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NCT05512377 · ClinicalTrials.gov registry record · Phase 2
Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Terminated
- Registry status
- Phase 2
- Development phase
- 99
- Enrollment target
NCT05512377: Clinical Trial Phase 2 study, sponsored by Boehringer Ingelheim.
NCT05512377 is a Phase 2 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 99 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05512377, a Phase 2 study, was terminated before completion, sponsored by Boehringer Ingelheim.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 99 participants
- Enrollment target
Study Summary
This study is open to adults with advanced cancer in the biliary tract, pancreas, lung, or bladder. This is a study for people for whom previous treatment was not successful or no treatment exists. The purpose of this study is to find out whether a medicine called BI 907828 helps people with cancer in the biliary tract, pancreas, lung, or bladder. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. All participants take BI 907828 as a tablet once every 3 weeks. Participants may continue to take BI 907828 as long as they benefit from treatment and can tolerate it. They visit the study site regularly. At the study site, doctors regularly check the size of the tumour and whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.
Primary Outcome
OR is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1.
Interventions
- DRUG brigimadlin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2022-12-13 |
| Est. Completion | 2025-09-25 |
| Phase | Phase 2 |
Why NCT05512377 stopped before completion
NCT05512377 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 1 intervention - of which brigimadlin is the first listed.
NCT05512377 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05512377 about?
NCT05512377 is a clinical study titled "Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder". This study is open to adults with advanced cancer in the biliary tract, pancreas, lung, or bladder. This is a study for people for whom previous treatment was not successful or no treatment exists. The purpose of this study is to find out whether a medicine called BI 907828 helps people with cancer...
What is the current status of trial NCT05512377?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 99 participants. The study started on 2022-12-13. Estimated completion is 2025-09-25.
What interventions are being tested in trial NCT05512377?
The interventions under investigation include: brigimadlin (DRUG).
Who is sponsoring clinical trial NCT05512377?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05512377's enrollment target sits among peer trials
99 738th of 2000 higher than 1,258 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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