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| Diagnosis | Glioma | Study Status | Open |
| Phase | III |
| Age | N/A | Randomisation | YES |
| Line of treatment | First line treatment |
| Routes of Treatment Administration | ONC201 and placebo medication are capsules, taken by mouth
|
| Last Posted Update | 2024-06-11 |
| ClinicalTrials.gov # | NCT05580562 |
International Sponsor
ChimerixPrincipal Investigators for Canadian Sites
BC Children's Hospital - Dr. Michaiel George
Children's Hospital Eastern Ontario (CHEO) - Dr. Donna Johnston
AYA:
Sunnybrook Health Sciences Centre - Dr. Mary Jane Lim Fat
Princess Margaret Hospital - Dr. Julie Bennett
London Health Sciences Centre - Dr. Seth Climans (Adult only)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
Medical contact
Rebecca Deyell
Social worker/patient navigator contact
Ilana Katz
Clinical research contact
Hem/Onc/BMT Clinical Trials Unit
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.
