# ONC201 in Pediatric H3 K27M Gliomas

> **NCT03416530** · PHASE1 · TERMINATED · sponsor: **Jazz Pharmaceuticals** · enrollment: 134 (actual)

## Conditions studied

- Diffuse Intrinsic Pontine Glioma
- Glioma, Malignant

## Interventions

- **DRUG:** Dordaviprone (ONC201)

## Key facts

- **NCT ID:** NCT03416530
- **Lead sponsor:** Jazz Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2018-01-25
- **Primary completion:** 2022-12-31
- **Final completion:** 2023-05-24
- **Target enrollment:** 134 (ACTUAL)
- **Why stopped:** The Sponsor terminated the study to prioritize enrollment in a randomized Phase 3 trial of ONC201 in an earlier setting. This decision was unrelated to any safety concerns with dordaviprone (ONC201).
- **Last updated:** 2025-02-14

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03416530

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03416530, "ONC201 in Pediatric H3 K27M Gliomas". Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/clinical/NCT03416530. Licensed CC0.

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