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ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)

Study acronym: ACTION
StatusRecruiting
PhasePhase 3
Started2023-01-23
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 66 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-04-13
Study Status, Sponsor/Collaborators, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v65
Primary completion date2026-08→2028-06
Completion date2026-08→2028-06
Enrollment target450→510
Eligibility criteria+15 characters
[...] equivalent laboratory). [Site to provide (as available): ≥ 1011 unstained formalin-fixed paraffin-embedded (FFPE) slides fr [...] s within the specified time periods prior to randomization: Dordaviprone (ONC201) or ONC206 at any time. Systemic bevacizumab (includes biosi [...]
Secondary endpoints5 to 22 entries
Progression Free Survival (PFS) using RANO 2.0 Criteria for All Participants PFS Using RANO 2.0 Criteria for Participants with Measurable Contrast-HGGEnhancing criteriaDisease Distribution of Graded Clinical Laboratory Parameter Time to First Corticosteroid Response Duration of First Corticosteroid Response Cumulative Duration of Corticosteroid Responses Corticosteroid Dose and Change from Baseline Over Time Time to Corticosteroid Use Deterioration Time to first p [...]
Primary endpoints2 to 1 entries
Progression free survival (PFS) as assessed by using RANO-HGG criteria
Study sitesdetails revised at 24 of 162 sites
Collaborators+14 characters
Chimerix, Inc.
2025-08-25
Study Status, Contacts/Locations v64
Study sites160→162
2025-07-07
Study Status, Contacts/Locations v63
Study sites159→160
2025-06-05
Study Status, Contacts/Locations v62
Study sites157→159
2025-02-28
Study Status, Contacts/Locations v61
Study sites158→157
Show 45 earlier versions
2025-02-26
Study Status, Contacts/Locations v60
Study sitescontacts updated at 1 of 158 sites
2025-01-28
Study Status, Contacts/Locations v59
Study sites156→158
2025-01-02
Study Status, Contacts/Locations v58
Study sites152→156
2024-12-10
Study Status, Contacts/Locations v57
Study sites149→152
2024-11-12
Study Status, Contacts/Locations v56
Study sites148→149
2024-10-25
Study Status, Contacts/Locations v55
Study sites147→148
2024-10-15
Study Status, Contacts/Locations v54
Study sites145→147
2024-10-07
Study Status, Contacts/Locations v53
Study sites142→145
2024-09-06
Study Status, Contacts/Locations v52
Study sites141→142
2024-08-02
Study Status, Arms and Interventions v51
InterventionsONC201 (Drug), ONC201 + Placebo (Drug), Placebo (Other)→Dordaviprone (ONC201) (Drug), Dordaviprone (ONC201) + Placebo (Drug), Placebo (Other)
2024-06-14
Study Status, Contacts/Locations v50
Study sites140→141
2024-05-28
Study Status, Contacts/Locations v49
Study sites139→140
2024-05-20
Study Status, Contacts/Locations v48
Study sites138→139
2024-05-13
Study Status, Contacts/Locations v47
Study sitescontacts updated at 1 of 138 sites
2024-05-09
Study Status, Contacts/Locations v46
Study sites134→138
2024-04-08
Study Status, Contacts/Locations v45
Study sites133→134
2024-04-01
Study Status, Contacts/Locations v44
Study sites131→133
2024-03-04
Study Status, Contacts/Locations v43
Study sites130→131
2024-02-13
Study Status, Contacts/Locations v42
Study sites128→130
2024-01-29
Study Status, Contacts/Locations v41
Study sites127→128
2024-01-19
Study Status, Contacts/Locations v40
Study sites124→127
2024-01-08
Study Status, Eligibility, Contacts/Locations v39
Study sites123→124
Eligibility criteria+315 characters
[...] ed 2 to 6 weeks after completion of frontline radiotherapy. If unable to obtain contrast-enhanced imaging due to lack of venous access after multiple attempts, a patient may still be eligible after collection of a nonenhanced MRI of the brain. [Site to also provide all available MRIs completed prior to initiating treatment with study intervention.] Completed standardReceived frontline radiotherapy Initiated radiotherapy within 12 weeks from the initial diagnosis of H3 K27M-mutant diffuse glioma. Completed radiotherapy within 2 to 6 weeks prior to randomization. StandardCompleted frontlinestand [...] [...]
2023-12-15
Study Status, Contacts/Locations v38
Study sites121→123
2023-12-11
Study Status, Contacts/Locations v37
Study sites119→121
2023-11-27
Study Status, Contacts/Locations v36
Study sites117→119
2023-11-20
Study Status, Contacts/Locations v35
Study sites116→117
2023-11-13
Study Status, Contacts/Locations v34
Study sites113→116
2023-10-30
Study Status, Contacts/Locations v33
Study sites110→113
2023-10-16
Study Status, Contacts/Locations v32
Study sites107→110
2023-10-03
Study Status, Contacts/Locations v31
Study sites96→107
2023-09-25
Study Status, Contacts/Locations v30
Study sites95→96
2023-09-20
Study Status, Contacts/Locations v29
Study sites89→95
2023-09-11
Study Status, Contacts/Locations v28
Study sites88→89
2023-09-05
Study Status, Contacts/Locations v27
Study sites85→88
2023-08-28
Study Status, Contacts/Locations v26
Study sites81→85
2023-08-18
Study Status, Contacts/Locations v25
Study sitescontacts updated at 1 of 81 sites
2023-08-11
Study Status, Contacts/Locations v24
Study sites77→81
2023-07-24
Study Status, Contacts/Locations v23
Study sites72→77
2023-07-11
Study Status, Contacts/Locations v22
Study sites59→72
2023-06-23
Study Status, Contacts/Locations v21
Study sites48→59
2023-06-16
Study Status, Contacts/Locations v20
Study sites46→48
2023-06-12
Study Status, Contacts/Locations v19
Study sites43→46
2023-06-01
Study Status, Contacts/Locations v18
Study sites35→43
2023-05-30
Study Status, Contacts/Locations v17
Study sites30→35
2023-05-22
Study Status, Contacts/Locations v16
Study sites23→30
Jazz Pharmaceuticals
34 trials monitored
See 1 trial at risk
Glioma
666 trials monitored
See 38 trials at risk
This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with dordaviprone (ONC201) following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy.
Trial Details
NCT Number NCT05580562
Lead Sponsor Jazz Pharmaceuticals
Collaborators: Chimerix, Inc.
Conditions H3 K27M, Glioma
Enrollment 510 participants
Start Date 2023-01-23
Primary Completion 2028-06 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-04-16