MedTrace Logo

ONC201 in Adults With Recurrent H3 K27M-mutant Glioma

NCT03295396 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2025-07-28

Study results available
· View outcomes & findings →

Summary

This was a Phase 2, open-label, 2-arm study of dordaviprone (ONC201) in patients with recurrent H3 K27M- mutant glioma.

The primary assessment of dordaviprone (ONC201) involved evaluating its anti-tumor activity through the overall response rate according to the Response Assessment in Neuro-Oncology (RANO) criteria for high-grade glioma (HGG).

Conditions

Interventions

DRUG

Dordaviprone (ONC201)

Dordaviprone (ONC201) is a central nervous system (CNS)-penetrant, small-molecule imipridone that acts as a mitochondrial caseinolytic protease P (ClpP) agonist and a dopamine receptor D2 (DRD2) antagonist.

Sponsors & Collaborators

Principal Investigators

  • Allen Mellemed, MD · Chimerix, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-30
Primary Completion
2022-12-31
Completion
2023-07-19
FDA Drug
Yes

Countries

  • United States

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 NCT03295396 on ClinicalTrials.gov