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.

View Eligibility Criteria

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

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

251

Study ID:

NCT01227889

Recruitment Status:

Completed

Sponsor:

GlaxoSmithKline

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There are 93 Locations for this study

See Locations Near You

GSK Investigational Site
Birmingham Alabama, 35243, United States
GSK Investigational Site
Mobile Alabama, 36608, United States
GSK Investigational Site
La Jolla California, 92093, United States
GSK Investigational Site
Los Angeles California, 90095, United States
GSK Investigational Site
San Francisco California, 94115, United States
GSK Investigational Site
Vallejo California, 94589, United States
GSK Investigational Site
Orlando Florida, 32806, United States
GSK Investigational Site
Indianapolis Indiana, 46202, United States
GSK Investigational Site
Ann Arbor Michigan, 48109, United States
GSK Investigational Site
Lebanon New Hampshire, 03756, United States
GSK Investigational Site
New York New York, 10065, United States
GSK Investigational Site
Westmead New South Wales, 2145, Australia
GSK Investigational Site
Southport Queensland, 4215, Australia
GSK Investigational Site
Adelaide South Australia, 5000, Australia
GSK Investigational Site
Nedlands Western Australia, 6009, Australia
GSK Investigational Site
Edmonton Alberta, T6G 1, Canada
GSK Investigational Site
Kelowna British Columbia, V1Y 5, Canada
GSK Investigational Site
Toronto Ontario, M4N 3, Canada
GSK Investigational Site
Toronto Ontario, M5G 2, Canada
GSK Investigational Site
Montreal Quebec, H3T 1, Canada
GSK Investigational Site
Bordeaux , 33075, France
GSK Investigational Site
Lille , 59037, France
GSK Investigational Site
Marseille Cedex 5 , 13385, France
GSK Investigational Site
Nice , 06202, France
GSK Investigational Site
Paris cedex 18 , 75877, France
GSK Investigational Site
Paris , 75006, France
GSK Investigational Site
Reims , 51092, France
GSK Investigational Site
Villejuif , 94805, France
GSK Investigational Site
Heidelberg Baden-Wuerttemberg, 69120, Germany
GSK Investigational Site
Ulm Baden-Wuerttemberg, 89081, Germany
GSK Investigational Site
Erlangen Bayern, 91054, Germany
GSK Investigational Site
Nuernberg Bayern, 90419, Germany
GSK Investigational Site
Regensburg Bayern, 93053, Germany
GSK Investigational Site
Kassel Hessen, 34125, Germany
GSK Investigational Site
Wiesbaden Hessen, 65191, Germany
GSK Investigational Site
Hannover Niedersachsen, 30449, Germany
GSK Investigational Site
Bonn Nordrhein-Westfalen, 53127, Germany
GSK Investigational Site
Essen Nordrhein-Westfalen, 45122, Germany
GSK Investigational Site
Koeln Nordrhein-Westfalen, 50937, Germany
GSK Investigational Site
Muenster Nordrhein-Westfalen, 48149, Germany
GSK Investigational Site
Koblenz Rheinland-Pfalz, 56068, Germany
GSK Investigational Site
Ludwigshafen Rheinland-Pfalz, 67063, Germany
GSK Investigational Site
Mainz Rheinland-Pfalz, 55131, Germany
GSK Investigational Site
Homburg Saarland, 66421, Germany
GSK Investigational Site
Magdeburg Sachsen-Anhalt, 39120, Germany
GSK Investigational Site
Kiel Schleswig-Holstein, 24105, Germany
GSK Investigational Site
Erfurt Thueringen, 99089, Germany
GSK Investigational Site
Gera Thueringen, 07548, Germany
GSK Investigational Site
Jena Thueringen, 07740, Germany
GSK Investigational Site
Budapest , H-112, Hungary
GSK Investigational Site
Debrecen , 4032, Hungary
GSK Investigational Site
Gyor , H-902, Hungary
GSK Investigational Site
Miskolc , 3526, Hungary
GSK Investigational Site
Pecs , 7624, Hungary
GSK Investigational Site
Cork , , Ireland
GSK Investigational Site
Dublin , 4, Ireland
GSK Investigational Site
Dublin , 7, Ireland
GSK Investigational Site
Dublin , 8, Ireland
GSK Investigational Site
Dublin , 9, Ireland
GSK Investigational Site
Galway , Co Ga, Ireland
GSK Investigational Site
Modena Emilia-Romagna, 41100, Italy
GSK Investigational Site
Udine Friuli-Venezia-Giulia, 33100, Italy
GSK Investigational Site
Roma Lazio, 00144, Italy
GSK Investigational Site
Roma Lazio, 00167, Italy
GSK Investigational Site
Genova Liguria, 16132, Italy
GSK Investigational Site
Rozzano (MI) Lombardia, 20089, Italy
GSK Investigational Site
Siena Toscana, 53100, Italy
GSK Investigational Site
Terni Umbria, 05100, Italy
GSK Investigational Site
Padova Veneto, 35128, Italy
GSK Investigational Site
Amsterdam , 1066 , Netherlands
GSK Investigational Site
Brzozow , 36-20, Poland
GSK Investigational Site
Konin , 62-50, Poland
GSK Investigational Site
Krakow , 31-11, Poland
GSK Investigational Site
Slupsk , 76-20, Poland
GSK Investigational Site
Warszawa , 02-78, Poland
GSK Investigational Site
Kazan , 42002, Russian Federation
GSK Investigational Site
Moscow , 11547, Russian Federation
GSK Investigational Site
Ryazan , 39001, Russian Federation
GSK Investigational Site
St. Petersburg , 19110, Russian Federation
GSK Investigational Site
St. Petersburg , 19775, Russian Federation
GSK Investigational Site
St. Petersburg , 19825, Russian Federation
GSK Investigational Site
Stavropol , 35504, Russian Federation
GSK Investigational Site
Badalona , 08916, Spain
GSK Investigational Site
Barcelona , 08035, Spain
GSK Investigational Site
Barcelona , 08036, Spain
GSK Investigational Site
Hospitalet de Llobregat, Barcelona , 08907, Spain
GSK Investigational Site
Madrid , 28007, Spain
GSK Investigational Site
Madrid , 28033, Spain
GSK Investigational Site
Madrid , 28034, Spain
GSK Investigational Site
Madrid , 28040, Spain
GSK Investigational Site
Madrid , 28041, Spain
GSK Investigational Site
Madrid , 28050, Spain
GSK Investigational Site
Pamplona , 31008, Spain
GSK Investigational Site
Sevilla , 41013, Spain

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

251

Study ID:

NCT01227889

Recruitment Status:

Completed

Sponsor:


GlaxoSmithKline

How clear is this clinincal trial information?

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