Spots Global Cancer Trial Database for Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain
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Trial Identification
Brief Title: Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain
Official Title: BRF117277: A Phase II, Open-Label, Multicentre Study of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain
Study ID: NCT02039947
Conditions
Study Description
Brief Summary: This is a multi-cohort, open label, Phase II study with Dabrafenib (GSK2118436) and Trametinib (GSK1120212) combination therapy in subject with BRAF mutation-positive melanoma that has metastasized to the brain. This study will evaluate the safety and efficacy of 4 cohorts. Cohorts will consist of; V600 E, D, K, R mutations, metastases to the brain, symptomatic and asymptomatic, with or without prior local (brain) therapy, with or without prior local (brain) therapy, and range of ECOG scores from 0-2.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Novartis Investigative Site, Birmingham, Alabama, United States
Novartis Investigative Site, San Francisco, California, United States
Novartis Investigative Site, Aurora, Colorado, United States
Novartis Investigative Site, Atlanta, Georgia, United States
Novartis Investigative Site, Atlanta, Georgia, United States
Novartis Investigative Site, Boston, Massachusetts, United States
Novartis Investigative Site, Chapel Hill, North Carolina, United States
Novartis Investigative Site, Columbus, Ohio, United States
Novartis Investigative Site, Pittsburgh, Pennsylvania, United States
Novartis Investigative Site, Nashville, Tennessee, United States
Novartis Investigative Site, Houston, Texas, United States
Novartis Investigative Site, North Sydney, New South Wales, Australia
Novartis Investigative Site, Greenslopes, Queensland, Australia
Novartis Investigative Site, Melbourne, Victoria, Australia
Novartis Investigative Site, Edmonton, Alberta, Canada
Novartis Investigative Site, Hamilton, Ontario, Canada
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Boulogne-Billancourt, , France
Novartis Investigative Site, Lille, , France
Novartis Investigative Site, Marseille Cedex 5, , France
Novartis Investigative Site, Montpellier cedex 5, , France
Novartis Investigative Site, Nantes Cedex 1, , France
Novartis Investigative Site, Paris Cedex 10, , France
Novartis Investigative Site, Pierre-Benite cedex, , France
Novartis Investigative Site, Poitiers, , France
Novartis Investigative Site, Rennes Cedex, , France
Novartis Investigative Site, Toulouse cedex, , France
Novartis Investigative Site, Villejuif cedex, , France
Novartis Investigative Site, Heidelberg, Baden-Wuerttemberg, Germany
Novartis Investigative Site, Tuebingen, Baden-Wuerttemberg, Germany
Novartis Investigative Site, Muenchen, Bayern, Germany
Novartis Investigative Site, Hannover, Niedersachsen, Germany
Novartis Investigative Site, Koeln, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Kiel, Schleswig-Holstein, Germany
Novartis Investigative Site, Gera, Thueringen, Germany
Novartis Investigative Site, Milano, Lombardia, Italy
Novartis Investigative Site, Milano, Lombardia, Italy
Novartis Investigative Site, Padova, Veneto, Italy
Novartis Investigative Site, Barcelona, , Spain
Novartis Investigative Site, Las Palmas De Gran Canaria, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Malaga, , Spain
Novartis Investigative Site, Palma de Mallorca, , Spain
Novartis Investigative Site, Pamplona, , Spain
Novartis Investigative Site, Valencia, , Spain
Novartis Investigative Site, Zaragoza, , Spain
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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