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NCT03416530 · ClinicalTrials.gov registry record · Phase 1
ONC201 in Pediatric H3 K27M Gliomas
A Phase 1 study, sponsored by Jazz Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 134
- Enrollment target
NCT03416530: Clinical Trial Phase 1 study, sponsored by Jazz Pharmaceuticals.
NCT03416530 is a Phase 1 study that was terminated before completion, run by Jazz Pharmaceuticals. The registered enrollment target is 134 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (123% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03416530, a Phase 1 study, was terminated before completion, sponsored by Jazz Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 134 participants
- Enrollment target
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.
Primary Outcome
Determination of recommended Phase 2 dose (RP2D) as a single agent or in combination with radiation
Interventions
- DRUG Dordaviprone (ONC201)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2018-01-25 |
| Est. Completion | 2023-05-24 |
| Phase | Phase 1 |
Why NCT03416530 stopped before completion
NCT03416530 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (123% higher).
The record links to 0 conditions, and to 1 intervention - of which Dordaviprone (ONC201) is the first listed.
NCT03416530 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03416530 about?
NCT03416530 is a clinical study titled "ONC201 in Pediatric H3 K27M Gliomas". 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 ...
What is the current status of trial NCT03416530?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 134 participants. The study started on 2018-01-25. Estimated completion is 2023-05-24.
What interventions are being tested in trial NCT03416530?
The interventions under investigation include: Dordaviprone (ONC201) (DRUG).
Who is sponsoring clinical trial NCT03416530?
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 NCT03416530's enrollment target sits among peer trials
134 427th of 2000 higher than 1,569 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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