The ACTION Study: ONC201 for H3 K27M-mutant Diffuse Glioma
This study, called the ACTION Study, is testing a drug called dordaviprone (ONC201) in people with a type of brain tumor called H3 K27M-mutant diffuse glioma. This is a new diagnosis of glioma, and you must have already completed standard radiation therapy. Researchers want to see if dordaviprone (ONC201) can help people live longer after their initial treatment. Some participants will receive dordaviprone (ONC201), and others will receive a placebo (an inactive substance that looks like the drug). The study is looking at how long people live overall. This is an international study planning to enroll 510 participants.
- Study design
- This is a randomized, double-blind (meaning neither you nor your doctor will know if you're getting the drug or placebo), placebo-controlled study with 510 planned participants.
- What's involved
- Participants will receive dordaviprone (ONC201) or placebo capsules on specific dosing days. The dose will be adjusted based on body weight.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your overall survival will be assessed from the date you are assigned to a group until your death, for up to approximately 44 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)
At a glance
Conditions
Where it's being run
162 sites across 78 statesWho to contact
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What this trial measures
- Overall survival (OS)From date of randomization until date of death from any cause, assessed up to approximately 44 months
Overall Survival is defined as the time from randomization to death due to any cause.