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Diagnosis | Cancer Harboring BRAF Alterations | Study Status | Open |
Phase | II |
Age | 10 Years and older | Randomisation | NO |
Line of treatment | Disease relapse or progression |
Routes of Treatment Administration | Drug: Plixorafenib (Oral tablets)
Drug: Cobicistat (Oral tablets) |
Last Posted Update | 2024-08-21 |
ClinicalTrials.gov # | NCT05503797 |
International Sponsor
Fore Biotherapeutics
Principal Investigators for Canadian Sites
Sunnybrook Health Sciences Centre - Dr. Mary Jane Lim-Fay
CHU Ste. Justine - Dr. Sébastien Perreault Centres
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
Social worker/patient navigator contact
Marie-Claude Charrette
Clinical research contact
Marie Saint-Jacques
Medical contact
N/A
Social worker/patient navigator contact
N/A
Clinical research contact
Study Description
This study evaluates how effective a drug called plixorafenib is in participants with solid tumors or central nervous system (CNS) tumors with a genetic mutation called a BRAF fusion/BRAF V600E mutation that have progressed or come back.
Inclusion Criteria
- Male and female, ≥10 years of age, and weighing ≥30 kg.
- Diagnosis of a solid tumor or primary CNS tumor that has previously been treated with other standard therapies
- Documentation of BRAF gene fusion in tumor
- Willingness to provide informed consent and comply with study requirements
Other inclusion and exclusion criteria apply and will be discussed with you by the study team.