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ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)
NCT05580562 · View on ClinicalTrials.gov ↗
Study Summary
This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy.
Interventions
- OTHER Placebo
- DRUG Dordaviprone (ONC201)
- DRUG Dordaviprone (ONC201) + Placebo
Study Locations (20)
California
- UC San Diego Moores Cancer Center — La Jolla
- Kaiser Permanente Los Angeles Medical Center — Los Angeles
- UCLA University of California Los Angeles — Los Angeles
- Children's Hospital of Orange County — Orange
- University of California Irvine — Orange
- UCSF Benioff Children's Hospital — San Francisco
- University of California San Francisco — San Francisco
- Providence Saint John's Cancer Institute — Santa Monica
- Stanford Cancer Center — Stanford
Florida
- Mayo Clinic Jacksonville — Jacksonville
- Miami Cancer Institute — Miami
- St Joseph's Children's Hospital of Tampa — Tampa
- Moffitt Cancer Center — Tampa
- Cleveland Clinic Florida — Weston
Arizona
- Banner MD Anderson Cancer Center — Phoenix
- Barrow Neurological Institute — Phoenix
- Phoenix Childrens Hospital — Phoenix
- Mayo Clinic Arizona — Phoenix
Connecticut
- Yale University — New Haven
District of Columbia
- MedStar Georgetown University Hospital — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2023-01-23 |
| Est. Completion | 2026-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05580562
The ClinicalTrials.gov registry entry for NCT05580562 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jazz Pharmaceuticals, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Glioma appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05580562 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05580562 about?
NCT05580562 is a clinical study titled "ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)". This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in t...
What is the current status of trial NCT05580562?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2023-01-23. Estimated completion is 2026-08.
What conditions does trial NCT05580562 study?
This clinical trial studies the following conditions: Glioma, H3 K27M. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05580562?
The interventions under investigation include: Placebo (OTHER), Dordaviprone (ONC201) (DRUG), Dordaviprone (ONC201) + Placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05580562?
This trial is sponsored by Jazz Pharmaceuticals, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05580562 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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