Spots Global Cancer Trial Database for A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3)
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Trial Identification
Brief Title: A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3)
Official Title: BRIM 3: A Randomized, Open-Label, Controlled, Multicenter, Phase III Study in Previously Untreated Patients With Unresectable Stage IIIC or Stage IV Melanoma With V600E BRAF Mutation Receiving Vemurafenib (RO5185426) or Dacarbazine
Study ID: NCT01006980
Conditions
Study Description
Brief Summary: This randomized, open-label study evaluated the efficacy, safety and tolerability of vemurafenib (RO5185426) as compared to dacarbazine in previously untreated patients with metastatic melanoma. Patients were randomized to receive either vemurafenib 960 mg orally twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks. Study treatment was continued until disease progression or unacceptable toxicity occurred. The data and safety monitoring board recommended that patients in the dacarbazine group be allowed to cross over to receive vemurafenib, and the protocol was amended accordingly on January 14, 2011, as both overall survival and progression-free survival endpoints had met the prespecified criteria for statistical significance in favor of vemurafenib.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Birmingham, Alabama, United States
, Tucson, Arizona, United States
, Los Angeles, California, United States
, San Francisco, California, United States
, Santa Monica, California, United States
, Aurora, Colorado, United States
, Atlanta, Georgia, United States
, Indianapolis, Indiana, United States
, Boston, Massachusetts, United States
, Boston, Massachusetts, United States
, Boston, Massachusetts, United States
, Detroit, Michigan, United States
, St Louis, Missouri, United States
, New York, New York, United States
, New York, New York, United States
, Chapel Hill, North Carolina, United States
, Portland, Oregon, United States
, Philadelphia, Pennsylvania, United States
, Pittsburgh, Pennsylvania, United States
, Nashville, Tennessee, United States
, Nashville, Tennessee, United States
, Dallas, Texas, United States
, Salt Lake City, Utah, United States
, Seattle, Washington, United States
, Brisbane, , Australia
, Frankston, , Australia
, Malvern, , Australia
, Melbourne, , Australia
, Melbourne, , Australia
, Nedlands, , Australia
, Newcastle, , Australia
, St Leonards, , Australia
, Sydney, , Australia
, Westmead, , Australia
, Woolloongabba, , Australia
, Edmonton, Alberta, Canada
, Winnipeg, Manitoba, Canada
, Hamilton, Ontario, Canada
, Toronto, Ontario, Canada
, Toronto, Ontario, Canada
, Montreal, Quebec, Canada
, Montreal, Quebec, Canada
, Quebec City, Quebec, Canada
, Bordeaux, , France
, Lille, , France
, Marseille, , France
, Montpellier, , France
, Nantes, , France
, Nice, , France
, Paris, , France
, Pierre Benite, , France
, Rouen, , France
, Villejuif, , France
, Buxtehude, , Germany
, Dresden, , Germany
, Erfurt, , Germany
, Essen, , Germany
, Frankfurt, , Germany
, Hannover, , Germany
, Heidelberg, , Germany
, Jena, , Germany
, Kiel, , Germany
, Koeln, , Germany
, Leipzig, , Germany
, Mainz, , Germany
, Minden, , Germany
, Muenchen, , Germany
, Regensburg, , Germany
, Tuebingen, , Germany
, Wuerzburg, , Germany
, Jerusalem, , Israel
, Ramat Gan, , Israel
, Tel Aviv, , Israel
, Bari, , Italy
, Genova, , Italy
, Milano, , Italy
, Milano, , Italy
, Milano, , Italy
, Napoli, , Italy
, Roma, , Italy
, Siena, , Italy
, Amsterdam, , Netherlands
, Amsterdam, , Netherlands
, Groningen, , Netherlands
, Auckland, , New Zealand
, Dunedin, , New Zealand
, Hamilton, , New Zealand
, Palmerston North, , New Zealand
, Wellington, , New Zealand
, Linkoeping, , Sweden
, Lund, , Sweden
, Stockholm, , Sweden
, Umeå, , Sweden
, Uppsala, , Sweden
, Lausanne, , Switzerland
, Zürich, , Switzerland
, Cambridge, , United Kingdom
, Edinburgh, , United Kingdom
, Glasgow, , United Kingdom
, London, , United Kingdom
, London, , United Kingdom
, London, , United Kingdom
, London, , United Kingdom
, Manchester, , United Kingdom
, Newcastle Upon Tyne, , United Kingdom
, Northwood, , United Kingdom
, Nottingham, , United Kingdom
, Oxford, , United Kingdom
, Southampton, , United Kingdom
, Sutton, , United Kingdom
, Swansea, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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