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Brief Title: Controlled Myelofibrosis Study With Oral Janus-associated Kinase (JAK) Inhibitor Treatment-II: The COMFORT-II Trial
Official Title: A Randomized Study of Ruxolitinib Tablets Compared to Best Available Therapy in Subjects With Primary Myelofibrosis, Post-Polycythemia Vera-Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis
Study ID: NCT00934544
Brief Summary: This was an open label, randomized study comparing the efficacy and safety of randomized 2:1 Ruxolitinib tablets versus best-available therapy, as selected by the investigator. The purpose was to compare the efficacy, safety and tolerability of Ruxolitinib (INC424/INCB018424) given twice daily to the best-available therapy, in subjects with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV-MF) or post essential thrombocythemia myelofibrosis (PET-MF).
Detailed Description: This study included a randomized treatment phase, followed by an extension phase. The treatment phase lasted from Study Day 1 (day of randomization) to the occurrence of a protocol-specified progressive disease event or study conclusion, whichever came first. The extension phase (including crossover of control group patients) lasted from the progressive disease event until the earliest of the following events: a) the patient was no longer receiving clinical benefit, b) the patient chose to withdraw from the study, or c) the study ended. All patients received ruxolitinib in the extension phase of the study. Maximum individual patient duration was 5 years.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Novartis Investigative Site, Innsbruck, , Austria
Novartis Investigative Site, Linz, , Austria
Novartis Investigative Site, Salzburg, , Austria
Novartis Investigative Site, Vienna, , Austria
Novartis Investigative Site, Antwerp, , Belgium
Novartis Investigative Site, Antwerp, , Belgium
Novartis Investigative Site, Brugge, , Belgium
Novartis Investigative Site, Brussel, , Belgium
Novartis Investigative Site, Hasselt, , Belgium
Novartis Investigative Site, Kortrijk, , Belgium
Novartis Investigative Site, La Louvière, , Belgium
Novartis Investigative Site, Leuven, , Belgium
Novartis Investigative Site, Roeselare, , Belgium
Novartis Investigative Site, Yvoir, , Belgium
Novartis Investigative Site, Amiens cedex 1, , France
Novartis Investigative Site, Caen Cedex, , France
Novartis Investigative Site, Grenoble, , France
Novartis Investigative Site, Lens Cedex, , France
Novartis Investigative Site, Lille, , France
Novartis Investigative Site, Lyon, , France
Novartis Investigative Site, Marseille, , France
Novartis Investigative Site, Nimes, , France
Novartis Investigative Site, Paris, , France
Novartis Investigative Site, Paris, , France
Novartis Investigative Site, Paris, , France
Novartis Investigative Site, Pessac, , France
Novartis Investigative Site, Poitiers Cedex, , France
Novartis Investigative Site, Rennes, , France
Novartis Investigative Site, Strasbourg, , France
Novartis Investigative Site, Toulouse Cedex, , France
Novartis Investigative Site, Villejuif Cedex, , France
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Frankfurt/M, , Germany
Novartis Investigative Site, Köln, , Germany
Novartis Investigative Site, Magdeburg, , Germany
Novartis Investigative Site, Mainz, , Germany
Novartis Investigative Site, Muenster, , Germany
Novartis Investigative Site, Stuttgart, , Germany
Novartis Investigative Site, Tuebingen, , Germany
Novartis Investigative Site, Ulm, , Germany
Novartis Investigative Site, Pavia, (pv), Italy
Novartis Investigative Site, Monza, MB, Italy
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Florence, , Italy
Novartis Investigative Site, Orbassano, , Italy
Novartis Investigative Site, Pavia, , Italy
Novartis Investigative Site, Amsterdam, , Netherlands
Novartis Investigative Site, Den Haag, , Netherlands
Novartis Investigative Site, Groningen, , Netherlands
Novartis Investigative Site, Maastricht, , Netherlands
Novartis Investigative Site, Nijmegen, , Netherlands
Novartis Investigative Site, Rotterdam, , Netherlands
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain
Novartis Investigative Site, Majadahonda, Madrid, Spain
Novartis Investigative Site, Göteborg, , Sweden
Novartis Investigative Site, Stockholm, , Sweden
Novartis Investigative Site, Belfast, , United Kingdom
Novartis Investigative Site, Cambridge, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, Oxford, , United Kingdom
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR