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Brief Title: A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM)
Official Title: A Randomized, Double-blind, Phase 3 Study to Evaluate the Activity of Momelotinib (MMB) Versus Danazol (DAN) in Symptomatic, Anemic Subjects With Primary Myelofibrosis (PMF), Post-polycythemia Vera (PV) Myelofibrosis, or Post-essential Thrombocythemia (ET) Myelofibrosis Who Were Previously Treated With JAK Inhibitor Therapy
Study ID: NCT04173494
Brief Summary: MOMENTUM is a randomized, double-blind, active control Phase 3 trial intended to confirm the differentiated clinical benefits of the investigational drug momelotinib (MMB) versus danazol (DAN) in symptomatic and anemic participants who have previously received an approved Janus kinase inhibitor (JAKi) therapy for myelofibrosis (MF). The purpose of this clinical study is to compare the effectiveness and safety of MMB to DAN in treating and reducing: 1) disease related symptoms, 2) the need for blood transfusions and 3) splenomegaly, in adults with primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF. The study is planned in countries including, but not limited to: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom (UK) and United States (US). Participants must be symptomatic with a Myelofibrosis Symptom Assessment Form (MFSAF) version (v) 4.0 Total Symptom Score of \>= 10 at screening, and be anemic with hemoglobin (Hgb) \< 10 gram/deciliter (g/dL). For participants with ongoing JAKi therapy at screening, JAKi therapy must be tapered over a period of at least 1 week, followed by a 2-week non-treatment washout interval prior to randomization. Participants will be randomized 2:1 to orally self-administer blinded treatment: MMB plus placebo or DAN plus placebo. Participants randomized to receive MMB who complete the randomized treatment period to the end of Week 24 may continue to receive MMB in the open-label extended treatment period to the end of Week 204 (a total period of treatment of approximately 4 years) if the participants tolerates and continues to benefit from MMB. Participants randomized to receive DAN may cross-over to MMB open-label treatment in the following circumstances: at the end of Week 24 if they complete the randomized treatment period; or at the end of Week 24 if they discontinue treatment with DAN but continue study assessments and do not receive prohibited medications including alternative active anti-MF therapy; or at any time during the randomized treatment period if they meet the protocol-defined criteria for radiographically confirmed symptomatic splenic progression. Participants randomized to receive DAN who are receiving clinical benefit at the end of Week 24 may choose to continue DAN therapy up to Week 48. The comparator treatment, DAN, is an approved medication in the US and in some other countries and is recommended by national guidelines as a treatment for anemia in MF.
Detailed Description: MOMENTUM Contact Email: GSKClinicalSupportHD@gsk.com
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic Hospital - Phoenix, Phoenix, Arizona, United States
Irvine Center for Clinical Research, Irvine, California, United States
Norris Comprehensive Cancer Center, Los Angeles, California, United States
American Institute of Research - Whittier, Whittier, California, United States
University of Colorado Hospital Anschutz Cancer Pavilion, Aurora, Colorado, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
Moffitt Cancer Center, Tampa, Florida, United States
Northwest Oncology & Hematology - Rolling Meadows, Rolling Meadows, Illinois, United States
Washington University School of Medicine in Saint Louis, Saint Louis, Missouri, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Columbia University Irving Medical Center - Presbyterian Hospital, New York, New York, United States
Cleveland Clinic - Richard E. Jacobs Health Center, Avon, Ohio, United States
Gabrail Cancer Center, Canton, Ohio, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Allegheny Health Network, Pittsburgh, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
The University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Canberra Region Cancer Centre, Garran, Australian Capital Territory, Australia
Calvary Mater Newcastle Hospital, Waratah, New South Wales, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Perth Radiological Clinic - Magnetic Resonance Centre, Perth, Western Australia, Australia
Medizinische Universität Innsbruck, Innsbruck, Tyrol, Austria
