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NCT05580562 · ClinicalTrials.gov registry record · Phase 3
ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)
A Phase 3 study of Glioma and H3 K27M, sponsored by Jazz Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT05580562: Recruiting Phase 3 study of Glioma and H3 K27M, sponsored by Jazz Pharmaceuticals.
NCT05580562 is a Phase 3 study of Glioma and H3 K27M that is actively recruiting participants, run by Jazz Pharmaceuticals. The registered enrollment target is 450 participants, above the 205-participant average among 87 other Glioma trials with a reported enrollment target (120% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05580562, a Phase 3 study of Glioma and H3 K27M, is actively recruiting participants, sponsored by Jazz Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Overall Survival is defined as the time from randomization to death due to any cause.
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 |
What NCT05580562 shows while recruiting
NCT05580562 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, above the 205-participant average among 87 other Glioma trials with a reported enrollment target (120% higher).
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.
NCT05580562 names 20 study sites across 5 states, led by California, Florida, Arizona.
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.
What interventions are being tested in trial NCT05580562?
The interventions under investigation include: Placebo (OTHER), Dordaviprone (ONC201) (DRUG), Dordaviprone (ONC201) + Placebo (DRUG).
Who is sponsoring clinical trial NCT05580562?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Glioma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05580562's enrollment target sits among peer trials
450 2nd of 87 the highest of 87 other Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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