Spots Global Cancer Trial Database for A Study of FORE8394 as a Single Agent in Patients With Advanced Unresectable Solid Tumors
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Trial Identification
Brief Title: A Study of FORE8394 as a Single Agent in Patients With Advanced Unresectable Solid Tumors
Official Title: A Phase 1/2a Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of FORE8394 in Patients With Advanced Unresectable Solid Tumors
Study ID: NCT02428712
Interventions
Study Description
Brief Summary: The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated dose/recommended Phase 2 dose, and efficacy of FORE8394.
Detailed Description: Dose Escalation (Part 1): To evaluate safety, pharmacokinetics, pharmacodynamics of FORE8394 in adult and pediatric patients with advanced BRAF- mutated tumors, and to identify the recommended Phase 2 Dose. Dose Extension (Part 2): To access objective tumor response to FORE8394 treatment in adult and in adolescent patients with advanced BRAF- mutated tumors, to access RECIST, and to access pharmacokinetics, pharmacodynamics, and safety.
Keywords
Eligibility
Minimum Age: 10 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
HonorHealth, Scottsdale, Arizona, United States
St. Joseph's Hospital at Orange, Orange, California, United States
Stanford Hospitals and Clinics, Stanford, California, United States
University of Miami, Miami, Florida, United States
Community Health Network, Indianapolis, Indiana, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Capital Regional Medical Center, Jefferson City, Missouri, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Baptist Cancer Center, Memphis, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Texas Children's Hospital (Baylor College of Medicine), Houston, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Contact Details
Name: Stacie Peacock Shepherd, MD, PhD
Affiliation: Fore Biotherapeutics U.S. Inc.
Role: STUDY_CHAIR
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