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NCT03295396 · ClinicalTrials.gov registry record · Phase 2
ONC201 in Adults With Recurrent H3 K27M-mutant Glioma
A Phase 2 study, sponsored by Jazz Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 73
- Enrollment target
NCT03295396: Clinical Trial Phase 2 study, sponsored by Jazz Pharmaceuticals.
NCT03295396 is a Phase 2 study that was terminated before completion, run by Jazz Pharmaceuticals. The registered enrollment target is 73 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03295396, a Phase 2 study, was terminated before completion, sponsored by Jazz Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 73 participants
- Enrollment target
Study 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).
Primary Outcome
Quantitative thresholds for objective response by Response Assessment in Neuro-Oncology (RANO) criteria for target lesions on radiographic imaging are Complete Response (CR) is the disappearance of all target lesions; Partial Response (PR) requires a ≥50% decrease in the sum of products of perpendicular diameters of target lesions from baseline. Other considerations for RANO response include assessments of non-target lesions, corticosteroids, and performance status. The Overall Response Rate is
Interventions
- DRUG Dordaviprone (ONC201)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2017-10-30 |
| Est. Completion | 2023-07-19 |
| Phase | Phase 2 |
Why NCT03295396 stopped before completion
NCT03295396 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 1 intervention - of which Dordaviprone (ONC201) is the first listed.
NCT03295396 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03295396 about?
NCT03295396 is a clinical study titled "ONC201 in Adults With Recurrent H3 K27M-mutant Glioma". 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-Oncolog...
What is the current status of trial NCT03295396?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 73 participants. The study started on 2017-10-30. Estimated completion is 2023-07-19.
What interventions are being tested in trial NCT03295396?
The interventions under investigation include: Dordaviprone (ONC201) (DRUG).
Who is sponsoring clinical trial NCT03295396?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03295396's enrollment target sits among peer trials
73 924th of 2000 higher than 1,076 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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