ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)

Last updated:
2026-07-18
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View trial details

Overview

Official protocol title:

ONC201 FOR THE TREATMENT OF NEWLY DIAGNOSED H3 K27M-MUTANT DIFFUSE GLIOMA FOLLOWING COMPLETION OF RADIOTHERAPY: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY

Intervention/treatment:
DORDAVIPRONE (ONC201)
Medical condition:
GLIOMA
Protocol code:
ONC201-108 (U1111-1285-3702)
Control number:
271886
Status:
Recruiting
Approved:
February 28, 2023
Trial phase:
Phase 3
For more information:
ClinicalTrials.gov - NCT05580562
This is an external link. The information is not authorized by the Government of Canada.

Eligibility

Sex: ALL
Age
Accepts healthy volunteers: No

Contacts and locations

Contact
Name
Clinical Trial Disclosure & Transparency
Role
CONTACT
Phone:
215-832-3750
Sponsor
CHIMERIX INC

Locations

Alberta

Tom Baker Cancer Cetre
Calgary, Alberta, T2N 2T9
Recruiting
Name
Paula De Robles, MD
Role
CONTACT
Name
Paula De Robles, MD
Role
PRINCIPAL_INVESTIGATOR

British Columbia

BC Cancer - The Vancouver Center
Vancouver, British Columbia, V5Z 4E6
Recruiting
Name
Rebecca Harrison, MD
Role
CONTACT
Phone:
+1-604-877-6000
Name
Rebecca Harrison, MD
Role
PRINCIPAL_INVESTIGATOR
Children's & Women's Health Care of BC
Vancouver, British Columbia, V6H 0B3
Recruiting
Name
George Michaiel
Role
CONTACT
Name
George Michaiel
Role
PRINCIPAL_INVESTIGATOR

Ontario

Childrens Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Recruiting
Name
Donna Johnston, MD
Role
CONTACT
Name
Donna Johnston, MD
Role
PRINCIPAL_INVESTIGATOR
London Health Sciences Centre
London, Ontario, N6A 5W9
Recruiting
Name
Seth Climans, MD
Role
CONTACT
Name
Seth Climans, MD
Role
PRINCIPAL_INVESTIGATOR
Princess Margaret Hospital
Toronto, Ontario, M5G 1X8
Recruiting
Name
Julie Bennett, MD
Role
CONTACT
Name
Julie Bennett, MD
Role
PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Recruiting
Name
Mary Lim-Fat, MD
Role
CONTACT
Name
Mary Lim-Fat, MD
Role
PRINCIPAL_INVESTIGATOR

Quebec

Hopital Notre Dame, Lachapelle
Montreal, Quebec, H2X 3E4
Recruiting
Name
Sarah Lapointe
Role
CONTACT
Name
Sarah Lapointe
Role
PRINCIPAL_INVESTIGATOR
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