Spots Global Cancer Trial Database for Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis
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Trial Identification
Brief Title: Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis
Official Title: A Phase 3, Randomized, Double-blind Active-controlled Study Evaluating Momelotinib vs. Ruxolitinib in Subjects With Primary Myelofibrosis (PMF) or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)
Study ID: NCT01969838
Study Description
Brief Summary: This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib (RUX) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (post-PV/ET MF) who have not yet received treatment with a Janus kinase inhibitor (JAK inhibitor). Participants will be randomized to receive either MMB or ruxolitinib for 24 weeks during a double-blind treatment phase, after which they will be eligible to receive open-label MMB for up to an additional 216 weeks. After discontinuation of study medication, assessments will continue for 12 additional weeks, after which participants will be contacted for survival follow-up approximately every 6 months for up to 5 years from the date of enrollment or until study termination. For those participants planning to continue treatment with MMB following the end of the study, the Early Study Drug Discontinuation (ESDD), 30-day, 12-Week, and survival follow-up visits are not required.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Phoenix, Arizona, United States
, Escondido, California, United States
, Stanford, California, United States
, Jacksonville, Florida, United States
, Atlanta, Georgia, United States
, Chicago, Illinois, United States
, Baltimore, Maryland, United States
, Boston, Massachusetts, United States
, Saint Louis, Missouri, United States
, Durham, North Carolina, United States
, Seattle, Washington, United States
, Darlinghurst, New South Wales, Australia
, Parkville, New South Wales, Australia
, Saint Leonards, New South Wales, Australia
, Brisbane, Queensland, Australia
, Herston, Queensland, Australia
, Adelaide, South Australia, Australia
, Bedford Park, South Australia, Australia
, Frankston, Victoria, Australia
, Melbourne, Victoria, Australia
, Perth, Western Australia, Australia
, Wien, Vienna, Austria
, Charleroi, Hainaut, Belgium
, Antwerp, , Belgium
, Leuven, , Belgium
, Liege, , Belgium
, Pleven, , Bulgaria
, Plovdiv, , Bulgaria
, Ruse, , Bulgaria
, Sofia, , Bulgaria
, Varna, , Bulgaria
, Edmonton, Alberta, Canada
, Vancouver, British Columbia, Canada
, Hamilton, Ontario, Canada
, Toronto, Ontario, Canada
, Hradec Kralove, Vychodocesky KRAJ, Czechia
, Brno, , Czechia
, Ostrava, , Czechia
, Aalborg, , Denmark
, Herlev, , Denmark
, Toulouse cedex 9, Midi-pyrenees, France
, Pierre Bénite Cedex, Rhone-alpes, France
, Le Kremlin Bicetre Cedex, , France
, Lens, , France
, Lille Cedex, , France
, Marseille Cedex 9, , France
, Nantes cedex 1, , France
, Paris, , France
, Pessac Cedex, , France
, Villejuif Cedex, , France
, München, Bayern, Germany
, Leipzig, Sachsen, Germany
, Dresden, , Germany
, Dusseldorf, , Germany
, Freiburg, , Germany
, Hamburg, , Germany
, Mainz, , Germany
, Mannheim, , Germany
, Budapest, , Hungary
, Debrecen, , Hungary
, Kaposvár, , Hungary
, Afula, , Israel
, Ashkelon, , Israel
, Haifa, , Israel
, Jerusalem, , Israel
, Tel Aviv, , Israel
, Ogaki City, Gifu, Japan
, Kitaku Sapporo, Hokkaido, Japan
, Osaka Sayama, Osaka, Japan
, Osaka-City, Osaka, Japan
, Bunkyo-ku, Tokyo, , Japan
, Fukushima City, , Japan
, Kumamoto City, , Japan
, Matsuyama, , Japan
, Okayama, , Japan
, Seoul, , Korea, Republic of
, Maastricht, , Netherlands
, Nijmegen, , Netherlands
, Rotterdam, , Netherlands
, Utrecht, , Netherlands
, Lodz, Lodzkie, Poland
, Lublin, Lubelskie, Poland
, Kraków, Malopolskie, Poland
, Warszawa, Mazowiekie, Poland
, Gdansk, Pomorskie, Poland
, Poznan, Wielkopolskie, Poland
, Bialystok, , Poland
, Brzozow, , Poland
, Chorzow, , Poland
, Arad, , Romania
, Brasov, , Romania
, Bucuresti, , Romania
, Cluj-Napoca, , Romania
, Iasi, , Romania
, Singapore, , Singapore
, Majadahonda, Madrid, Spain
, Pamplona, Navarra, Spain
, Badalona, , Spain
, Barcelona, , Spain
, Valencia, , Spain
, Zaragoza, , Spain
, Lund, Skane, Sweden
, Stockholm, , Sweden
, Uddevalla, , Sweden
, Örebro, , Sweden
, Kaohsiung, , Taiwan
, Leicester, England, United Kingdom
, London, England, United Kingdom
, Manchester, England, United Kingdom
, Newcastle Upon Tyne, England, United Kingdom
, Oxford, England, United Kingdom
, Cardiff, Wales, United Kingdom
, Northern Ireland, , United Kingdom
, Nottingham, , United Kingdom
Contact Details
Name: Gilead Study Director
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR
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