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Brief Title: A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers
Official Title: An Open-label, Phase II Study of Vemurafenib in Patients With BRAF V600 Mutation-positive Cancers
Study ID: NCT01524978
Brief Summary: This open-label, multi-center study will assess the efficacy and safety of vemurafenib in participants with BRAF V600 mutation-positive cancers (solid tumors and multiple myeloma, except melanoma and papillary thyroid cancer) and for whom vemurafenib is deemed the best treatment option in the opinion of the investigator. Participants will receive twice daily oral doses of 960 mg vemurafenib until disease progression, unacceptable toxicity, or withdrawal of consent. The safety and efficacy of vemurafenib in combination with cetuximab in a subset of participants with colorectal cancer will also be assessed.
Detailed Description:
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Arizona Oncology, Tucson, Arizona, United States
Rocky Mountain Cancer Centers, LLP, Aurora, Colorado, United States
Massachusetts General Hospital;Oncology, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Washington University, Saint Louis, Missouri, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Vanderbilt, Nashville, Tennessee, United States
University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
Yakima Valley Memorial Hospital/North Star Lodge, Yakima, Washington, United States
Tianjin Cancer Hospital, Tianjin, , China
Institut Bergonie; Oncologie, Bordeaux, , France
Centre Francois Baclesse; Oncologie, Caen, , France
Centre Georges François Leclerc, Dijon, , France
Centre Leon Berard; Departement Oncologie Medicale, Lyon, , France
Institut Paoli-Calmettes; Oncologie Medicale 1, Marseille Cedex 09, , France
Centre Rene Gauducheau, Saint Herblain, , France
Institut Claudius Regaud; Departement Oncologie Medicale, Toulouse, , France
Institut Gustave Roussy; Sitep, VILLEJUIF Cedex, , France
Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung, Essen, , Germany
Klinik der Uni zu Koeln; Klinik I für Innere Medizin; Onkologie, Köln, , Germany
Universitätsklinikum Mannheim, Tagestherapiezentrum, Interdisziplinäres Tumorzentrum, Mannheim, , Germany
Hospital Univ. Central de Asturias; Servicio de Oncologia, Oviedo, Asturias, Spain
Hospital del Mar; Servicio de Oncologia, Barcelona, , Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid, , Spain
Fundacion Jimenez Diaz; Servicio de Oncologia, Madrid, , Spain
Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica, Madrid, , Spain
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia, Salamanca, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia, , Spain
Aberdeen Royal Infirmary, Aberdeen, , United Kingdom
The Royal Marsden Hospital; Dept of Medicine, London, , United Kingdom
The Royal Marsden Hospital, Sutton, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR