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ONC201 in Pediatric H3 K27M Gliomas

NCT03416530 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2025-02-14

No results posted yet for this study

Summary

This was a Phase 1, open label, multicenter, 8-arm, dose escalation study of dordaviprone (ONC201) in pediatric patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) and recurrent/refractory H3 K27M-mutant gliomas.

The primary endpoint of this study was to determine the recommended Phase 2 dose (RP2D) of dordaviprone (ONC201) in pediatric glioma patients as a single agent in combination with radiation.

Conditions

  • Diffuse Intrinsic Pontine Glioma
  • Glioma, Malignant

Interventions

DRUG

Dordaviprone (ONC201)

Dordaviprone is a brain-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
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-25
Primary Completion
2022-12-31
Completion
2023-05-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT03416530 on ClinicalTrials.gov