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Extended Access of Momelotinib in Adults With Myelofibrosis
Sponsor: GlaxoSmithKline
Summary
The primary objective of this study is to provide extended access and assess long-term safety of momelotinib (MMB) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) enrolled in studies GS-US-352-0101 (NCT01969838), GS-US-352-1214 (NCT02101268), GS-US-352-1154 (NCT02124746), SRA-MMB-301 who are currently receiving treatment with MMB (available as 50mg,100 mg, 150 mg and 200 mg tablets) and have not experienced progression of disease. The secondary objective is to assess overall survival (OS) and leukemia free survival (LFS) in all subjects.
Official title: Extended Access of Momelotinib for Subjects With Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
237
Start Date
2018-05-03
Completion Date
2026-12-31
Last Updated
2024-05-16
Healthy Volunteers
No
Conditions
Interventions
MMB
Tablet(s) administered orally once daily
Locations (224)
IC Irvine Health
Orange, California, United States
GSK Investigational Site
Stanford, California, United States
Stanford Hospital and Clinics
Stanford, California, United States
GSK Investigational Site
Aurora, Colorado, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
GSK Investigational Site
Jacksonville, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
GSK Investigational Site
Atlanta, Georgia, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Northwest Oncology & Hematology - Rolling Meadows
Rolling Meadows, Illinois, United States
GSK Investigational Site
Baltimore, Maryland, United States
Saint Agnes Hospital
Baltimore, Maryland, United States
Dana-Farber Cancer Institute (DFCI)
Boston, Massachusetts, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Rochester, Minnesota, United States
Mayo Clinic - Department of Hematology
Rochester, Minnesota, United States
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
Hackensack, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
GSK Investigational Site
The Bronx, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Portland, Oregon, United States
GSK Investigational Site
Milwaukee, Wisconsin, United States
Mayo Clinic Building - Phoenix
Milwaukee, Wisconsin, United States
Icon Cancer Care Wesley
Hyde Park, Queensland, Australia
GSK Investigational Site
South Brisbane, Queensland, Australia
Flinders Medical Centre
Adelaide, South Australia, Australia
GSK Investigational Site
Adelaide, South Australia, Australia
GSK Investigational Site
Frankston, Victoria, Australia
Frankston Hospital
Frankston, Victoria, Australia
GSK Investigational Site
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
GSK Investigational Site
Parkville, Victoria, Australia
Peter MacCallum Cancer Centre
Parkville, Victoria, Australia
GSK Investigational Site
Perth, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Ordensklinikum Linz Elisabethinen
Linz, Upper Austria, Austria
Medizinische Universität Wien
Vienna, Vienna, Austria
GSK Investigational Site
Linz, Austria
GSK Investigational Site
Vienna, Austria
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
Bruges, West-Vlaanderen, Belgium
GSK Investigational Site
Antwerp, Belgium
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerp, Belgium
GSK Investigational Site
Bruges, Belgium
GSK Investigational Site
Leuven, Belgium
Universitaire Ziekenhuis Leuven
Leuven, Belgium
Centre Hospitalier Universitaire de Liège Site Sart Tilman
Liège, Belgium
GSK Investigational Site
Liège, Belgium
GSK Investigational Site
Pleven, Bulgaria
UMHAT Dr. Georgi Stranski EAD
Pleven, Bulgaria
GSK Investigational Site
Rousse, Bulgaria
Multiprofile Hospital for Active Treatment Ruse
Rousse, Bulgaria
GSK Investigational Site
Sofia, Bulgaria
National Specialized Hospital for Active Treatment of Haematologic Diseases
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment St. Ivan Rilski
Sofia, Bulgaria
GSK Investigational Site
Sofia, Bulgaria
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Montreal, Quebec, Canada
Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada
GSK Investigational Site
Montreal, Quebec, Canada
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Canada
Princess Margaret Cancer Centre
Toronto, Canada
Aalborg University Hospital
Aalborg, Denmark
GSK Investigational Site
Aalborg, Denmark
GSK Investigational Site
Copenhagen, Denmark
Gentofte Hospital
Herlev, Denmark
Centre Hospitalier Le Mans
Le Mans, Pays de la Loire Region, France
GSK Investigational Site
Le Mans, France
CHRU Huriez Lille
Lille, France
GSK Investigational Site
Marseille, France
Institut Paoli Calmettes
Marseille, France
GSK Investigational Site
Paris, France
GSK Investigational Site
Pessac, France
Hôpital Haut-Lévêque
Pessac, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
GSK Investigational Site
Pierre-Bénite, France
GSK Investigational Site
Toulouse, France
Institut Universitaire du Cancer
Toulouse, France
Hopital Saint-Louis
Paris, Île-de-France Region, France
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany
GSK Investigational Site
Aachen, North Rhine-Westphalia, Germany
Universitätsklinikum Aachen
Aachen, North Rhine-Westphalia, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, Germany
GSK Investigational Site
Dresden, Saxony, Germany
GSK Investigational Site
Leipzig, Saxony, Germany
GSK Investigational Site
Halle, Saxony-Anhalt, Germany
Universitätsklinikum Halle
Halle, Saxony-Anhalt, Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Schleswig-Holstein, Germany
University Hospital of Cologne
Cologne, Germany
Universitätsklinikum Dresden
Dresden, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Johannes Gutenberg-Universität Mainz
Mainz, Germany
Petz Aladár Egyetemi Oktató Kórház - Győr
Győr, Győr-Moson-Sopron, Hungary
Szent Borbála Kórház
Tatabánya, Komárom-Esztergom, Hungary
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet
Budapest, Pest County, Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
GSK Investigational Site
Budapest, Hungary
Semmelweis Egyetem I. sz. Belgyogyaszati Klinika, Hematologia
Budapest, Hungary
GSK Investigational Site
Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Haematologiai Tanszek
Debrecen, Hungary
GSK Investigational Site
Debrecen, Hungary
GSK Investigational Site
Győr, Hungary
GSK Investigational Site
Kaposvár, Hungary
Somogy Megyei Kaposi Mor Oktató Kórház
Kaposvár, Hungary
GSK Investigational Site
Nyíregyháza, Hungary
GSK Investigational Site
Tatabánya, Hungary
GSK Investigational Site
Afula, Israel
Emek Medical Center
Afula, Israel
Barzilai Medical Center, Hematology Institute
Ashkelon, Israel
GSK Investigational Site
Ashkelton, Israel
Carmel Medical Center
Haifa, Israel
GSK Investigational Site
Haifa, Israel
GSK Investigational Site
Jerusalem, Israel
Hadassh Medical Organization
Jerusalem, Israel
Meir Medical Center
Kfar Saba, Israel
GSK Investigational Site
Kfar Saba, Israel
GSK Investigational Site
Rionero in Vulture (Pz), Basilicate, Italy
GSK Investigational Site
Naples, Campania, Italy
GSK Investigational Site
Bologna, Emilia-Romagna, Italy
Azienda Ospedaliero - Universitaria Careggi
Florence, Florence, Italy
GSK Investigational Site
Genoa, Liguria, Italy
GSK Investigational Site
Milan, Lombardy, Italy
GSK Investigational Site
Monza (MB), Lombardy, 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
GSK Investigational Site
Turin, Piedmont, Italy
GSK Investigational Site
Torino, Trentino-Alto Adige, Italy
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
Torino, Turin, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, Turin, Italy
GSK Investigational Site
Florence, Tuscany, Italy
GSK Investigational Site
Verona, Veneto, Italy
Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
Bologna, Italy
Azienda Ospedaliera Universitaria San Martino
Genova, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Azienda Ospedaliera Universitaria Federico II
Naples, Italy
GSK Investigational Site
Pesaro, Italy
IRCCS Centro di Riferimento Oncologico di Basilicata
Potenza, Italy
GSK Investigational Site
Roma, Italy
Umberto I - Policlinico di Roma
Roma, Italy
Ospedale Policlinico Giambattista Rossi Borgo Roma
Verona, Italy
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands
GSK Investigational Site
Maastricht, Netherlands
Szpital Wojewódzki w Opolu
Opole, Opole Voivodeship, Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
Brzozów, Podkarpacki, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomoskie, Poland
GSK Investigational Site
Brzozów, Poland
GSK Investigational Site
Chorzów, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich
Chorzów, Poland
GSK Investigational Site
Gdansk, Poland
GSK Investigational Site
Krakow, Poland
GSK Investigational Site
Lublin, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lub
Lublin, Poland
Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Hematologii
Małogoskie, Poland
GSK Investigational Site
Opole, Poland
GSK Investigational Site
Poznan, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA w Poznaniu im. Ledwika Bierkowskiego
Poznan, Poland
GSK Investigational Site
Brasov, Romania
Policlinica de Diagnostic Rapid SA
Brasov, Romania
GSK Investigational Site
Bucharest, Romania
GSK Investigational Site
Bucharest, Romania
Spitalul Clinic Coltea
Bucharest, Romania
Institutul Clinic Fundeni
Bucharest, Romania
GSK Investigational Site
Cluj-Napoca, Romania
Institutul Oncologic Prof. Dr. Ion Chiricuţă
Cluj-Napoca, Romania
GSK Investigational Site
Craiova, Romania
Spitalul Clinic Municipal Filantropia Craiova
Craiova, Romania
GSK Investigational Site
Iași, Romania
Institutul Regional De Oncologie IASI
Iași, Romania
GSK Investigational Site
Singapore, Singapore
Singapore General Hospital
Singapore, Singapore
GSK Investigational Site
Singapore, Singapore
Raffles Hospital
Singapore, Singapore
Inje University Haeundae Paik Hospital
Busan, Busan Gwang'yeogsi [Pusan-Kwangyokshi], South Korea
Kyungpook National University Hospital
Daegu, Daegu Gwang'yeogsi, South Korea
Severance Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea
GSK Investigational Site
Busan, South Korea
GSK Investigational Site
Daegu, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Catholic University of Korea Seoul Saint Mary's Hospital
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
GSK Investigational Site
Barcelona, Spain
Institut Hospital del Mar d'Investigacions Mèdiques
Barcelona, Spain
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
GSK Investigational Site
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
GSK Investigational Site
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Spain
GSK Investigational Site
Majadahonda (Madrid), Spain
Clínica Universidad de Navarra
Pamplona, Spain
GSK Investigational Site
Pamplona, Spain
GSK Investigational Site
Zaragoza, Spain
Hospital de Día Quirónsalud Zaragoza
Zaragoza, Spain
GSK Investigational Site
Kaohsiung City, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
GSK Investigational Site
Kaohsiung City, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
GSK Investigational Site
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital - Linkou Branch
Taoyuan District, Taiwan
GSK Investigational Site
Taoyuan District, Taiwan
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, England, United Kingdom
GSK Investigational Site
Airdrie, Lanarkshire, United Kingdom
NHS Lanarkshire
Airdrie, Scotland, United Kingdom
GSK Investigational Site
Bristol, United Kingdom
GSK Investigational Site
Cardiff, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
GSK Investigational Site
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
GSK Investigational Site
Oxford, United Kingdom
Oxford University Hospitals NHS Trust
Oxford, United Kingdom