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

Conditions

• Glioma
• H3 K27M

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Dordaviprone (ONC201) — DRUG
  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.
• Dordaviprone (ONC201) + Placebo — DRUG
  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
• Placebo — OTHER
  Participants will receive placebo (same number of capsules as the dordaviprone dose) on dosing days

Study Details

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.

Key Dates

Start date

Jan 23, 2023

Status verified

Apr 2026

Primary completion

Jun 30, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

510 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dordaviprone Twice Weekly Group
• Experimental: Dordaviprone Once Weekly Group
• Placebo Comparator: Placebo Group

Primary Outcome Measure

Overall survival (OS) [ Time Frame: From date of randomization until date of death from any cause, assessed up to approximately 44 months ]

Central Contacts

• Clinical Trial Disclosure & Transparency
  215-832-3750
  [email protected]

Locations (67)

Find similar trials in Phoenix, AZ

Related Studies

• Magnetic Resonance (MR) Imaging to Determine High Risk Areas in Patients With Malignant Gliomas and to Design Potential Radiation Plans and to Examine Metabolite Changes in Gliomas and Other Solid Tumors
  Recruiting · Memorial Sloan Kettering Cancer Center · New York, New York
• Molecular Testing for the MD Anderson Cancer Center Personalized Cancer Therapy Program
  Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)
  PHASE1/PHASE2 · Recruiting · Plus Therapeutics · Manhasset, New York
• Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA
  PHASE2 · Recruiting · Northwell Health · New York, New York