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Spots Global Cancer Trial Database for Controlled Myelofibrosis Study With Oral Janus-associated Kinase (JAK) Inhibitor Treatment-II: The COMFORT-II Trial

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Trial Identification

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

Conditions

Myelofibrosis

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Novartis Pharmaceuticals

Affiliation: Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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