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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 is a Phase 2 study that was terminated before completion, run by Jazz Pharmaceuticals. The registered enrollment target is 73 participants.

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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).

Interventions

  • DRUG Dordaviprone (ONC201)

Trial Details

FieldValue
Enrollment Target 73 participants
Start Date 2017-10-30
Est. Completion 2023-07-19
Phase Phase 2

Sponsor

Jazz Pharmaceuticals

128 total trials

What the Registry Record Tells You About NCT03295396

The ClinicalTrials.gov registry entry for NCT03295396 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 73 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.

NCT03295396 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.