Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

353

Participants

Timeline

Start Date

March 11, 2021

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2028

Conditions
Myelofibrosis
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.

Trial Locations (166)

1088

Semmelweis Egyetem, Budapest

1431

University Multiprofile Hospital for Active Treatment Aleksandrovska, Sofia

University Multiprofile Hospital for Active Treatment St. Ivan Rilski, Sofia

1797

Specialized Hospital for Active Treatment of Hematological Diseases - EAD Sofia, Sofia

2030

ZNA Stuivenberg - Satelite, Antwerp

2060

ZNA Stuivenberg, Antwerp

2170

Liverpool Hospital, Liverpool

2200

Bankstown-Lidcombe Hospital, Bankstown

2560

Campbelltown Hospital, Campbelltown

3000

Universitair Ziekenhuis Leuven - Campus Gasthuisberg, Leuven

4002

University Multiprofile Hospital for Active Treatment Sveti George - Base 1, Plovdiv

4101

Icon Cancer Centre - Wesley, South Brisbane

5000

Royal Adelaide Hospital, Adelaide

6003

University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich, Stara Zagora

6009

One Clinical Research, Nedlands

6120

Universitätsklinikum Halle, Halle

6351

Samsung Medical Center, Seoul

7747

Universitätsklinikum Jena, Jena

8000

Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan, Bruges

8200

Aarhus Universitetshospital, Aarhus N

9000

Universitair Ziekenhuis Gent, Ghent

Tang Severinsen, Marianne, Aalborg

9023

Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház, Győr

10003

Hospital San Pedro de Alcantara, Cáceres

10029

Mount Sinai Health System, New York

10048

National Taiwan University Hospital, Taipei

10065

Memorial Sloan Kettering Cancer Center, New York

10126

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

10128

Azienda Ospedaliera Ordine Mauriziano di Torino, Torino

13605

Seoul National University Bundang Hospital, Seongnam-si

16132

IRCCS Ospedale Policlinico San Martino, Genova

17007

Institut Català d'Oncologia Girona (ICO Girona), Girona

20007

Georgetown Lombardi Comprehensive Center, Washington D.C.

20122

Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Milan

20125

Spitalul Clinic Colentina, Bucharest

20141

Istituto Europeo di Oncologia, Milan

20155

USOR - Virginia Cancer Specialists - Gainesville Office, Gainesville

20162

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milan

20850

Maryland Oncology Hematology-Satellite, Rockville

20900

Fondazione IRCCS San Gerardo dei Tintori, Monza

20904

Maryland Oncology Hematology-Satellite, Silver Spring

21004

Maryland Oncology Hematology-Satellite, Brandywine

21044

Maryland Oncology Hematology, Columbia

21205

The Sidney Kimmel Comprehensive Cancer Center, Baltimore

21401

Maryland Oncology Hematology-Satellite, Annapolis

23298

VCU Massey Cancer Center, Richmond

23456

USOR - Virginia Oncology Associates - Virginia Beach, Virginia Beach

24116

Städtisches Krankenhaus Kiel, Kiel

26003

West Virginia University Cancer Institute, Wheeling Hospital, Wheeling

27003

Hospital Universitario Lucus Augusti, Lugo

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

27705

Duke Cancer Institue, Durham

28007

Hospital General Universitario Gregorio Marañón, Madrid

28034

Hospital Universitario Ramón y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28100

Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara, Novara

29010

Hospital Universitario Virgen de la Victoria, Málaga

29200

Hôpital Morvan, Brest

30029

Chu De Nîmes - Institut De Cancérologie Du Gard, Nîmes

30120

Hospital Clínico Universitario Virgen de la Arrixaca, Murcia

33000

Institut Bergonié, Bordeaux

33011

Hospital Universitario Central de Asturias, Oviedo

33305

Chang Gung Memorial Hospital - Linkou Branch, Taoyuan District

35010

Hospital Universitario de Gran Canaria Doctor Negrin, Las Palmas de Gran Canaria

35294

UAB Division of Hematology/Oncology, Birmingham

37007

Complejo Asistencial Universitario de Salamanca - Hospital Clínico, Salamanca

37044

Hôpital Bretonneau, Tours

37134

Centro Ricerche Cliniche di Verona, Verona

37232

Vanderbilt Ingram Cancer Center, Nashville

40138

Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi, Bologna

40207

Norton Cancer Institute - Saint Matthews, Louisville

40447

China Medical University Hospital, Taichung

40479

Marien Hospital Düsseldorf, Düsseldorf

41110

University General Hospital of Larissa, Hematology Department, Larissa

41944

Kyungpook National University Hospital, Daegu

42271

Centre Hospitalier Universitaire de Saint-Étienne, Saint-Priest-en-Jarez

43210

Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute, Columbus

43214

OhioHealth, Columbus

45242

USOR - Oncology Hematology Care - Kenwood, Cincinnati

46010

Hospital Clínico Universitario de Valencia, Valencia

47014

"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST", Meldola

49241

Pusan National University Hospital, Busan

49444

The Cancer & Hematology Centers of Muskegon, Norton Shores

49546

The Cancer & Hematology Centers -Satellite Site, Grand Rapids

50012

Hospital de Día Quirónsalud Zaragoza, Zaragoza

50134

Azienda Ospedaliero - Universitaria Careggi, Florence

53792

University of Wisconsin - Madison, Madison

58128

Chonnam National University Hwasun Hospital, Hwasun

59037

Hôpital Huriez, Lille

63003

Centre Hospitalier Universitaire Estaing, Clermont-Ferrand

68100

Hôpital Emile Muller, Mulhouse

69495

Centre Hospitalier Lyon-Sud, Pierre-Bénite

73557

Kliniken Ostalb - Stauferklinikum Schwäbisch Gmünd, Mutlangen

75010

Hôpital Saint-Louis, Paris

75013

Hôpital Universitaire Pitié Salpêtrière, Paris

75014

Hôpital Cochin, Paris

75246

Texas Oncology, Dallas

77030

University of Texas MD Anderson Cancer Center, Houston

80045

USOR - Rocky Mountain Cancer Centers - Aurora, Aurora

80756

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

83301

Chang Gung Memorial Hospital - Kaohsiung Branch, Kaohsiung City

84112

Huntsman Cancer Institute, Salt Lake City

85028

IRCCS Centro di Riferimento Oncologico di Basilicata, Rionero in Vulture

90095

UCLA, Los Angles

90210

UCLA - Satellite Site, Beverly Hills

91010

City of Hope, Duarte

91105

The Oncology Institute of Hope & Innovation, Pasadena

92618

City of Hope - Irvine Lennar - Satellite, Irvine

93003

UCLA - Satellite Site, Encino

95123

Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco - Catania/ Presidio G. Rodolico, Catania

98109

Fred Hutchinson Cancer Center - SCAA South Lake Union, Seattle

200136

Spitalul Filantropia - Craiova, Craiova

400015

Institutul Oncologic Prof. Dr. Ion Chiricuta, Cluj-Napoca

540136

Spitalul Clinic Judetean De Urgenta Târgu Mureș, Târgu Mureş

700483

Institutul Regional De Oncologie Iasi, Iași

1834111

Emek Medical Center, Afula

2210001

Western Galilee Hospital-Nahariya, Nahariya

3109601

Rambam Health Care Campus, Haifa

3436212

Carmel Medical Center, Haifa

5265601

The Chaim Sheba Medical Center, Ramat Gan

6423906

Tel Aviv Sourasky Medical Center, Tel Aviv

7030000

Shamir Medical Center (Assaf Harofeh), Be’er Ya‘aqov

9112001

Hadassah University Hospital - Mount Scopus - Satellite Site, Jerusalem

Hadassah University Hospital Ein Kerem, Jerusalem

06511

Smilow Cancer Hospital - New Haven, New Haven

07601

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack

T6G 2G3

University of Alberta Hospital, Edmonton

L1G 2B9

Lakeridge Health, Oshawa

H4A 3J1

Research Institute of the McGill University Health Centre, Montreal

128 08

Vseobecna Fakultni Nemocnice v Praze, Prague

500 05

Fakultní Nemocnice Hradec Králové, Hradec Králové

779 00

Fakultní Nemocnice Olomouc, Olomouc

06202

Hôpital l'Archet - CHU Nice, Nice

49 933

Centre Hospitalier Universitaire d'Angers, Angers

115 27

Laiko General Hospital of Athens, Athens

115 28

"General Hospital of Athens Alexandra", Athens

124 62

University General Hospital Attikon, Athens

570 10

General Hospital of Thessaloniki George Papanikolaou, Thessaloniki

455 00

University General Hospital of Ioannina, Ioánnina

00161

Umberto I - Policlinico di Roma, Roma

00128

Università Campus Bio-Medico di Roma, Rome

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma

2134 TM

Spaarne Gasthuis - Hoofddorp, Hoofddorp

9713 GZ

Universitair Medisch Centrum Groningen, Groningen

60-185

AIDPORT, Skórzewo

87-100

Medicover Integrated Clinical Services (MICS) - Centrum Medyczne Toruń, Torun

53-439

Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku, Wroclaw

20-093

Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie, Lublin

36-200

Szpital Specjalistyczny w Brzozowie - Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza, Brzozów

80-952

Uniwersyteckie Centrum Kliniczne w Gdańsku, Gdansk

40-519

Pratia Onkologia Katowice, Katowice

58-309

Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu, Wałbrzych

020125

Coltea - Spital Clinic, Bucharest

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Seoul

06591

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

08916

Institut Català d'Oncologia Badalona, Badalona

08035

Hospital Universitari Vall d'Hebrón, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

SE1 9RT

Guy's and St Thomas' NHS Foundation Trust, London

OX3 7LE

Oxford University Hospitals NHS Foundation Trust, Oxford

PE21 9QS

United Lincolnshire Hospitals NHS Trust-Satellite Site, Boston

United Lincolnshire Hospitals NHS Trust, Boston

LZ 8XP

The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool

W12 0HS

Imperial College Healthcare NHS Trust, London

NE7 7DN

The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne

Sponsors
All Listed Sponsors
lead

Karyopharm Therapeutics Inc

INDUSTRY