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Title
Status

 

ONC201 - ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study

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ONC201 - ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study

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DiagnosisGliomaStudy StatusOpen
PhaseIII
AgeN/ARandomisationYES
Line of treatmentFirst line treatment
Routes of Treatment AdministrationONC201 and placebo medication are capsules, taken by mouth
Last Posted Update2024-04-16
ClinicalTrials.gov #NCT05580562
International Sponsor
Chimerix
Principal Investigators for Canadian Sites
London Health Sciences Centre - Dr. Seth Climans (Adult only)
Children's Hospital Eastern Ontario (CHEO) - Dr. Donna Johnston
Sunnybrook Health Sciences Centre - Dr. Mary Jane Lim Fat
Princess Margaret Hospital - Dr. Julie Bennett
Centres
Medical contact
Dr. Donna Johnston
Dr. Lesleigh Abbott
Dr. Doaa Abdel Fattah
 
Social worker/patient navigator contact
Sherley Telisma
 
Clinical research contact
Carol Duchenne
 
Medical contact
Dr. Alexandra Zorzi
Dr. Shayna Zelcer
 
Social worker/patient navigator contact
Cindy Milne Wren
Jessica Mackenzie Harris
 
Clinical research contact
Mariam Mikhail
Medical contact
N/A
Social worker/patient navigator contact
N/A
Clinical research contact
N/A
Medical contact
N/A
Social worker/patient navigator contact
N/A
Clinical research contact
N/A

 

 

Study Description

This is a phase 3 study for patients with newly diagnosed diffuse glioma. To be eligible for this study, the participant's cancer must have a mutation called H3 K27M. This study explores whether adding treatment with the experimental drug called ONC201 after radiotherapy is effective in patients with this type of cancer. 

Inclusion Criteria
  • Able to understand the study procedures and agree to participate in the study by providing written informed consent and assent when applicable.
  • Body weight ≥ 10 kg
  • A new diagnosis of diffuse glioma with a H3 K27M mutation 
  • Received frontline radiotherapy (radiation) within 2-6 weeks of starting this study
  • Patient must be capable of self-care but may be unable to engage in normal activities or perform active work

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.