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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 is a Phase 1 study that was terminated before completion, run by Jazz Pharmaceuticals. The registered enrollment target is 134 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03416530
The ClinicalTrials.gov registry entry for NCT03416530 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jazz Pharmaceuticals, which has 128 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Dordaviprone (ONC201) is the first listed.
NCT03416530 reports 0 study locations.
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.
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