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

NCT05580562 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2026-04-16

No results posted yet for this 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 dordaviprone (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.

Conditions

Interventions

DRUG

Dordaviprone (ONC201)

Participants ≥ 52.5 kg will receive 625 mg of dordaviprone (5 × 125-mg capsules) dosing days; participants \< 52.5 kg will receive a dose (and corresponding number of capsules) scaled by body weight and rounded to 125-mg increments.

DRUG

Dordaviprone (ONC201) + Placebo

Participants ≥ 52.5 kg will receive 625 mg of dordaviprone (5 × 125-mg capsules) or matching placebo on dosing days; participants \< 52.5 kg will receive a dose (and corresponding number of capsules) scaled by body weight and rounded to 125-mg increments

OTHER

Placebo

Participants will receive placebo (same number of capsules as the dordaviprone dose) on dosing days

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-23
Primary Completion
2028-06-30
Completion
2028-06-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Brazil
  • Canada
  • Denmark
  • Germany
  • Hong Kong
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Singapore
  • South Korea
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05580562 on ClinicalTrials.gov