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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
2026-12-11
Last Updated
2026-04-20
Healthy Volunteers
No
Conditions
Interventions
MMB
Tablet(s) administered orally once daily
Locations (112)
GSK Investigational Site
Scottsdale, Arizona, United States
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Orange, California, United States
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Stanford, California, United States
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Aurora, Colorado, United States
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Jacksonville, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Hackensack, New Jersey, United States
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The Bronx, New York, United States
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Cleveland, Ohio, United States
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South Brisbane, Queensland, Australia
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Bedford Park, South Australia, Australia
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Frankston, Victoria, Australia
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Melbourne, Victoria, Australia
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Melbourne, Victoria, Australia
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Perth, Western Australia, Australia
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Linz, Austria
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Vienna, Austria
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Antwerp, Belgium
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Bruges, Belgium
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Leuven, Belgium
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Liège, Belgium
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Pleven, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Aalborg, Denmark
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Herlev, Denmark
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Le Mans, France
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Lille, France
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Marseille, France
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Paris, France
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Pessac, France
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Pierre-Bénite, France
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Toulouse, France
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Aachen, Germany
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Cologne, Germany
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Dresden, Germany
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Halle, Germany
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Leipzig, Germany
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Lübeck, Germany
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Mainz, Germany
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Budapest, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Győr, Hungary
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Kaposvár, Hungary
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Nyíregyháza, Hungary
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Tatabánya, Hungary
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Afula, Israel
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Ashkelon, Israel
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Haifa, Israel
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Jerusalem, Israel
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Kfar Saba, Israel
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Bologna, Italy
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Florence, Italy
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Genova, Italy
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Milan, Italy
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Monza, Italy
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Naples, Italy
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Pesaro, Italy
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Rionero in Vulture PZ, Italy
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Roma, Italy
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Torino, Italy
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Torino, Italy
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Verona, Italy
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Maastricht, Netherlands
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Brzozów, Poland
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Chorzów, Poland
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Gdansk, Poland
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Krakow, Poland
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Lublin, Poland
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Opole, Poland
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Poznan, Poland
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Brasov, Romania
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Bucharest, Romania
GSK Investigational Site
Bucharest, Romania
GSK Investigational Site
Cluj-Napoca, Romania
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Craiova, Romania
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Iași, Romania
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Singapore, Singapore
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Singapore, Singapore
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Busan, South Korea
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Daegu, South Korea
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Seoul, South Korea
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Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
Pamplona, Spain
GSK Investigational Site
Zaragoza, Spain
GSK Investigational Site
Kaohsiung City, Taiwan
GSK Investigational Site
Kaohsiung City, Taiwan
GSK Investigational Site
Taipei, Taiwan
GSK Investigational Site
Taoyuan District, Taiwan
GSK Investigational Site
Airdrie, United Kingdom
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Bristol, United Kingdom
GSK Investigational Site
Cardiff, United Kingdom
GSK Investigational Site
London, United Kingdom
GSK Investigational Site
Oxford, United Kingdom