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ACTIVE NOT RECRUITING
NCT04562389
PHASE3

Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis

Sponsor: Karyopharm Therapeutics Inc

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

353

Start Date

2021-03-11

Completion Date

2028-03

Last Updated

2026-04-09

Healthy Volunteers

No

Conditions

Interventions

DRUG

Selinexor

Participants will receive a dose of 40 or 60 mg selinexor oral tablets QW.

DRUG

Selinexor

Participants will receive a dose of 60 mg selinexor oral tablets QW.

OTHER

Placebo

Participants will receive a matching placebo of selinexor oral tablets QW

DRUG

Ruxolitinib

Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID.

Locations (166)

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