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Title
Status

 

F8394-201 - 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

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F8394-201 - 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

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DiagnosisCancer Harboring BRAF AlterationsStudy StatusOpen
PhaseII
Age10 Years and olderRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Plixorafenib (Oral tablets) Drug: Cobicistat (Oral tablets)
Last Posted Update2024-08-21
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.