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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 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.
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.
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 205-participant average among 87 other Glioma trials with a reported enrollment target (120% higher). The listed sponsor is Jazz Pharmaceuticals, which has 128 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.