Myeloproliferative Neoplasms Clinical Trial
Extended Access of Momelotinib in Adults With Myelofibrosis
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.
Eligibility Criteria
Key Inclusion Criteria:
Currently enrolled in Studies GS-US-352-0101, GS-US-352-1214, GS-US-352-1154, or SRA-MMB-301
Able to comprehend and willing to sign the informed consent form
Key Exclusion Criteria:
Known hypersensitivity to MMB, its metabolites, or formulation excipients
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
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There are 136 Locations for this study
Orange California, 92868, United States
Stanford California, 94305, United States
Stanford California, 94305, United States
Aurora Colorado, 80045, United States
Aurora Colorado, 80045, United States
Jacksonville Florida, 32224, United States
Jacksonville Florida, 32224, United States
Tampa Florida, 33612, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30322, United States
Rolling Meadows Illinois, 60008, United States
Baltimore Maryland, 21229, United States
Baltimore Maryland, 21229, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Rochester Minnesota, 55905, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63130, United States
Hackensack New Jersey, 07601, United States
Hackensack New Jersey, 07601, United States
Bronx New York, 10467, United States
Bronx New York, 10467, United States
Cleveland Ohio, 44195, United States
Cleveland Ohio, 44195, United States
Portland Oregon, 97239, United States
Milwaukee Wisconsin, 53226, United States
Milwaukee Wisconsin, 53226, United States
Hyde Park Queensland, 4812, Australia
South Brisbane Queensland, 4101, Australia
Adelaide South Australia, 5000, Australia
Adelaide South Australia, 5000, Australia
Frankston Victoria, 31 99, Australia
Frankston Victoria, 3199, Australia
Melbourne Victoria, 3004, Australia
Melbourne Victoria, 3004, Australia
Parkville Victoria, 3050, Australia
Parkville Victoria, 3050, Australia
Perth Western Australia, 6000, Australia
Perth Western Australia, 6160, Australia
Linz Upper Austria, 4020, Austria
Wien Vienna, 1090, Austria
Linz , 4020, Austria
Wien , 1090, Austria
Brugge West-Vlaanderen, 8000, Belgium
Antwerpen , 2060, Belgium
Antwerp , 2060, Belgium
Brugge , 8000, Belgium
Leuven , 3000, Belgium
Leuven , 3000, Belgium
Liège , 4000, Belgium
Liège , 4000, Belgium
Pleven , 5800, Bulgaria
Pleven , 5800, Bulgaria
Ruse , 7002, Bulgaria
Ruse , 7002, Bulgaria
Sofia , 01431, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1756, Bulgaria
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H3H 2, Canada
Montreal Quebec, H3T 1, Canada
Montréal Quebec, H3H 2, Canada
Montréal , H3T 1, Canada
Toronto , M5G 2, Canada
Aalborg , 9000, Denmark
Herlev , 2730, Denmark
Koebenhavn , 2100, Denmark
Ã…lborg , 9000, Denmark
Paris ILE-De-FRANCE, 75475, France
Le Mans Pays De La Loire, 72037, France
Le Mans Cedex , 72037, France
Lille Cedex , 59020, France
Marseille CEDEX 9 , 13273, France
Marseille , 13273, France
Paris cedex 10 , 75475, France
Pessac cedex , 33604, France
Pessac Cedex , 33604, France
Pierre Bénite Cedex , 69495, France
Pierre-Bénite cedex , 69495, France
Toulouse Cedex 9 , 31059, France
Toulouse Cedex 9 , 31059, France
Freiburg Baden-Wuerttemberg, 79106, Germany
Aachen Nordrhein-Westfalen, 52074, Germany
Aachen Nordrhein-Westfalen, 52074, Germany
Koeln Nordrhein-Westfalen, 50937, Germany
Mainz Rheinland-Pfalz, 55131, Germany
Halle Sachsen-Anhalt, 06120, Germany
Halle Sachsen-Anhalt, 06120, Germany
Dresden Sachsen, 01307, Germany
Leipzig Sachsen, 04103, Germany
Lübeck Schleswig-Holstein, 23538, Germany
