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NCT04732065 · ClinicalTrials.gov registry record · Phase 1
ONC206 for Treatment of Newly Diagnosed, Recurrent Diffuse Midline Gliomas, and Other Recurrent Malignant CNS Tumors
A Phase 1 study of Glioblastoma and Recurrent Ependymoma, sponsored by Sabine Mueller, MD, PhD.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 208
- Enrollment target
- 6
- Study locations
NCT04732065: Recruiting Phase 1 study of Glioblastoma and Recurrent Ependymoma, sponsored by Sabine Mueller, MD, PhD.
NCT04732065 is a Phase 1 study of Glioblastoma and Recurrent Ependymoma that is actively recruiting participants, run by Sabine Mueller, MD, PhD. The registered enrollment target is 208 participants, above the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (93% higher). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04732065, a Phase 1 study of Glioblastoma and Recurrent Ependymoma, is actively recruiting participants, sponsored by Sabine Mueller, MD, PhD.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 208 participants
- Enrollment target
- 6
- Study locations
Study Summary
This phase I trial studies the effects and best dose of ONC206 alone or in combination with radiation therapy in treating patients with diffuse midline gliomas that is newly diagnosed or has come back (recurrent) or other recurrent primary malignant CNS tumors. ONC206 is a recently discovered compound that may stop cancer cells from growing. This drug has been shown in laboratory experiments to kill brain tumor cells by causing a so called "stress response" in tumor cells. This stress response causes cancer cells to die, but without affecting normal cells. ONC206 alone or in combination with radiation therapy may be effective in treating newly diagnosed or recurrent diffuse midline gliomas and other recurrent primary malignant CNS tumors.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG ONC206
- RADIATION Standard of Care Radiation Therapy
- PROCEDURE Optional Proton (1H) MR spectroscopy (MRS)
Study Locations (6)
California
- University of California, San Francisco - San Francisco
Georgia
- Emory University - Atlanta
Michigan
- University of Michigan - Ann Arbor
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Other
- Princess Máxima Center for Pediatric Oncology - Utrecht
Canton of Zurich
- The University Children's Hospital in Zurich - Zurich
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2021-08-23 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 1 |
What NCT04732065 shows while recruiting
NCT04732065 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, above the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (93% higher).
The record links to 8 conditions, with Glioblastoma appearing as the primary indexed condition, and to 3 interventions - of which ONC206 is the first listed.
NCT04732065 lists 6 locations in 6 states (California, Georgia, Michigan).
Frequently Asked Questions
What is clinical trial NCT04732065 about?
NCT04732065 is a clinical study titled "ONC206 for Treatment of Newly Diagnosed, Recurrent Diffuse Midline Gliomas, and Other Recurrent Malignant CNS Tumors". This phase I trial studies the effects and best dose of ONC206 alone or in combination with radiation therapy in treating patients with diffuse midline gliomas that is newly diagnosed or has come back (recurrent) or other recurrent primary malignant CNS tumors. ONC206 is a recently discovered compou...
What is the current status of trial NCT04732065?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 208 participants. The study started on 2021-08-23. Estimated completion is 2027-07-31.
What conditions does trial NCT04732065 study?
This clinical trial studies the following conditions: Glioblastoma, Recurrent Ependymoma, Central Nervous System Tumor, CNS Tumor, Diffuse Midline Glioma (DMG).
What interventions are being tested in trial NCT04732065?
The interventions under investigation include: ONC206 (DRUG), Standard of Care Radiation Therapy (RADIATION), Optional Proton (1H) MR spectroscopy (MRS) (PROCEDURE).
Who is sponsoring clinical trial NCT04732065?
This trial is sponsored by Sabine Mueller, MD, PhD, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04732065 being conducted?
This trial has 6 study locations across California, Georgia, Michigan, Pennsylvania, Canton of Zurich. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04732065's enrollment target sits among peer trials
208 25th of 199 higher than 175 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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