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Dordaviprone (ONC201)

DRUG5 trials

Sponsors

Jazz Pharmaceuticals

Conditions

Basal Ganglia GliomaDiffuse Intrinsic Pontine GliomaDiffuse Midline GliomaEndometrial Cancer RecurrentGlioblastomaGliomaGlioma, MalignantH3 K27M

Phase 1

ONC201 in Pediatric H3 K27M Gliomas
TerminatedNCT03416530
Jazz PharmaceuticalsDiffuse Intrinsic Pontine Glioma, Glioma, Malignant
Start: 2018-01-25End: 2023-05-24Updated: 2025-02-14

Phase 2

Oral ONC201 in Adult Recurrent Glioblastoma
TerminatedNCT02525692
Jazz PharmaceuticalsBasal Ganglia Glioma, Diffuse Midline Glioma, Glioblastoma +3
Start: 2016-01-31End: 2023-04-17Updated: 2024-12-24
ONC201 in Adults With Recurrent H3 K27M-mutant Glioma
TerminatedNCT03295396
Jazz PharmaceuticalsGlioma
Start: 2017-10-30End: 2023-07-19Updated: 2025-07-28
ONC201 in Recurrent or Metastatic Type II Endometrial Cancer Endometrial Cancer
TerminatedNCT03485729
Jazz PharmaceuticalsEndometrial Cancer Recurrent
Start: 2018-03-21End: 2023-01-19Updated: 2024-12-24

Phase 3

ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)
RecruitingNCT05580562
Jazz PharmaceuticalsGlioma, H3 K27M
Start: 2023-01-23End: 2028-06-01Target: 510Updated: 2026-04-16

Related Papers

Geographic access to ONC201 (dordaviprone) trials for pediatric diffuse midline glioma in the United States: County travel burden and social vulnerability gradients.
Journal of Clinical Oncology2026-05-28
10001-NT-1 ACTION: A randomized phase 3 study of dordaviprone (ONC201) in patients with newly diagnosed H3 K27M-mutant diffuse glioma
Neuro-Oncology Advances2025-12-01
TMET-51. EGFR metabolically suppresses differentiation in H3K27M-mutant diffuse midline glioma
Neuro-Oncology2025-11-01
Efficacy and safety of dordaviprone (ONC201) in prospective clinical trials of adult and pediatric recurrent H3 K27M-mutant diffuse glioma patients.
Journal of Clinical Oncology2025-05-283 citations
Imipridones ONC201/ONC206 + RT/TMZ triple (IRT) therapy reduces intracranial tumor burden, prolongs survival in orthotopic IDH-WT GBM mouse model, and suppresses MGMT
Oncotarget2025-03-275 citations
DIPG-12. ASSESSING THE EFFICACY OF BAY2402234 IN COMBINATION WITH ONC201 IN IMMUNE-COMPETENT MURINE MODELS OF DIFFUSE MIDLINE GLIOMA
Neuro-Oncology2024-06-18
Abstract 3173: Impact of hypoxia on the integrated stress response activated by imipridones ONC201 and ONC206 in pediatric diffuse midline glioma cells
Cancer Research2024-03-22
ACTION: a randomized phase 3 study of ONC201 (dordaviprone) in patients with newly diagnosed H3 K27M-mutant diffuse glioma
Neuro-Oncology2024-03-0640 citations
Safety and pharmacokinetics of ONC201 (dordaviprone) administered two consecutive days per week in pediatric patients with H3 K27M-mutant glioma
Neuro-Oncology2024-02-2412 citations
Rational combination platform trial design for children and young adults with diffuse midline glioma: A report from PNOC
Neuro-Oncology2023-12-202 citations
P11.46.A ACTION: A RANDOMIZED PHASE 3 STUDY OF DORDAVIPRONE (ONC201) IN PATIENTS WITH NEWLY DIAGNOSED H3 K27M-MUTANT DIFFUSE GLIOMA
Neuro-Oncology2023-09-011 citations
TIPS-08 ACTION: A RANDOMIZED PHASE 3 STUDY OF DORDAVIPRONE (ONC201) IN PATIENTS WITH NEWLY DIAGNOSED H3 K27M-MUTANT DIFFUSE GLIOMA
Neuro-Oncology Advances2023-08-01
ONC201 in Combination with Paxalisib for the Treatment of H3K27-Altered Diffuse Midline Glioma
Cancer Research2023-05-0574 citations
Abstract CT060: ACTION: A randomized phase 3 study of dordaviprone (ONC201) in patients with newly diagnosed H3 K27M-mutant diffuse glioma
Cancer Research2023-04-14
CTNI-61. CLINICAL EFFICACY AND PREDICTIVE BIOMARKERS OF ONC201 IN H3K27M-MUTANT DIFFUSE MIDLINE GLIOMA
Neuro-Oncology2022-11-014 citations
SYST-07 WINDOW-OF-OPPORTUNITY STUDY OF ONC201 IN PEDIATRIC PATIENTS WITH DIFFUSE INTRINSIC PONTINE GLIOMA (DIPG) AND THALAMIC GLIOMA
Neuro-Oncology Advances2022-08-01
Window-of-opportunity study of ONC201 in pediatric patients with diffuse intrinsic pontine glioma (DIPG) and thalamic glioma.
Journal of Clinical Oncology2022-06-012 citations
Serial H3K27M cell-free tumor DNA (cf-tDNA) tracking predicts ONC201 treatment response and progression in diffuse midline glioma
Neuro-Oncology2022-02-04106 citations
Phase I dose escalation and expansion trial of single agent ONC201 in pediatric diffuse midline gliomas following radiotherapy
Neuro-Oncology Advances2022-01-0155 citations
CTNI-36. SAFETY OF ONC201 ADMINISTERED TWO CONSECUTIVE DAYS PER WEEK IN PEDIATRIC H3 K27M-MUTANT GLIOMA PATIENTS
Neuro-Oncology2021-11-021 citations

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