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NCT05376800 · ClinicalTrials.gov registry record · Phase 1
A Study to Determine How BI 907828 (Brigimadlin) is Taken up in the Tumor (Phase 0) and to Determine the Highest Dose of BI 907828 (Brigimadlin) That Could be Tolerated (Phase 1a) in Combination With Radiation Therapy in People With a Brain Tumor Called Glioblastoma
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT05376800 is a Phase 1 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 24 participants.
The verdict
NCT05376800, a Phase 1 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study is open to adults with newly diagnosed glioblastoma, a type of brain tumor. The study has two parts. Part 1 is open to people who can get their brain tumor removed by surgery. Part 2 is open to people who already had such a brain surgery. This study tests a medicine called BI 907828 (Brigimadlin). BI 907828 (Brigimadlin) is a socalled MDM2 inhibitor that is being developed to treat cancer. The purpose of Part 1 of the study is to find out how BI 907828 (Brigimadlin) is taken up in the tumor. Participants take a single dose of BI 907828 (Brigimadlin) as a tablet before the brain surgery. Part 1 of the study takes about 1 month. During this time, participants have their brain tumor removed by surgery and visit the study site about 8 times. The purpose of Part 2 is to find the highest dose of BI 907828 (Brigimadlin) that the participants can tolerate in combination with standard radiation therapy. During the first 6 weeks, participants get standard radiation therapy. In addition, they take a dose of BI 907828 (Brigimadlin) once every 3 weeks. Participants may continue to take BI 907828 (Brigimadlin) as long as they benefit from treatment and can tolerate it. They visit the study site regularly. During the entire study, doctors also regularly check participants' health and take note of any unwanted effects.
Interventions
- DRUG BI 907828 (Brigimadlin)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-11-30 |
| Est. Completion | 2025-07-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05376800
The ClinicalTrials.gov registry entry for NCT05376800 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BI 907828 (Brigimadlin) is the first listed.
NCT05376800 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05376800 about?
NCT05376800 is a clinical study titled "A Study to Determine How BI 907828 (Brigimadlin) is Taken up in the Tumor (Phase 0) and to Determine the Highest Dose of BI 907828 (Brigimadlin) That Could be Tolerated (Phase 1a) in Combination With Radiation Therapy in People With a Brain Tumor Called Glioblastoma". This study is open to adults with newly diagnosed glioblastoma, a type of brain tumor. The study has two parts. Part 1 is open to people who can get their brain tumor removed by surgery. Part 2 is open to people who already had such a brain surgery. This study tests a medicine called BI 907828 (Bri...
What is the current status of trial NCT05376800?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2022-11-30. Estimated completion is 2025-07-31.
What interventions are being tested in trial NCT05376800?
The interventions under investigation include: BI 907828 (Brigimadlin) (DRUG).
Who is sponsoring clinical trial NCT05376800?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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