A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM)

PHASE3CompletedINTERVENTIONAL
Enrollment

195

Participants

Timeline

Start Date

February 7, 2020

Primary Completion Date

December 3, 2021

Study Completion Date

December 29, 2022

Conditions
Primary MyelofibrosisPost-polycythemia Vera MyelofibrosisPost-essential Thrombocythemia Myelofibrosis
Interventions
DRUG

Momelotinib

Momelotinib tablets will be self-administered orally once daily

DRUG

Placebo to match danazol

Danazol placebo capsules will be self-administered orally twice daily

DRUG

Danazol

Danazol capsules will be self-administered orally twice daily

DRUG

Placebo to match momelotinib

Momelotinib placebo tablets will be self-administered orally once daily

Trial Locations (167)

333

Chang Gung Memorial Hospital - Linkou Branch, Taoyuan District

613

Chiayi Chang Gung Memorial Hospital, Buzi

1070

Hôpital Erasme, Brussels

1083

Semmelweis Egyetem, Budapest

1090

Medizinische Universität Wien, Vienna

1097

Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet - Szent László Telephely, Budapest

1431

University Hospital St. Ivan Rilski, Sofia

University Multiprofile Hospital For Active Treatment Aleksandrovska, Sofia

1756

National Specialized Hospital for Active Treatment of Haematologic Diseases, Sofia

2025

Middlemore Clinical Trials, Auckland

2060

Ziekenhuis Netwerk Antwerpen Stuivenberg, Antwerp

2298

Calvary Mater Newcastle Hospital, Waratah

2605

Canberra Region Cancer Centre, Garran

2730

Herlev Hospital, Herlev

2800

Szent Borbála Kórház, Tatabánya

3004

The Alfred Hospital, Melbourne

4000

Sjællands Universitetshospital - Roskilde, Roskilde

4020

Ordensklinikum Linz Elisabethinen, Linz

4032

Debreceni Egyetem Klinikai Központ, Debrecen

4400

Oberösterreichische Gesundheitsholding GmbH, Steyr

Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház, Nyíregyháza

5000

Odense Universitetshospital, Odense

5042

Flinders Medical Centre, Bedford Park

5800

University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD, Pleven

6000

Perth Radiological Clinic - Magnetic Resonance Centre, Perth

Grand Hôpital de Charleroi - Notre Dame, Charleroi

6020

Medizinische Universität Innsbruck, Innsbruck

7400

Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár

7624

Pécsi Tudományegyetem Klinikai Központ, Pécs

8000

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

9000

Aalborg Universitetshospital - Syd, Aalborg

9023

Petz Aladár Megyei Oktató Kórház, Győr

9700

Markusovszky Egyetemi Oktatókórház Szombathely, Szombathely

10002

National Taiwan University Hospital, Taipei

10003

Hospital San Pedro de Alcantara, Cáceres

10032

Columbia University Irving Medical Center - Presbyterian Hospital, New York

10126

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

10128

Azienda Ospedaliera Ordine Mauriziano di Torino, Torino

13385

Hôpital De La Conception, Marseille

13620

Seoul National University Bundang Hospital, Seongnam-si

14033

Hospital Center University Of Caen Normandie, Caen

15121

Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo - Alessandria, Alessandria

15224

Allegheny Health Network, Pittsburgh

16132

Ospedale Policlinico San Martino, Genova

17007

Institut Català d'Oncologia Girona, Girona

20057

Georgetown University Medical Center, Washington D.C.