Ordensklinikum Linz Elisabethinen, Linz, Upper Austria, Austria
Medizinische Universität Wien, Wien, Vienna, Austria
Oberösterreichische Gesundheitsholding GmbH, Steyr, , Austria
Hôpital Erasme, Bruxelles, Brussels, Belgium
Grand Hôpital de Charleroi - Notre Dame, Charleroi, Hainaut, Belgium
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan, Brugge, West-Vlaanderen, Belgium
Ziekenhuis Netwerk Antwerpen Stuivenberg, Antwerpen, , Belgium
Centre Hospitalier Universitaire de Liège, Liège, , Belgium
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD, Pleven, , Bulgaria
University Hospital St. Ivan Rilski, Sofia, , Bulgaria
University Multiprofile Hospital For Active Treatment Aleksandrovska, Sofia, , Bulgaria
National Specialized Hospital for Active Treatment of Haematologic Diseases, Sofia, , Bulgaria
Saint Paul's Hospital, Vancouver, British Columbia, Canada
Queen Elizabeth II Health Sciences Centre - Halifax Infirmary, Halifax, Nova Scotia, Canada
McMaster University Medical Center, Hamilton, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Research Institute of the McGill University Health Centre, Montréal, Quebec, Canada
Hôpital de l'Enfant-Jésus, Québec, , Canada
Fakultni Nemocnice Brno, Brno, Jihormoravsky Kraj, Czechia
Herlev Hospital, Herlev, Hovedstaden, Denmark
Aalborg Universitetshospital - Syd, Aalborg, Nordjylland, Denmark
Sjællands Universitetshospital - Roskilde, Roskilde, Sjælland, Denmark
Odense Universitetshospital, Odense, Syddanmark, Denmark
Hôpital Haut-Lévêque, Pessac, Aquitaine, France
Hospital Center University Of Caen Normandie, Caen, Basse-Normandie, France
Hôpital Claude Huriez, Lille, Hauts-de-France, France
Hôpital Saint-Louis, Paris, Ile-de-France, France
Hôpital Saint-Antoine, Paris, Ile-de-France, France
Centre Hospitalier Universitaire Limoges, Limoges, Limousin, France
Centre Hospitalier De Lens, Lens, Nord Pas-Des-Calais, France
Centre Hospitalier Le Mans, Le Mans, Pays De La Loire, France
Centre Hospitalier Universitaire Amiens-Picardie - Site Sud, Amiens, Picardie, France
Hôpital l'Archet, Nice, Provence-Alpes-Côte d'Azur, France
Centre Hospitalier Lyon-Sud, Pierre-Bénite, Rhone-Alps, France
Centre Hosptitalier Universitaire Angers, Angers, , France
Hôpital Saint-Vincent De Paul - Lille, Lille, , France
Hôpital De La Conception, Marseille, , France
Hôpital Emile Muller, Mulhouse, , France
Centre Hospitalier Universitaire Nantes - Hôtel Dieu, Nantes, , France
Centre Hospitalier Universitaire de Poitiers, Poitiers, , France
Universitätsklinikum Aachen, Aachen, Nordrhein-Westfalen, Germany
Universitätsklinikum Essen, Essen, Nordrhein-Westfalen, Germany
Johannes Wesling Klinikum Minden, Minden, Nordrhein-Westfalen, Germany
Universitätsklinikum Halle, Halle, Sachsen-Anhalt, Germany
Universitätsklinikum Carl Gustav Carus Dresden, Dresden, Sachsen, Germany
Universitätsklinikum Leipzig, Leipzig, Sachsen, Germany
Universitätsklinikum Jena, Jena, Thuringen, Germany
Uniklinik Köln, Köln, , Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck, Lübeck, , Germany
Kliniken Ostalb - Stauferklinikum Schwäbisch Gmünd, Mutlangen, , Germany
Pécsi Tudományegyetem Klinikai Központ, Pécs, Baranya, Hungary
Debreceni Egyetem Klinikai Központ, Debrecen, Hajdu-Bihar, Hungary
Szent Borbála Kórház, Tatabánya, Komárom-Esztergom, Hungary
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet - Szent László Telephely, Budapest, Pest, Hungary
Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár, Somogy, Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház, Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Markusovszky Egyetemi Oktatókórház Szombathely, Szombathely, Vas, Hungary
Semmelweis Egyetem, Budapest, , Hungary
Petz Aladár Megyei Oktató Kórház, Győr, , Hungary
Yitzhak Shamir Medical Center, Be'er Ya'aqov, Central District, Israel
Bnai Zion Medical Center, Haifa, Haifa District, Israel
Hadassah University Hospital Ein Kerem, Jerusalem, Jerusalem District, Israel
Rambam Health Care Campus, Haifa, , Israel
Carmel Medical Center, Haifa, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
Meir Medical Center, Kfar Saba, , Israel
Western Galilee Hospital-Nahariya, Nahariya, , Israel
Rabin Medical Center - Beilinson Hospital, Petah tikva, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Azienda Ospedaliero - Universitaria Careggi, Firenze, Florence, Italy
Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Forli-Cesena, Italy
Azienda Socio Sanitaria Territoriale Monza - Ospedale San Gerardo, Monza, Monza E Brianza, Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Pesaro E Urbino, Italy
