Trial · NCT02525692
Oral ONC201 in Adult Recurrent Glioblastoma
NCT02525692, Phase 2, Terminated, Jazz Pharmaceuticals; results first posted 2024-12-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oral ONC201 in Adult Recurrent Glioblastoma. Trials, record NCT02525692. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02525692
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral ONC201 in Adult Recurrent Glioblastoma
- NCT number
- NCT02525692
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 84 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Glioblastoma, Diffuse Midline Glioma, H3 K27M Glioma, Thalamic Glioma, Infratentorial Glioma, Basal Ganglia Glioma
- Interventions
- Dordaviprone (ONC201)
- First posted
- 2015-08-17
- Last updated
- 2024-12-24
- Results first posted
- 2024-12-24
- Limitations and caveats
The Sponsor terminated this study based on the initiation of a randomized, Phase 3 study of dordaviprone (ONC201) in an earlier setting; closing this study ensured that enrollment would not be competing against the Phase 3 study. The decision to terminate the study was not related to any safety concerns with dordaviprone (ONC201).~Note that at the time enrollment was halted, some treatment arms had not completed enrollment.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of Patients With Probability of Progression-Free Survival at 6 Months | Progression-free survival assessments were conducted 6 months following treatment initiation. | Progression-free survival rate at 6 months was defined as the percentage of patients who exhibit progression-free survival for \>6 months. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent of Patients With Probability of Progression-Free Survival at 6 Months | Progression-free survival assessments were conducted 6 months following treatment initiation. | Note: In Arm B, one participant with recurrent H3 K27M-mutant glioblastoma and non-measurable disease experienced complete regression of enhancing lesions for \>1.5 years was censored from analysis due to use of anastrozole at baseline and throughout the study. | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent of Patients With Probability of Progression-Free Survival at 6 Months | Arm A | 11.8 | 95% Confidence Interval 2.0 to 31.2 | percentage of patients | |
| Percent of Patients With Probability of Progression-Free Survival at 6 Months | Arm B | 0 | 95% Confidence Interval NA to NA | percentage of patients | |
| Percent of Patients With Probability of Progression-Free Survival at 6 Months | Arm C | NA | 95% Confidence Interval NA to NA | percentage of patients | |
| Percent of Patients With Probability of Progression-Free Survival at 6 Months | Arm D | 14.5 | 95% Confidence Interval 4.6 to 29.8 | percentage of patients | |
| Percent of Patients With Probability of Progression-Free Survival at 6 Months | Arm E | 0 | 95% Confidence Interval NA to NA | percentage of patients | |
| Percent of Patients With Probability of Progression-Free Survival at 6 Months | Arm F | 14.3 | 95% Confidence Interval 0.7 to 46.5 | percentage of patients |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A | 17 | |
| Overall Study | STARTED | Arm B | 19 | |
| Overall Study | STARTED | Arm C | 8 | |
| Overall Study | STARTED | Arm D | 30 | |
| Overall Study | STARTED | Arm E | 3 | |
| Overall Study | STARTED | Arm F | 7 | |
| Overall Study | COMPLETED | Arm A | 0 | |
| Overall Study | COMPLETED | Arm B | 0 | |
| Overall Study | COMPLETED | Arm C | 0 | |
| Overall Study | COMPLETED | Arm D | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events924
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Arm A | 0 | 17 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm B | 1 | 19 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm C | 0 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm D | 6 | 30 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm E | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm F | 0 | 7 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm A | 1 | 17 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm B | 1 | 19 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm C | 0 | 8 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm D | 1 | 30 |
1 to 10 of 924Source ClinicalTrials.gov
See all 924 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A | 16 | 17 |
| Total, all-cause mortality | Arm B | 18 | 19 |
| Total, all-cause mortality | Arm C | 7 | 8 |
| Total, all-cause mortality | Arm D | 20 | 30 |
| Total, all-cause mortality | Arm E | 3 | 3 |
| Total, all-cause mortality | Arm F | 6 | 7 |
| Total, other adverse events | Arm A | 16 | 17 |
| Total, other adverse events | Arm B | 17 | 19 |
| Total, other adverse events | Arm C | 5 | 8 |
| Total, other adverse events | Arm D | 29 | 30 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02525692
GET https://conductscience.org/api/trials/v1/NCT02525692/events?page=2