20122

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

20123

Fondazione Policlinico Universitario Agostino Gemelli, Roma

20162

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milan

20900

Azienda Socio Sanitaria Territoriale Monza - Ospedale San Gerardo, Monza

21100

Ospedale di Circolo e Fondazione Macchi, Varese

23538

Universitätsklinikum Schleswig-Holstein - Campus Lübeck, Lübeck

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

31048

Bnai Zion Medical Center, Haifa

32429

Johannes Wesling Klinikum Minden, Minden

33011

Hospital Universitario Central de Asturias, Oviedo

33100

Presidio Ospedaliero Universitario Santa Maria della Misericordia, Udine

33604

Hôpital Haut-Lévêque, Pessac

33612

Moffitt Cancer Center, Tampa

37007

Complejo Asistencial Universitario de Salamanca - Hospital Clínico, Salamanca

37134

Ospedale Policlinico Giambattista Rossi Borgo Roma, Verona

40138

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

40447

China Medical University Hospital, Taichung

41013

Hospital Universitario Virgen del Rocío, Seville

41944

Kyungpook National University Hospital, Daegu

44000

Centre Hospitalier Universitaire Nantes - Hôtel Dieu, Nantes

44011

Cleveland Clinic - Richard E. Jacobs Health Center, Avon

44033

Ulsan University Hospital, Ulsan

44106

University Hospitals Cleveland Medical Center, Cleveland

44718

Gabrail Cancer Center, Canton

45147

Universitätsklinikum Essen, Essen

45153

Uddevalla Sjukhus, Uddevalla

46009

Hospital Universitario La Fe, Valencia

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola

47392

Inje University Busan Paik Hospital, Busan

48108

Inje University Haeundae Paik Hospital, Busan

50012

Hospital de Día Quirónsalud Zaragoza, Zaragoza

50134

Azienda Ospedaliero - Universitaria Careggi, Florence

50937

Uniklinik Köln, Cologne

52074

Universitätsklinikum Aachen, Aachen

59000

Hôpital Saint-Vincent De Paul - Lille, Lille

59037

Hôpital Claude Huriez, Lille

60008

Northwest Oncology & Hematology - Rolling Meadows, Rolling Meadows

61121

Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro

62307

Centre Hospitalier De Lens, Lens

63110

Washington University School of Medicine in Saint Louis, St Louis

68100

Hôpital Emile Muller, Mulhouse

69495

Centre Hospitalier Lyon-Sud, Pierre-Bénite

71013

Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo

72037

Centre Hospitalier Le Mans, Le Mans

73557

Kliniken Ostalb - Stauferklinikum Schwäbisch Gmünd, Mutlangen

75010

Hôpital Saint-Louis, Paris

75571

Hôpital Saint-Antoine, Paris

77030

The University of Texas MD Anderson Cancer Center, Houston

78229

The University of Texas Health Science Center at San Antonio, San Antonio

80045

University of Colorado Hospital Anschutz Cancer Pavilion, Aurora

80054

Centre Hospitalier Universitaire Amiens-Picardie - Site Sud, Amiens

80131

Azienda Ospedaliera Universitaria Federico II, Napoli

85028

IRCCS Centro di Riferimento Oncologico di Basilicata, Rionero in Vulture

85054

Mayo Clinic Hospital - Phoenix, Phoenix

86021

Centre Hospitalier Universitaire de Poitiers, Poitiers

87042

Centre Hospitalier Universitaire Limoges, Limoges

90603

American Institute of Research - Whittier, Whittier

91011

Norris Comprehensive Cancer Center, Los Angeles

92614

Irvine Center for Clinical Research, Irvine

169608

Singapore General Hospital, Singapore

200143

Spitalul Filantropia - Craiova, Craiova

308433

Tan Tock Seng Hospital, Singapore

500366

Laboratul clinic MedLife-Policlinica de Diagnostic Rapid Brasov, Brasov

540136

Spitalul Clinic Judetean De Urgenta Târgu Mureș, Târgu Mureş

700483

Institutul Regional De Oncologie Iasi, Iași

3109601

Rambam Health Care Campus, Haifa

3436212

Carmel Medical Center, Haifa

4428164

Meir Medical Center, Kfar Saba

4941492

Rabin Medical Center - Beilinson Hospital, Petah Tikva

7030000

Yitzhak Shamir Medical Center, Be’er Ya‘aqov

9103102

Shaare Zedek Medical Center, Jerusalem

07601

Hackensack University Medical Center, Hackensack

B-4000

Centre Hospitalier Universitaire de Liège, Liège

V6Z 1Y6

Saint Paul's Hospital, Vancouver

B3H 1V7

Queen Elizabeth II Health Sciences Centre - Halifax Infirmary, Halifax

L8V 5C2

McMaster University Medical Center, Hamilton

M5G 2M9

Princess Margaret Cancer Centre, Toronto

H3H 2R9

Research Institute of the McGill University Health Centre, Montreal

G1J 1Z4

Hôpital de l'Enfant-Jésus, Québec

625 00

Fakultni Nemocnice Brno, Brno

06200

Hôpital l'Archet, Nice

49 933

Centre Hosptitalier Universitaire Angers, Angers

01307

Universitätsklinikum Carl Gustav Carus Dresden, Dresden

04103

Universitätsklinikum Leipzig, Leipzig

06120

Universitätsklinikum Halle, Halle

07747

Universitätsklinikum Jena, Jena

Unknown

Hadassah University Hospital Ein Kerem, Jerusalem

Western Galilee Hospital-Nahariya, Nahariya

Tel Aviv Sourasky Medical Center, Tel Aviv

Samsung Medical Center, Seoul

Seoul National University Hospital, Seoul

00161

Umberto I - Policlinico di Roma, Roma

0622

North Shore Hospital, Auckland

31-501

Szpital Uniwersytecki w Krakowie, Krakow

31-826

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie, Krakow

50-367

Klinika Hematologii Nowotworów Krwi i Transplantacji Szpiku, Wroclaw

20-081

Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie, Lublin

02-776

Instytut Hematologii I Transfuzjologii, Warsaw

03-401

Alvamed Zakład Specjalistycznej Opieki Zdrowotnej, Warsaw

45-064

Szpital Wojewódzki w Opolu, Opole

80-214

Uniwersyteckie Centrum Kliniczne w Gdańsku, Gdansk

41-503

Silesian Healthy Blood Clinic, Chorzów

93-513

Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi, Lodz

030 171

Coltea - Spital Clinic, Bucharest

03722

Severance Hospital, Seoul

06591

The Catholic University of Korea Seoul Saint Mary's Hospital, Seoul

08003

Institut Hospital del Mar d'Investigacions Mèdiques, Barcelona

08035

Hospital Universitari Vall d'Hebrón, Barcelona

08916

Hospital Germans Trias i Pujol, Barcelona

171 76

Karolinska Universitetssjukhuset Solna, Solna

413 45

Sahlgrenska Universitetssjukhuset, Gothenburg

PE21 9QS

United Lincolnshire Hospitals NHS Trust, Boston

BS2 8ED

University Hospitals Bristol NHS Foundation Trust, Bristol

NW1 2PG

University College London Hospitals NHS Foundation Trust, London

SE1 9RT

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

W12 0HS

Imperial College Healthcare NHS Trust, London

SO16 6YD

University Hospital Southampton NHS Foundation Trust, Southampton

ML6 0JS

NHS Lanarkshire, Airdrie

All Listed Sponsors
lead

Sierra Oncology LLC - a GSK company

INDUSTRY

NCT04173494 - A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM) | Biotech Hunter | Biotech Hunter