Spots Global Cancer Trial Database for A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma
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Trial Identification
Brief Title: A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma
Official Title: A Phase III Randomized, Open-label Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma
Study ID: NCT01227889
Conditions
Study Description
Brief Summary: BRF113683 is a Phase III, randomized, open-label study comparing the efficacy, safety, and tolerability of GSK2118436 to dacarbazine (DTIC), in subjects with BRAF mutant advanced (Stage III) or metastatic (Stage IV) melanoma. Subjects will be randomized to receive 150 mg of GSK2118436 twice daily or 1000 mg/m2 DTIC every 3 weeks and continue on treatment until disease progression, death, or unacceptable adverse event. Subjects who progress on DTIC will be allowed to crossover to an optional extension arm of the study to receive GSK2118436.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
GSK Investigational Site, Birmingham, Alabama, United States
GSK Investigational Site, Mobile, Alabama, United States
GSK Investigational Site, La Jolla, California, United States
GSK Investigational Site, Los Angeles, California, United States
GSK Investigational Site, San Francisco, California, United States
GSK Investigational Site, Vallejo, California, United States
GSK Investigational Site, Orlando, Florida, United States
GSK Investigational Site, Indianapolis, Indiana, United States
GSK Investigational Site, Ann Arbor, Michigan, United States
GSK Investigational Site, Lebanon, New Hampshire, United States
GSK Investigational Site, New York, New York, United States
GSK Investigational Site, Westmead, New South Wales, Australia
GSK Investigational Site, Southport, Queensland, Australia
GSK Investigational Site, Adelaide, South Australia, Australia
GSK Investigational Site, Nedlands, Western Australia, Australia
GSK Investigational Site, Edmonton, Alberta, Canada
GSK Investigational Site, Kelowna, British Columbia, Canada
GSK Investigational Site, Toronto, Ontario, Canada
GSK Investigational Site, Toronto, Ontario, Canada
GSK Investigational Site, Montreal, Quebec, Canada
GSK Investigational Site, Bordeaux, , France
GSK Investigational Site, Lille, , France
GSK Investigational Site, Marseille Cedex 5, , France
GSK Investigational Site, Nice, , France
GSK Investigational Site, Paris cedex 18, , France
GSK Investigational Site, Paris, , France
GSK Investigational Site, Reims, , France
GSK Investigational Site, Villejuif, , France
GSK Investigational Site, Heidelberg, Baden-Wuerttemberg, Germany
GSK Investigational Site, Ulm, Baden-Wuerttemberg, Germany
GSK Investigational Site, Erlangen, Bayern, Germany
GSK Investigational Site, Nuernberg, Bayern, Germany
GSK Investigational Site, Regensburg, Bayern, Germany
GSK Investigational Site, Kassel, Hessen, Germany
GSK Investigational Site, Wiesbaden, Hessen, Germany
GSK Investigational Site, Hannover, Niedersachsen, Germany
GSK Investigational Site, Bonn, Nordrhein-Westfalen, Germany
GSK Investigational Site, Essen, Nordrhein-Westfalen, Germany
GSK Investigational Site, Koeln, Nordrhein-Westfalen, Germany
GSK Investigational Site, Muenster, Nordrhein-Westfalen, Germany
GSK Investigational Site, Koblenz, Rheinland-Pfalz, Germany
GSK Investigational Site, Ludwigshafen, Rheinland-Pfalz, Germany
GSK Investigational Site, Mainz, Rheinland-Pfalz, Germany
GSK Investigational Site, Homburg, Saarland, Germany
GSK Investigational Site, Magdeburg, Sachsen-Anhalt, Germany
GSK Investigational Site, Kiel, Schleswig-Holstein, Germany
GSK Investigational Site, Erfurt, Thueringen, Germany
GSK Investigational Site, Gera, Thueringen, Germany
GSK Investigational Site, Jena, Thueringen, Germany
GSK Investigational Site, Budapest, , Hungary
GSK Investigational Site, Debrecen, , Hungary
GSK Investigational Site, Gyor, , Hungary
GSK Investigational Site, Miskolc, , Hungary
GSK Investigational Site, Pecs, , Hungary
GSK Investigational Site, Cork, , Ireland
GSK Investigational Site, Dublin, , Ireland
GSK Investigational Site, Dublin, , Ireland
GSK Investigational Site, Dublin, , Ireland
GSK Investigational Site, Dublin, , Ireland
GSK Investigational Site, Galway, , Ireland
GSK Investigational Site, Modena, Emilia-Romagna, Italy
GSK Investigational Site, Udine, Friuli-Venezia-Giulia, Italy
GSK Investigational Site, Roma, Lazio, Italy
GSK Investigational Site, Roma, Lazio, Italy
GSK Investigational Site, Genova, Liguria, Italy
GSK Investigational Site, Rozzano (MI), Lombardia, Italy
GSK Investigational Site, Siena, Toscana, Italy
GSK Investigational Site, Terni, Umbria, Italy
GSK Investigational Site, Padova, Veneto, Italy
GSK Investigational Site, Amsterdam, , Netherlands
GSK Investigational Site, Brzozow, , Poland
GSK Investigational Site, Konin, , Poland
GSK Investigational Site, Krakow, , Poland
GSK Investigational Site, Slupsk, , Poland
GSK Investigational Site, Warszawa, , Poland
GSK Investigational Site, Kazan, , Russian Federation
GSK Investigational Site, Moscow, , Russian Federation
GSK Investigational Site, Ryazan, , Russian Federation
GSK Investigational Site, St. Petersburg, , Russian Federation
GSK Investigational Site, St. Petersburg, , Russian Federation
GSK Investigational Site, St. Petersburg, , Russian Federation
GSK Investigational Site, Stavropol, , Russian Federation
GSK Investigational Site, Badalona, , Spain
GSK Investigational Site, Barcelona, , Spain
GSK Investigational Site, Barcelona, , Spain
GSK Investigational Site, Hospitalet de Llobregat, Barcelona, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Pamplona, , Spain
GSK Investigational Site, Sevilla, , Spain
Contact Details
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR
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