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Oral ONC201 in Adult Recurrent Glioblastoma

NCT02525692 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-12-24

Study results available
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Summary

This was a Phase 2, open-label, 6-arm, multi-center study of dordaviprone (ONC201) in patients with recurrent glioblastoma (Arms A, B, and C), H3 K27M-mutant diffuse glioma (Arm D), or diffuse midline glioma (Arms E and F).

The primary objective of this study was the assessment of dordaivprone (ONC201) anti-tumor activity through progression-free survival at 6 months using Response Assessment in Neuro-Oncology (RANO) criteria for high-grade glioma (HGG).

Conditions

  • Glioblastoma
  • Diffuse Midline Glioma
  • H3 K27M Glioma
  • Thalamic Glioma
  • Infratentorial Glioma
  • Basal Ganglia Glioma

Interventions

DRUG

Dordaviprone (ONC201)

Dordaviprone (ONC201) 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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2023-04-17
Completion
2023-04-17

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 NCT02525692 on ClinicalTrials.gov