Spots Global Cancer Trial Database for Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1
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Trial Identification
Brief Title: Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1
Official Title: A Multi-center, Open-label, Single-arm Phase I Dose-escalation and Phase II Dose-expansion Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1
Study ID: NCT04954001
Interventions
Study Description
Brief Summary: FCN-159 is a highly active MEK1/2 inhibitor that was designed, synthesized and screened on the basis of the structure of trametinib. FCN-159 is an orally available and highly potent selective inhibitor of MEK1/2, which is expected to be a targeted therapy for the treatment of advanced solid tumors and neurofibromatosis type 1.
Detailed Description:
Keywords
Eligibility
Minimum Age: 2 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital Los Angeles, Los Angeles, California, United States
Principal Investigator Hans, Gainesville, Florida, United States
John Hopkins All Children Hospital, Saint Petersburg, Florida, United States
Henry Ford Health System, Detroit, Michigan, United States
Medical University of South Carolina - Hollings Cancer Center - PPDS, Charleston, South Carolina, United States
Research Site, Beijing, , China
Research Site, Guangzhou, , China
Research Site, Hangzhou, , China
Research Site, Shanghai, , China
Research Site, Shijiazhuang, , China
Research Site, Wuhan, , China
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Contact Details
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