Spots Global Cancer Trial Database for A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations
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Trial Identification
Brief Title: A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations
Official Title: A Phase 2 Master Protocol to Assess the Efficacy and Safety of FORE8394, an Inhibitor of BRAF Class 1 and Class 2 Alterations, in Participants With Cancer Harboring BRAF Alterations
Study ID: NCT05503797
Conditions
Study Description
Brief Summary: The objective of this study is to evaluate the efficacy of plixorafenib in participants with locally advanced or metastatic solid tumors, or recurrent or progressive primary central nervous system (CNS) tumors harboring BRAF fusions, or in participants with recurrent high-grade glioma (HGG) harboring BRAF V600E mutation. This will be conducted as two single arm open-label subprotocols (F8394-201A; F8394-201B) under one master protocol.
Detailed Description:
Eligibility
Minimum Age: 10 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
University of California Los Angeles Rheumatology, Westwood, California, United States
University of Miami Hospital and Clinics, Miami, Florida, United States
The John Hopkins Hospital, Baltimore, Maryland, United States
Tufts Medical Center, Boston, Massachusetts, United States
St. Luke's Hospital, Duluth, Minnesota, United States
Mosaic Life Care at Saint Joseph - Medical Center, Saint Joseph, Missouri, United States
Nebraska Cancer Specialists - Midwest Cancer Center - Legacy, Omaha, Nebraska, United States
Overlook Medical Center, Summit, New Jersey, United States
Columbia University Irving Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Toledo Clinic Cancer Center, Toledo, Ohio, United States
Lifespan Cancer Institute - Rhode Island Hospital, Providence, Rhode Island, United States
Baylor Scott & White Research Institute, Dallas, Texas, United States
Baylor Scott & White Medical Center, Temple, Texas, United States
West Virginia University Health Sciences Campus, Morgantown, West Virginia, United States
Sunny brook Health Sciences Centre- Bayview Campus, Toronto, Ontario, Canada
Institut Bergonie, Bordeaux Cedex, Aquitaine, France
Hôpital Nord de Marseille, Marseille, Bouches-du-Rhône, France
Hôpital Morvan, Brest, Finistère, France
Hôpital Universitaire Pitié Salpêtrière, Paris, Ile-de-France, France
Institut de Cancerologie de l'Ouest- Angers, Angers, Pays De La Loire, France
Gustave Roussy, Villejuif, Val-de-Marne, France
Pitié-Salpêtrière Hospital, Paris, , France
Universitätsklinikum Heidelberg, Heidelberg, Baden-Württemberg, Germany
Krankenhaus Nordwest, Frankfurt, Hessen, Germany
Charité - Universitätsmedizin Berlin, Berlin, , Germany
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST, Meldola, Forli-Cesena, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Naples, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele, Milan, , Italy
Catholic University of Korea Saint Vincent's Hospital, Suwon-si, Gyeonggi-do, Korea, Republic of
Seoul National University Hospital, Suwon, Gyeonggido [Kyonggi-do], Korea, Republic of
Dong-A University Hospital, Busan, Gyeongsangnam-do, Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun, Jeollanam-do, Korea, Republic of
Seoul National University Hospital, Seoul, Seoul Teugbyeoisi, Korea, Republic of
Severance Hospital, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Hospital Clinico Universitarlo de Santiago, Santiago De Compostela, A Coruña, Spain
Hospital Clinico Universitarlo de Valencia, València, Valencia, Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Infantil Universitario Niño Jesús, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
Skånes Universitetssjukhus, Lund, Skåne Län, Sweden
Karolinska Universitetssjukhuset, Solna, Stockholms Län, Sweden
The Christie NHS Foundation Trust, Manchester, England, United Kingdom
Sarah Cannon Research Institute, London, , United Kingdom
Contact Details
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