Spots Global Cancer Trial Database for Extended Access of Momelotinib in Adults With Myelofibrosis
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Trial Identification
Brief Title: Extended Access of Momelotinib in Adults With Myelofibrosis
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)
Study ID: NCT03441113
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Saint Louis, Missouri, United States
GSK Investigational Site, Saint Louis, Missouri, United States
GSK Investigational Site, Hackensack, New Jersey, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
GSK Investigational Site, Bronx, New York, United States
Montefiore Medical Center, 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, Wien, Vienna, Austria
GSK Investigational Site, Linz, , Austria
GSK Investigational Site, Wien, , Austria
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan, Brugge, West-Vlaanderen, Belgium
GSK Investigational Site, Antwerpen, , Belgium
Ziekenhuis Netwerk Antwerpen Stuivenberg, Antwerp, , Belgium
GSK Investigational Site, Brugge, , 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, Ruse, , Bulgaria
Multiprofile Hospital for Active Treatment Ruse, Ruse, , 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
GSK Investigational Site, Montreal, Quebec, Canada
Research Institute of the McGill University Health Centre, Montréal, Quebec, Canada
Sir Mortimer B. Davis Jewish General Hospital, Montréal, , Canada
Princess Margaret Cancer Centre, Toronto, , Canada
Aalborg University Hospital, Aalborg, , Denmark
Gentofte Hospital, Herlev, , Denmark
GSK Investigational Site, Koebenhavn, , Denmark
GSK Investigational Site, Ålborg, , Denmark
Hopital Saint-Louis, Paris, ILE-De-FRANCE, France
Centre Hospitalier Le Mans, Le Mans, Pays De La Loire, France
GSK Investigational Site, Le Mans Cedex, , France
CHRU Huriez Lille, Lille Cedex, , France
GSK Investigational Site, Marseille CEDEX 9, , France
Institut Paoli Calmettes, Marseille, , France
GSK Investigational Site, Paris cedex 10, , France
GSK Investigational Site, Pessac cedex, , France
Hôpital Haut-Lévêque, Pessac Cedex, , France
Centre Hospitalier Lyon Sud, Pierre Bénite Cedex, , France
GSK Investigational Site, Pierre-Bénite cedex, , France
GSK Investigational Site, Toulouse Cedex 9, , France
Institut Universitaire du Cancer, Toulouse Cedex 9, , France
GSK Investigational Site, Freiburg, Baden-Wuerttemberg, Germany
GSK Investigational Site, Aachen, Nordrhein-Westfalen, Germany
Universitätsklinikum Aachen, Aachen, Nordrhein-Westfalen, Germany
GSK Investigational Site, Koeln, Nordrhein-Westfalen, Germany
GSK Investigational Site, Mainz, Rheinland-Pfalz, Germany
GSK Investigational Site, Halle, Sachsen-Anhalt, Germany
Universitätsklinikum Halle, Halle, Sachsen-Anhalt, Germany
GSK Investigational Site, Dresden, Sachsen, Germany
GSK Investigational Site, Leipzig, Sachsen, 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, Gyor-Moson-Sopron, Hungary
Szent Borbála Kórház, Tatabánya, Komárom-Esztergom, Hungary
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Budapest, Pest, 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, Nyiregyhaza, , 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), Basilicata, Italy
GSK Investigational Site, Napoli, Campania, Italy
GSK Investigational Site, Bologna, Emilia-Romagna, Italy
Azienda Ospedaliero - Universitaria Careggi, Firenze, Florence, Italy
GSK Investigational Site, Genova, Liguria, Italy
GSK Investigational Site, Milano, Lombardia, Italy
GSK Investigational Site, Monza (MB), Lombardia, 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, Torino, Piemonte, Italy
GSK Investigational Site, Firenze, Toscana, 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, 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, Milano, , Italy
Azienda Ospedaliera Universitaria Federico II, Napoli, , 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
Inje University Haeundae Paik Hospital, Busan, Busan Gwang'yeogsi [Pusan-Kwangyokshi], Korea, Republic of
Kyungpook National University Hospital, Daegu, Daegu Gwang'yeogsi, Korea, Republic of
Severance Hospital, Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], Korea, Republic of
GSK Investigational Site, Busan, , Korea, Republic of
GSK Investigational Site, Daegu, , Korea, Republic of
GSK Investigational Site, Seoul, , Korea, Republic of
GSK Investigational Site, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Catholic University of Korea Seoul Saint Mary's Hospital, Seoul, , Korea, Republic of
GSK Investigational Site, Seoul, , Korea, Republic of
GSK Investigational Site, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Maastricht University Medical Centre, Maastricht, Limburg, Netherlands
GSK Investigational Site, Maastricht, , Netherlands
Szpital Wojewódzki w Opolu, Opole, Opolskie, Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza, Brzozów, Podkarpacki, Poland
Uniwersyteckie Centrum Kliniczne, Gdańsk, Pomoskie, Poland
GSK Investigational Site, Brzozow, , Poland
GSK Investigational Site, Chorzow, , 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, Poznań, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA w Poznaniu im. Ledwika Bierkowskiego, Poznań, , Poland
GSK Investigational Site, Brasov, , Romania
Policlinica de Diagnostic Rapid SA, Braşov, , Romania
GSK Investigational Site, Bucharest, , Romania
GSK Investigational Site, Bucharest, , Romania
Spitalul Clinic Coltea, Bucuresti, , Romania
Institutul Clinic Fundeni, Bucuresti, , 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, Iasi, , Romania
Institutul Regional De Oncologie IASI, Iasi, , Romania
GSK Investigational Site, Singapore, , Singapore
Singapore General Hospital, Singapore, , Singapore
GSK Investigational Site, Singapore, , Singapore
Raffles Hospital, Singapore, , Singapore
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, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
GSK Investigational Site, Kaohsiung, , Taiwan
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, , Taiwan
GSK Investigational Site, Taipei, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital - Linkou Branch, Taoyuan, , Taiwan
GSK Investigational Site, Taoyuan, , 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
Contact Details
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR
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