Mount Sinai Health System
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke Cancer Institue
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • USOR - Oncology Hematology Care - Kenwood
      • Columbus, Ohio, United States, 43214
        • OhioHealth
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Ingram Cancer Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Texas Oncology
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute
    • Virginia
      • Gainesville, Virginia, United States, 20155
        • USOR - Virginia Cancer Specialists - Gainesville Office
      • Richmond, Virginia, United States, 23298
        • Vcu Massey Cancer Center
      • Virginia Beach, Virginia, United States, 23456
        • USOR - Virginia Oncology Associates - Virginia Beach
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Center - SCAA South Lake Union
    • West Virginia
      • Wheeling, West Virginia, United States, 26003
        • West Virginia University Cancer Institute, Wheeling Hospital
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin - Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged ≥ 18 years
  • 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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Selinexor
Participants will receive a dose of 40 or 60 mg selinexor oral tablets QW.
Other Names:
  • KPT-330
Drug: Selinexor
Participants will receive a dose of 60 mg selinexor oral tablets QW.
Other Names:
  • KPT-330
Drug: Ruxolitinib
Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID.
Experimental: 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.
Drug: Selinexor
Participants will receive a dose of 40 or 60 mg selinexor oral tablets QW.
Other Names:
  • KPT-330
Drug: Selinexor
Participants will receive a dose of 60 mg selinexor oral tablets QW.
Other Names:
  • KPT-330
Drug: Ruxolitinib
Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID.
Experimental: 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.
Drug: Selinexor
Participants will receive a dose of 40 or 60 mg selinexor oral tablets QW.
Other Names:
  • KPT-330
Drug: Selinexor
Participants will receive a dose of 60 mg selinexor oral tablets QW.
Other Names:
  • KPT-330
Drug: Ruxolitinib
Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID.
Experimental: 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.
Drug: Selinexor
Participants will receive a dose of 40 or 60 mg selinexor oral tablets QW.
Other Names:
  • KPT-330
Drug: Selinexor
Participants will receive a dose of 60 mg selinexor oral tablets QW.
Other Names:
  • KPT-330
Drug: Ruxolitinib
Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID.
Active Comparator: 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.
Drug: Ruxolitinib
Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID.
Other: Placebo
Participants will receive a matching placebo of selinexor oral tablets QW

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phase 1: Maximum Tolerated Dose (MTD)
Time Frame: Approximately within the first cycle (28 days) of therapy
Approximately within the first cycle (28 days) of therapy
Phase 1: Recommended Phase 2 Dose (RP2D)
Time Frame: Approximately within the first cycle (28 days) of therapy
Approximately within the first cycle (28 days) of therapy
Phase 1: Number of Participants With Adverse Events (AEs) by Occurrence, Nature, and Severity
Time Frame: From start of drug administration up to 30 days after last dose of study treatment (approximately 48 months)
From start of drug administration up to 30 days after last dose of study treatment (approximately 48 months)
Phase 3: Proportion of Participants with Spleen Volume Reduction (SVR) of Greater than or Equal to (>=) 35 Percent (%) (SVR35) at Week 24 Measured by the Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) Scan
Time Frame: At Week 24
At Week 24
Phase 3: Absolute mean change in TSS (Abs-TSS) from baseline to Week 24 as measured by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0
Time Frame: At Week 24
At Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Phase 3: Progression-free survival (PFS)
Time Frame: Time from randomization until disease progression or death, whichever occurs first (approximately 48 months)
Time from randomization until disease progression or death, whichever occurs first (approximately 48 months)
Phase 3: Overall survival (OS)
Time Frame: From Baseline up to EoS (approximately 48 months)
From Baseline up to EoS (approximately 48 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karyopharm Therapeutics Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2021

Primary Completion (Actual)

February 20, 2026

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

September 14, 2020

First Submitted That Met QC Criteria

September 18, 2020

First Posted (Actual)

September 24, 2020

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XPORT-MF-034
  • 2020-003883-19 (EudraCT Number)
  • 2023-506139-13-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myelofibrosis

Clinical Trials on Selinexor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe