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Intermediate-size Expanded Access to ONC201 for Patients With H3 K27M-mutant and/or Midline Gliomas | Clinical Trials | Clareo Health

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Intermediate-size Expanded Access to ONC201 for Patients With H3 K27M-mutant and/or Midline Gliomas

NCT04617002•Jazz Pharmaceuticals

View on ClinicalTrials.gov

Summary

This is an intermediate-size expanded access protocol to provide ONC201 (dordaviprone) to patients with H3 K27M-mutant and/or midline gliomas who cannot access ONC201 (dordaviprone) through clinical trials.

Eligibility

Age

0 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient meets one or more of the criteria below:
•Arm A - Closed to further enrollment.
•Arm B - Diffuse intrinsic pontine glioma (DIPG) defined as tumors with a pontine epicenter and diffuse involvement of the pons (at the discretion of the Medical Monitor, the site may be requested to provide the most recent imaging report(s) to confirm diagnosis). H3 K27M status does not have to be known or positive for this arm.
•Arm C -
•1. Patients with primary spinal glioma that is positive for the H3 K27M mutation (performed in a laboratory with Clinical Laboratory Improvement Amendments \[CLIA\] or equivalent certification). Primary spinal glioma must be documented in radiology reporting.
•OR
•2. Patients with diffuse glioma that is positive for the H3 K27M mutation (performed in a laboratory with CLIA or equivalent certification) AND radiographic evidence of leptomeningeal disease. Leptomeningeal disease must be documented in radiology reporting.
•Arm D - Closed to further enrollment.
•Arm E - Patients with H3 K27M-mutant glioma or a midline glioma of unknown H3 K27M mutational status who received ONC201 and/or ONC206 from an alternative (non-Chimerix) source prior to 31 December 2023, as evidenced by supporting documentation (e.g., medical records, pharmacy receipts, etc.). Other supporting documentation may be confirmed by the medical monitor. Detection of H3 K27M mutation should be performed in a CLIA-certified or equivalent laboratory.
•Arm F - Patients with H3 K27M-mutant diffuse glioma who have progressed during or after completion of frontline radiotherapy. Detection of H3 K27M mutation should be performed in a CLIA-certified or equivalent laboratory. Enrollment in this arm will be individually evaluated by the Sponsor and requires at least 3 days for review.
+25 more criteria

Exclusion Criteria

•1. Qualifies for participation in an ongoing ONC201 or ONC206 clinical trial.
•2. Arms B, C, and F: Previous or current enrollment in an ONC201 or ONC206 clinical study (including open-label and blinded studies) or expanded access protocol or previous exposure to ONC201 from any source for the treatment of CNS tumor.
•Arm E: Previous or current enrollment in an ONC201 clinical study (including open label and blinded studies) or expanded access protocol for the treatment of CNS tumor.
•3. Current or planned participation in a study of an investigational agent (including ONC206) or using an investigational device.
•4. (Not applicable; criterion removed in Version 4).
•5. Any known systemic infection that, in the opinion of the Investigator, could compromise the safety of the patient while taking ONC201.
•6. Prolongation of QT/QTcF interval (QTc interval \>480 milliseconds) using Fridericia's QT correction formula on two electrocardiograms (ECGs) separated by at least 2 days.
•7. A history of Torsades de pointes or heart failure, hypokalemia, or family history of prolonged QT Syndrome.
•8. Concomitant use of medication(s) known to prolong the QT/QTc interval.

Locations (23)

BMDACC at Banner University Medical Center Phoenix

Phoenix, Arizona, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Children's Hospital of Orange County

Orange, California, United States

Rady Children's Hospital

San Diego, California, United States

Providence Saint John's Health Center

Santa Monica, California, United States

Children's Hospital of Colorado

Aurora, Colorado, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Miami Cancer Institute

Miami, Florida, United States

University Cancer & Blood Center

Athens, Georgia, United States

Kapi'olani Medical Center for Women and Children

Honolulu, Hawaii, United States

Key Dates

Last Updated

August 20, 2025

Conditions

GliomaH3 K27M

Interventions

ONC201 (dordaviprone)

DRUG

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

NCT06860594

Astrocytoma, IDH-Mutant, Grade 2Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant+5 more

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RECRUITING

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Intermediate-size Expanded Access to ONC201 for Patients With H3 K27M-mutant and/or Midline Gliomas

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

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