Cologne , 50937, Germany
Dresden , 01307, Germany
Leipzig , 04103, Germany
Mainz , 55131, Germany
Győr Gyor-Moson-Sopron, 9023, Hungary
Tatabánya Komárom-Esztergom, 2800, Hungary
Budapest Pest, 1097, Hungary
NyÃregyháza Szabolcs-Szatmár-Bereg, 4400, Hungary
Budapest , 1083, Hungary
Budapest , 1083, Hungary
Budapest , 1097, Hungary
Debrecen , 4032, Hungary
Debrecen , 4032, Hungary
Győr , 9024, Hungary
Kaposvár , 7400, Hungary
Kaposvár , 7400, Hungary
Nyiregyhaza , 4400, Hungary
Tatabánya , 2800, Hungary
Afula , 18101, Israel
Afula , 18341, Israel
Ashkelon , 78278, Israel
Ashkelton , 78306, Israel
Haifa , 34362, Israel
Haifa , 34362, Israel
Jerusalem , 91120, Israel
Jerusalem , 91120, Israel
Kfar Saba , 44281, Israel
Kfar Saba , 44281, Israel
Rionero In Vulture (Pz) Basilicata, 85028, Italy
Napoli Campania, 80131, Italy
Bologna Emilia-Romagna, 40138, Italy
Firenze Florence, 50134, Italy
Genova Liguria, 16132, Italy
Milano Lombardia, 20122, Italy
Monza (MB) Lombardia, 20900, Italy
Monza Monza E Brianza, 20900, Italy
Pesaro Pesaro E Urbino, 61121, Italy
Torino Piemonte, 10126, Italy
Firenze Toscana, 50134, Italy
Torino Trentino-Alto Adige, 10128, Italy
Torino Turin, 10126, Italy
Torino Turin, 10128, Italy
Verona Veneto, 37134, Italy
Bologna , 40138, Italy
Genova , 16132, Italy
Milano , 20122, Italy
Napoli , 80131, Italy
Pesaro , 61122, Italy
Potenza , 85028, Italy
Roma , 00161, Italy
Roma , 00161, Italy
Verona , 37134, Italy
Busan Busan Gwang'yeogsi [Pusan-Kwangyokshi], 48108, Korea, Republic of
Daegu Daegu Gwang'yeogsi, 41944, Korea, Republic of
Seoul Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 03722, Korea, Republic of
Busan , 48108, Korea, Republic of
Daegu , 700-7, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Seoul , 137-7, Korea, Republic of
Seoul , 3080, Korea, Republic of
Maastricht Limburg, 6229 , Netherlands
Maastricht , 6229 , Netherlands
Opole Opolskie, 45-06, Poland
Brzozów Podkarpacki, 36-20, Poland
Gdańsk Pomoskie, 80-95, Poland
Brzozow , 36-20, Poland
Chorzow , 41-50, Poland
Chorzów , 41-50, Poland
Gdansk , 80-21, Poland
Krakow , 31-50, Poland
Lublin , 20-08, Poland
Lublin , 20-08, Poland
Małogoskie , 31-50, Poland
Opole , 45-06, Poland
Poznań , 60-63, Poland
Poznań , 60-63, Poland
Brasov , 50015, Romania
BraÅŸov , 50015, Romania
Bucharest , 02232, Romania
Bucharest , 03017, Romania
Bucuresti , 03017, Romania
Bucuresti , 22328, Romania
Cluj-Napoca , 40012, Romania
Cluj-Napoca , 40012, Romania
Craiova , 20014, Romania
Craiova , 20014, Romania
Iasi , 70011, Romania
Iasi , 70048, Romania
Singapore , 16960, Singapore
Singapore , 16960, Singapore
Singapore , 18877, Singapore
Singapore , 18877, Singapore
Badalona Barcelona, 08916, Spain
Barcelona , 08003, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Barcelona , 08916, Spain
Barcelona , 8035, Spain
Madrid , 28034, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Madrid , 28041, Spain
Madrid , 28222, Spain
Majadahonda (Madrid) , 28222, Spain
Pamplona , 31008, Spain
Pamplona , 31008, Spain
Zaragoza , 50009, Spain
Zaragoza , 50012, Spain
Kaohsiung , 807, Taiwan
Kaohsiung , 807, Taiwan
Kaohsiung , 833, Taiwan
Kaohsiung , 88301, Taiwan
Taipei , 100, Taiwan
Taipei , 100, Taiwan
Taoyuan , 333, Taiwan
Taoyuan , 333, Taiwan
Bristol England, BS2 8, United Kingdom
Airdrie Lanarkshire, ML6 0, United Kingdom
Airdrie Scotland, ML6 0, United Kingdom
Bristol , BS2 8, United Kingdom
Cardiff , CF14 , United Kingdom
Cardiff , CF14 , United Kingdom
London , W12 0, United Kingdom
London , W12 O, United Kingdom
Oxford. , OX3 7, United Kingdom
Oxford , OX3 7, United Kingdom
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