ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)
← catalyst calendarNCT05580562 · readout ≤ 680 d
Sponsored by Jazz Pharmaceuticals (industry) · JAZZ — their whole pipeline →. With Chimerix, Inc..
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
510estimated
Sites
162
Countries
Argentina, Australia, Austria +15
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-01-23 | actual | When the study began enrolling |
| Primary completion | Jun 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jun 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2022-10-14 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- H3 K27M
- Glioma
Interventions
- Drug: Dordaviprone (ONC201)
- Drug: Dordaviprone (ONC201) + Placebo
- Other: Placebo
Primary outcome
what the primary-completion date above is the date OFOverall survival (OS)
measured From date of randomization until date of death from any cause, assessed up to approximately 44 months
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