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NCT05009992 · ClinicalTrials.gov registry record · Phase 2
Combination Therapy for the Treatment of Diffuse Midline Gliomas
A Phase 2 study of Diffuse Intrinsic Pontine Glioma and Diffuse Midline Glioma, H3 K27M-Mutant, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 360
- Enrollment target
- 20
- Study locations
NCT05009992 is a Phase 2 study of Diffuse Intrinsic Pontine Glioma and Diffuse Midline Glioma, H3 K27M-Mutant that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 360 participants, above the 122-participant average among 28 other Diffuse Intrinsic Pontine Glioma trials with a reported enrollment target (195% higher). The trial reports 20 study locations across 18 states.
The verdict
NCT05009992, a Phase 2 study of Diffuse Intrinsic Pontine Glioma and Diffuse Midline Glioma, H3 K27M-Mutant, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 360 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial determines if the combination of ONC201 with different drugs is effective for treating participants with diffuse midline gliomas (DMGs). Despite years of research, little to no progress has been made to improve outcomes for participants with DMGs, and there are few treatment options. This trial will utilize an adaptive platform design in that the different treatment arms for each cohort will be opened and closed based on ongoing preclinical investigation as well as evolving outcome data from the trial. Novel agents will be continuously added to this study as pre-clinical data emerge to suggest additive or synergistic activity when combined ONC201. Should a novel agent not have an RP2D at the time of incorporation into this study, a phase 1 lead-in will be performed prior to initiation of combination therapy (via study amendment).
Conditions Studied
Interventions
- RADIATION Radiation Therapy
- DRUG Paxalisib
- DRUG ONC201
- DRUG DNX-2401
Study Locations (20)
California
- Children's Hospital Los Angeles - Los Angeles
- University of California, San Diego / Rady Children's Hospital, San Diego - San Diego
- University of California, San Francisco - San Francisco
Alabama
- University of Alabama at Birmingham - Birmingham
District of Columbia
- Children's National Hospital - Washington D.C.
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Indiana
- Indiana University Riley Children's Hospital - Indianapolis
Maryland
- Johns Hopkins University - Baltimore
Massachusetts
- Dana-Farber Cancer Institute Harvard University - Boston
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2021-10-20 |
| Est. Completion | 2029-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05009992
The ClinicalTrials.gov registry entry for NCT05009992 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 122-participant average among 28 other Diffuse Intrinsic Pontine Glioma trials with a reported enrollment target (195% higher). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Diffuse Intrinsic Pontine Glioma appearing as the primary indexed condition, and to 4 interventions - of which Radiation Therapy is the first listed.
NCT05009992 reports 20 study locations spanning 18 distinct geographic areas - top geographies include California, Alabama, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT05009992 about?
NCT05009992 is a clinical study titled "Combination Therapy for the Treatment of Diffuse Midline Gliomas". This phase II trial determines if the combination of ONC201 with different drugs is effective for treating participants with diffuse midline gliomas (DMGs). Despite years of research, little to no progress has been made to improve outcomes for participants with DMGs, and there are few treatment opti...
What is the current status of trial NCT05009992?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 360 participants. The study started on 2021-10-20. Estimated completion is 2029-06-30.
What conditions does trial NCT05009992 study?
This clinical trial studies the following conditions: Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant, WHO Grade III Glioma, Recurrent WHO Grade III Glioma, Recurrent Diffuse Intrinsic Pontine Glioma.
What interventions are being tested in trial NCT05009992?
The interventions under investigation include: Radiation Therapy (RADIATION), Paxalisib (DRUG), ONC201 (DRUG), DNX-2401 (DRUG).
Who is sponsoring clinical trial NCT05009992?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05009992 being conducted?
This trial has 20 study locations across Alabama, California, District of Columbia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.