Melanoma Clinical Trial
A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma
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.
Eligibility Criteria
Inclusion Criteria:
Adults at least 18 years of age
Has advanced (unresectable Stage III) or metastatic (Stage IV) melanoma that is BRAF mutation positive (V600E)
Is treatment naive for advanced (unresectable) or metastatic melanoma, with the exception of Interleukin 2 (IL-2) which is allowed.
Has measurable disease according to RECIST 1.1 criteria.
Women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study treatment.
Women with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 4 weeks after the last dose of study medication.
Men with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 16 weeks after the last dose of study medication.
Must have adequate organ function.
Must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
Exclusion Criteria:
Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy or surgery).
Evidence of active central nervous system (CNS) disease.
Previous treatment for metastatic melanoma, including treatment with BRAF or MEK inhibitor.
A history of other malignancy. Subjects who have been disease-free for 5 years or subjects with a history of complete resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
History of Human Immunodeficiency Virus (HIV) infection.
Certain cardiac abnormalities
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There are 93 Locations for this study
Birmingham Alabama, 35243, United States
Mobile Alabama, 36608, United States
La Jolla California, 92093, United States
Los Angeles California, 90095, United States
San Francisco California, 94115, United States
Vallejo California, 94589, United States
Orlando Florida, 32806, United States
Indianapolis Indiana, 46202, United States
Ann Arbor Michigan, 48109, United States
Lebanon New Hampshire, 03756, United States
New York New York, 10065, United States
Westmead New South Wales, 2145, Australia
Southport Queensland, 4215, Australia
Adelaide South Australia, 5000, Australia
Nedlands Western Australia, 6009, Australia
Edmonton Alberta, T6G 1, Canada
Kelowna British Columbia, V1Y 5, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H3T 1, Canada
Bordeaux , 33075, France
Lille , 59037, France
Marseille Cedex 5 , 13385, France
Nice , 06202, France
Paris cedex 18 , 75877, France
Paris , 75006, France
Reims , 51092, France
Villejuif , 94805, France
Heidelberg Baden-Wuerttemberg, 69120, Germany
Ulm Baden-Wuerttemberg, 89081, Germany
Erlangen Bayern, 91054, Germany
Nuernberg Bayern, 90419, Germany
Regensburg Bayern, 93053, Germany
Kassel Hessen, 34125, Germany
Wiesbaden Hessen, 65191, Germany
Hannover Niedersachsen, 30449, Germany
Bonn Nordrhein-Westfalen, 53127, Germany
Essen Nordrhein-Westfalen, 45122, Germany
Koeln Nordrhein-Westfalen, 50937, Germany
Muenster Nordrhein-Westfalen, 48149, Germany
Koblenz Rheinland-Pfalz, 56068, Germany
Ludwigshafen Rheinland-Pfalz, 67063, Germany
Mainz Rheinland-Pfalz, 55131, Germany
Homburg Saarland, 66421, Germany
Magdeburg Sachsen-Anhalt, 39120, Germany
Kiel Schleswig-Holstein, 24105, Germany
Erfurt Thueringen, 99089, Germany
Gera Thueringen, 07548, Germany
Jena Thueringen, 07740, Germany
Budapest , H-112, Hungary
Debrecen , 4032, Hungary
Gyor , H-902, Hungary
Miskolc , 3526, Hungary
Pecs , 7624, Hungary
Cork , , Ireland
Dublin , 4, Ireland
Dublin , 7, Ireland
Dublin , 8, Ireland
Dublin , 9, Ireland
Galway , Co Ga, Ireland
Modena Emilia-Romagna, 41100, Italy
Udine Friuli-Venezia-Giulia, 33100, Italy
Roma Lazio, 00144, Italy
Roma Lazio, 00167, Italy
Genova Liguria, 16132, Italy
Rozzano (MI) Lombardia, 20089, Italy
Siena Toscana, 53100, Italy
Terni Umbria, 05100, Italy
Padova Veneto, 35128, Italy
Amsterdam , 1066 , Netherlands
Brzozow , 36-20, Poland
Konin , 62-50, Poland
Krakow , 31-11, Poland
Slupsk , 76-20, Poland
Warszawa , 02-78, Poland
Kazan , 42002, Russian Federation
Moscow , 11547, Russian Federation
Ryazan , 39001, Russian Federation
St. Petersburg , 19110, Russian Federation
St. Petersburg , 19775, Russian Federation
St. Petersburg , 19825, Russian Federation
Stavropol , 35504, Russian Federation
Badalona , 08916, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Hospitalet de Llobregat, Barcelona , 08907, Spain
Madrid , 28007, Spain
Madrid , 28033, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28050, Spain
Pamplona , 31008, Spain
Sevilla , 41013, Spain
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