IRCCS Centro di Riferimento Oncologico di Basilicata, Rionero In Vulture, Potenza, Italy
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino, Torino, Turin, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino, Torino, Turin, Italy
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo - Alessandria, Alessandria, , Italy
Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi, Bologna, , Italy
Ospedale Policlinico San Martino, Genova, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, , Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milano, , Italy
Azienda Ospedaliera Universitaria Federico II, Napoli, , Italy
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara, Novara, , Italy
Umberto I - Policlinico di Roma, Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli, Roma, , Italy
Presidio Ospedaliero Universitario Santa Maria della Misericordia, Udine, , Italy
Ospedale di Circolo e Fondazione Macchi, Varese, , Italy
Ospedale Policlinico Giambattista Rossi Borgo Roma, Verona, , Italy
Kyungpook National University Hospital, Daegu, Daegu Gwang'yeogsi, Korea, Republic of
Inje University Busan Paik Hospital, Busan, , Korea, Republic of
Inje University Haeundae Paik Hospital, Busan, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
The Catholic University of Korea Seoul Saint Mary's Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Ulsan University Hospital, Ulsan, , Korea, Republic of
North Shore Hospital, Auckland, , New Zealand
Middlemore Clinical Trials, Auckland, , New Zealand
Klinika Hematologii Nowotworów Krwi i Transplantacji Szpiku, Wrocław, Dolnoslaskie, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie, Lublin, Lubelskie, Poland
Szpital Uniwersytecki w Krakowie, Kraków, Malopolskie, Poland
Instytut Hematologii I Transfuzjologii, Warszawa, Mazowieckie, Poland
Alvamed Zakład Specjalistycznej Opieki Zdrowotnej, Warszawa, Mazowieckie, Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie, Kraków, Małopolskie, Poland
Szpital Wojewódzki w Opolu, Opole, Opolskie, Poland
Uniwersyteckie Centrum Kliniczne w Gdańsku, Gdańsk, Pomorskie, Poland
Silesian Healthy Blood Clinic, Chorzów, Salskie, Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi, Łódź, , Poland
Spitalul Filantropia - Craiova, Craiova, Dolj, Romania
Institutul Regional De Oncologie Iasi, Iaşi, Iasi County, Romania
Spitalul Clinic Judetean De Urgenta Târgu Mureș, Târgu-Mureş, Mureș, Romania
Laboratul clinic MedLife-Policlinica de Diagnostic Rapid Brasov, Braşov, , Romania
Coltea - Spital Clinic, Bucharest, , Romania
Singapore General Hospital, Singapore, , Singapore
Tan Tock Seng Hospital, Singapore, , Singapore
Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
Institut Hospital del Mar d'Investigacions Mèdiques, Barcelona, , Spain
Hospital Universitari Vall d'Hebrón, Barcelona, , Spain
Hospital Germans Trias i Pujol, Barcelona, , Spain
Hospital San Pedro de Alcantara, Cáceres, , Spain
Institut Català d'Oncologia Girona, Girona, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Virgen de la Victoria, Málaga, , Spain
Complejo Asistencial Universitario de Salamanca - Hospital Clínico, Salamanca, , Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
Hospital Universitario La Fe, Valencia, , Spain
Hospital de Día Quirónsalud Zaragoza, Zaragoza, , Spain
Karolinska Universitetssjukhuset Solna, Solna, Stockholm, Sweden
Sahlgrenska Universitetssjukhuset, Göteborg, Västra Götalands Län, Sweden
Uddevalla Sjukhus, Uddevalla, , Sweden
Chiayi Chang Gung Memorial Hospital, Puzi City, Chaiyi, Taiwan
China Medical University Hospital, Taichung City, Taichung, Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital - Linkou Branch, Taoyuan, , Taiwan
United Lincolnshire Hospitals NHS Trust, Boston, England, United Kingdom
University Hospitals Bristol NHS Foundation Trust, Bristol, England, United Kingdom
University College London Hospitals NHS Foundation Trust, London, England, United Kingdom
Guy's and Saint Thomas' NHS Foundation Trust, London, England, United Kingdom
Imperial College Healthcare NHS Trust, London, England, United Kingdom
University Hospital Southampton NHS Foundation Trust, Southampton, England, United Kingdom
NHS Lanarkshire, Airdrie, Scotland, United Kingdom
Name: Srdan Verstovsek, M.D., Ph.D.
Affiliation: Department of Leukemia, The University of Texas MD Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Ruben Mesa
Affiliation: UT Health San Antonio Cancer Center, San Antonio, TX, USA
Role: PRINCIPAL_INVESTIGATOR