ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)

ClinicalTrials.gov ID: NCT05580562

Public ClinicalTrials.gov record NCT05580562. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Jul 21, 2026, 9:17 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study

Study identification

NCT ID: NCT05580562
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Jazz Pharmaceuticals; Industry
Enrollment: 510 participants

Conditions and interventions

Conditions

Interventions

Dordaviprone (ONC201) Drug
Dordaviprone (ONC201) + Placebo Drug
Placebo Other

Drug · Other

Eligibility (public fields only)

Age range: Not listed
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jan 22, 2023
Primary completion: May 31, 2028
Completion: May 31, 2028
Last update posted: Apr 15, 2026

2023 – 2028

United States locations

U.S. sites: 67
U.S. states: 31
U.S. cities: 51

Facility	City	State	ZIP	Site status
Banner MD Anderson Cancer Center	Phoenix	Arizona	85006	Completed
Barrow Neurological Institute	Phoenix	Arizona	85013	Active, not recruiting
Phoenix Childrens Hospital	Phoenix	Arizona	85016	Completed
Mayo Clinic Arizona	Phoenix	Arizona	85054	Completed
UC San Diego Moores Cancer Center	La Jolla	California	92093	Active, not recruiting
Kaiser Permanente Los Angeles Medical Center	Los Angeles	California	90027	Completed
UCLA University of California Los Angeles	Los Angeles	California	90095	Completed
Children's Hospital of Orange County	Orange	California	92868	Completed
University of California Irvine	Orange	California	92868	Active, not recruiting
UCSF Benioff Children's Hospital	San Francisco	California	94143	Active, not recruiting
University of California San Francisco	San Francisco	California	94143	Active, not recruiting
Providence Saint John's Cancer Institute	Santa Monica	California	90404	Active, not recruiting
Stanford Cancer Center	Stanford	California	94350	Completed
Yale University	New Haven	Connecticut	06511	Active, not recruiting
MedStar Georgetown University Hospital	Washington D.C.	District of Columbia	20007	Completed
Mayo Clinic Jacksonville	Jacksonville	Florida	32224	Active, not recruiting
Miami Cancer Institute	Miami	Florida	33176	Active, not recruiting
St Joseph's Children's Hospital of Tampa	Tampa	Florida	33607	Completed
Moffitt Cancer Center	Tampa	Florida	33612	Active, not recruiting
Cleveland Clinic Florida	Weston	Florida	33331	Completed
Children's Healthcare of Atlanta	Atlanta	Georgia	30342	Completed
Kapi'olani Medical Center for Women and Children	Honolulu	Hawaii	96826	Completed
Feinberg School of Medicine Northwestern University	Chicago	Illinois	60611	Active, not recruiting
Indiana University School of Medicine - Indianapolis	Indianapolis	Indiana	46202	Active, not recruiting
University of Iowa Hospitals & Clinics	Iowa City	Iowa	52242	Active, not recruiting
Norton Healthcare	Louisville	Kentucky	40241	Active, not recruiting
Ochsner Medical Center - New Orleans	New Orleans	Louisiana	70121	Completed
University of Maryland School of Medicine	Baltimore	Maryland	21201	Completed
Massachusetts General Hospital Cancer Center	Boston	Massachusetts	02114	Active, not recruiting
Dana Farber Cancer Institute	Boston	Massachusetts	02215	Active, not recruiting
University of Michigan Hospital	Ann Arbor	Michigan	48109	Active, not recruiting
University of Minnesota	Minneapolis	Minnesota	55455	Active, not recruiting
Mayo Clinic - Cancer Center - Rochester	Rochester	Minnesota	55905	Active, not recruiting
Washington University School of Medicine/St. Louis Children's Hospital	St Louis	Missouri	63110	Active, not recruiting
Benefis Hospital Sletten Cancer Institute	Great Falls	Montana	59405	Withdrawn
University of Nebraska Medical Center	Omaha	Nebraska	68114	Completed
Jersey Shore University Medical Center	Neptune City	New Jersey	07753	Active, not recruiting
Overlook Medical Center	Summit	New Jersey	07901	Active, not recruiting
Albany Medical Center	Albany	New York	12208	Completed
Children's Hospital at Montefiore Medical Center	New York	New York	10029	Completed
Montefiore Medical Park	New York	New York	10029	Active, not recruiting
Laura & Isaac Perlmutter Cancer Center - NYU ACC	New York	New York	10032-3726	Active, not recruiting
Columbia University Medical Center	New York	New York	10032	Active, not recruiting
Lenox Hill Hospital	New York	New York	10075	Completed
University of Rochester Medical Center	Rochester	New York	14642	Completed
Levine Cancer Institute/ Atrium Health	Charlotte	North Carolina	28204	Active, not recruiting
Duke Cancer Institute	Durham	North Carolina	27710	Active, not recruiting
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	45229	Active, not recruiting
Cleveland Clinic	Cleveland	Ohio	44195	Active, not recruiting
Ohio State University	Columbus	Ohio	43210	Active, not recruiting
University of Oklahoma Peggy and Charles Stephenson Cancer Center	Oklahoma City	Oklahoma	73104	Active, not recruiting
Providence Health and Services St. Vincent Medical Center	Portland	Oregon	97239	Active, not recruiting
University of Pennsylvania	Philadelphia	Pennsylvania	19104	Active, not recruiting
Thomas Jefferson University	Philadelphia	Pennsylvania	19107	Active, not recruiting
UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	15232	Completed
UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania	15232	Completed
Dell Children's Medical Center of Central Texas	Austin	Texas	78723	Completed
Neuro-Oncology Associates	Dallas	Texas	75246	Active, not recruiting
University of Texas Southwestern Medical Center	Dallas	Texas	75390	Active, not recruiting
University of Texas MD Anderson Cancer Center	Houston	Texas	77030	Active, not recruiting
UT Health Houston Neurosciences - Texas Medical Center	Houston	Texas	77030	Completed
University of Texas - San Antonio - Health Science Center	San Antonio	Texas	78229	Active, not recruiting
University of Utah - Huntsman Cancer Institute	Salt Lake City	Utah	84112	Active, not recruiting
Inova Schar Cancer Institute	Fairfax	Virginia	22031	Active, not recruiting
Children's Hospital of The King's Daughter	Norfolk	Virginia	23507	Completed
University of Washington	Seattle	Washington	98195	Active, not recruiting
University Of Wisconsin - Madison	Madison	Wisconsin	53792	Active, not recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 95 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05580562, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Apr 15, 2026 · Synced Jul 21, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05580562 live on ClinicalTrials.gov.

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