Trial · NCT04732065
ONC206 for Treatment of Newly Diagnosed, Recurrent Diffuse Midline Gliomas, and Other Recurrent Malignant CNS Tumors
NCT04732065, Phase 1, Recruiting, Sabine Mueller, MD, PhD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ONC206 for Treatment of Newly Diagnosed, Recurrent Diffuse Midline Gliomas, and Other Recurrent Malignant CNS Tumors. Trials, record NCT04732065. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04732065
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ONC206 for Treatment of Newly Diagnosed, Recurrent Diffuse Midline Gliomas, and Other Recurrent Malignant CNS Tumors
- NCT number
- NCT04732065
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 208 participants, estimated
- Lead sponsor
- Sabine Mueller, MD, PhD
- Conditions
Diffuse Midline Glioma (DMG), Glioblastoma, Recurrent Ependymoma, Recurrent Malignant Central Nervous System Neoplasm, Spinal Cord Glioma, World Health Organization (WHO) Grade III Glioma, CNS Tumor, Central Nervous System Tumor
- Interventions
- ONC206, Standard of Care Radiation Therapy, Optional Proton (1H) MR spectroscopy (MRS)
- First posted
- 2021-02-01
- Last updated
- 2026-06-11
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of participants with dose-limiting toxicities (DLT) | Within 4 weeks after first dose | A DLT is defined as a treatment-related adverse event (AE) or abnormal laboratory value that occurs in the first cycle of treatment (Cycle 1 for Arm A and D; Cycle 0 for Arm B and C), meets criteria for DLT as outlined below and is assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications, and is judged by the investigator to be related to ONC206 as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0). |
| Primary | Maximum tolerated dose (MTD) of ONC206 | Within 4 weeks after first dose | The Bayesian optimal interval (BOIN) design will be used to find the MTD within each arm. MTD is selected based on isotonic regression and this computation is implemented by the shiny app "BOIN" available at http://www.trialdesign.org. Specifically, select as the MTD the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate. If there are ties, select the higher dose level when the isotonic estimate is lower than the target toxicity rate and select the lower dose level when the isotonic estimate is greater than or equal to the target toxicity rate. |
| Secondary | Mean maximum concentration (Cmax) of ONC206 | Day 1 (pre-dose, 0.5, 1, 2, 4, 8 hours (h) post-dose), Day 2 (24 h post-dose for dose 1-5), Day 3 (0.5, 1, 2, 4, and 8h post fifth treatment for dose 6-10) (up to 3 days in total) | Concentration-time data will be summarized by N, Mean, Standard Deviation, Median, Min, Max and 95% Confidence Interval |
| Secondary | Mean corresponding time (Tmax) of ONC206 | Day 1 (pre-dose, 0.5, 1, 2, 4, 8 hours (h) post-dose), Day 2 (24 h post-dose for dose 1-5), Day 3 (0.5, 1, 2, 4, and 8h post fifth treatment for dose 6-10) (up to 3 days in total) | PK parameters will be estimated using standard population PK methodologies and non-linear mixed effect modeling |
| Secondary | Area under the curve (AUC) of ONC206 | Day 1 (pre-dose, 0.5, 1, 2, 4, 8 hours (h) post-dose), Day 2 (24 h post-dose for dose 1-5), Day 3 (0.5, 1, 2, 4, and 8h post fifth treatment for dose 6-10) (up to 3 days in total) | PK parameters will be estimated using standard population PK methodologies and non-linear mixed effect modeling |
| Secondary | Elimination half-life (t1/2) of ONC206 | Day 1 (pre-dose, 0.5, 1, 2, 4, 8 hours (h) post-dose), Day 2 (24 h post-dose for dose 1-5), Day 3 (0.5, 1, 2, 4, and 8h post fifth treatment for dose 6-10) (up to 3 days in total) | PK parameters will be estimated using standard population PK methodologies and non-linear mixed effect modeling |
| Secondary | Mean Total body clearance (CL) for ONC206 | Day 1 (pre-dose, 0.5, 1, 2, 4, 8 hours (h) post-dose), Day 2 (24 h post-dose for dose 1-5), Day 3 (0.5, 1, 2, 4, and 8h post fifth treatment for dose 6-10) (up to 3 days in total) | PK parameters will be estimated using standard population PK methodologies and non-linear mixed effect modeling |
| Secondary | Mean Volume of Distribution (Vd) for ONC206 | Day 1 (pre-dose, 0.5, 1, 2, 4, 8 hours (h) post-dose), Day 2 (24 h post-dose for dose 1-5), Day 3 (0.5, 1, 2, 4, and 8h post fifth treatment for dose 6-10) (up to 3 days in total) | PK parameters will be estimated using standard population PK methodologies and non-linear mixed effect modeling |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01CA266596 | Phase 0/1 trial of ONC206 - a novel imipridone for children with diffuse midline gliomas and recurrent malignant brain tumors | MUELLER, SABINE | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO | NATIONAL CANCER INSTITUTE | 2022 to 2025 |
Source NIH RePORTER
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/NCT04732065
GET https://conductscience.org/api/trials/v1/NCT04732065/registered