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Extended Access of Momelotinib in Adults With Myelofibrosis
Sponsor: GlaxoSmithKline
Summary
This is an extended-access, long-term safety study for participants with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF) who have not experienced progression of disease and who have tolerated momelotinib (MMB) treatment while participating in previous MMB clinical trials (GS-US-352-0101 \[NCT01969838\], GS-US-352-1214 \[NCT02101268\], GS-US-352-1154 \[NCT02124746\] and SRA-MMB-301 \[NCT04173494\]). Participants in all cohorts continuing MMB treatment will discontinue MMB from the previous study and initiate MMB in this study at the same dose they were receiving in the previous study. Following the final data cut-off date, the study may move into the post analysis continuation of treatment (PACT) phase in which participants will continue to receive MMB and will be monitored and receive follow-up care in accordance with standard local clinical practice.
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
2028-12-29
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
Momelotinib
Momelotinib will be administered
Locations (112)
GSK Investigational Site
Scottsdale, Arizona, 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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Portland, Oregon, 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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Milan, MI, Italy
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Rionero in Vulture, PZ, Italy
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Roma, RM, Italy
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Bologna, Italy
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Florence, Italy
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Genova, Italy
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Monza, Italy
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Naples, Italy
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Pesaro, 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
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Bucharest, Romania
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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
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Badalona, Barcelona, Spain
GSK Investigational Site
Majadahonda, Madrid, Spain
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
Madrid, Spain