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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

Cancer

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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