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Brief Title: GSK1120212 vs Chemotherapy in Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma
Official Title: A Phase III Randomized, Open-label Study Comparing GSK1120212 to Chemotherapy in Subjects With Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma
Study ID: NCT01245062
Brief Summary: This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212 to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV malignant cutaneous melanoma. All subjects must have a BRAF mutation-positive tumour sample. Subjects who have received up to one prior regimen of chemotherapy in the advanced or metastatic melanoma setting will be enrolled into the study. Subjects with any prior BRAF or MEK inhibitor use will be excluded. Approximately 297 subjects will be enrolled with 2:1 randomization (198 subjects into the GSK1120212 arm and 99 subjects into the chemotherapy arm). The primary endpoint for the statistical analysis will be a comparison of progression free survival for subjects receiving GSK1120212 compared to chemotherapy. Subjects who have progression on chemotherapy will be offered the option to receive GSK1120212.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
GSK Investigational Site, Tucson, Arizona, United States
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GSK Investigational Site, Ciudad Autonoma de Buenos Aires, , Argentina
GSK Investigational Site, Garran, Australian Capital Territory, Australia
GSK Investigational Site, Port Macquarie, New South Wales, Australia
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GSK Investigational Site, Kurralta Park, South Australia, Australia
GSK Investigational Site, Woodville, South Australia, Australia
GSK Investigational Site, Heidelberg, Victoria, Australia
GSK Investigational Site, Melbourne, Victoria, Australia
GSK Investigational Site, Graz, , Austria
GSK Investigational Site, Wien, , Austria
GSK Investigational Site, Brussels, , Belgium
GSK Investigational Site, Charleroi, , Belgium
GSK Investigational Site, Gent, , Belgium
GSK Investigational Site, Jette, , Belgium
GSK Investigational Site, Kortrijk, , Belgium
GSK Investigational Site, Leuven, , Belgium
GSK Investigational Site, Wilrijk, , Belgium
GSK Investigational Site, Yvoir, , Belgium
GSK Investigational Site, Calgary, Alberta, Canada
GSK Investigational Site, Vancouver, British Columbia, Canada
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GSK Investigational Site, Ottawa, Ontario, Canada
GSK Investigational Site, Toronto, Ontario, Canada
GSK Investigational Site, Montreal, Quebec, Canada
GSK Investigational Site, Montreal, Quebec, Canada
GSK Investigational Site, Hradec Kralove, , Czechia
GSK Investigational Site, Ostrava, , Czechia
GSK Investigational Site, Praha 2, , Czechia
GSK Investigational Site, Zlin, , Czechia
GSK Investigational Site, Boulogne-Billancourt, , France
GSK Investigational Site, Grenoble, , France
GSK Investigational Site, Montpellier, , France
GSK Investigational Site, Nantes, , France
GSK Investigational Site, Paris Cedex 10, , France
GSK Investigational Site, Pierre-Benite cedex, , France
GSK Investigational Site, Rennes, , France
GSK Investigational Site, Tours, , France
GSK Investigational Site, Villejuif, , France
GSK Investigational Site, Heidelberg, Baden-Wuerttemberg, Germany
GSK Investigational Site, Mannheim, Baden-Wuerttemberg, Germany
GSK Investigational Site, Tuebingen, Baden-Wuerttemberg, Germany
GSK Investigational Site, Muenchen, Bayern, Germany
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GSK Investigational Site, Dresden, Sachsen, Germany
GSK Investigational Site, Luebeck, Schleswig-Holstein, Germany
GSK Investigational Site, Berlin, , Germany
GSK Investigational Site, Athens, , Greece
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GSK Investigational Site, Pisa, Toscana, Italy
GSK Investigational Site, Christchurch, , New Zealand
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GSK Investigational Site, Newtown, Wellington, , New Zealand
GSK Investigational Site, Oslo, , Norway
GSK Investigational Site, Poznan, , Poland
GSK Investigational Site, Warszawa, , Poland
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GSK Investigational Site, Chelyabinsk, , Russian Federation
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GSK Investigational Site, St. Petersburg, , Russian Federation
GSK Investigational Site, Goteborg, , Sweden
GSK Investigational Site, Linkoping, , Sweden
GSK Investigational Site, Lund, , Sweden
GSK Investigational Site, Stockholm, , Sweden
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GSK Investigational Site, Zurich, , Switzerland
GSK Investigational Site, Dnepropetrovsk, , Ukraine
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GSK Investigational Site, Cambridge, Cambridgeshire, United Kingdom
GSK Investigational Site, Northwood, Middlesex, United Kingdom
GSK Investigational Site, Sutton, Surrey, United Kingdom
GSK Investigational Site, Aberdeen, , United Kingdom
GSK Investigational Site, Birmingham, , United Kingdom
GSK Investigational Site, Chelmsford, , United Kingdom
GSK Investigational Site, Leeds, , United Kingdom
GSK Investigational Site, London, , United Kingdom
GSK Investigational Site, London, , United Kingdom
GSK Investigational Site, Manchester, , United Kingdom
GSK Investigational Site, Oxford, , United Kingdom
GSK Investigational Site, Southampton, , United Kingdom
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR