Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma
Public ClinicalTrials.gov record NCT05218499. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Brightline-1: A Phase II/III, Randomized, Open-label, Multi-center Study of Brigimadlin (BI 907828) Compared to Doxorubicin as First Line Treatment of Patients With Advanced Dedifferentiated Liposarcoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is open to people with a type of cancer called dedifferentiated liposarcoma. People with advanced liposarcoma aged 18 or older who are not receiving any other cancer treatment can participate. The purpose of this study is to compare a medicine called brigimadlin (BI 907828) with doxorubicin in people with liposarcoma. Brigimadlin (BI 907828) is a so-called MDM2 inhibitor that is being developed to treat cancer. Doxorubicin is a medicine already used to treat cancer including liposarcoma. During the study, participants get either brigimadlin (BI 907828) or doxorubicin. Every 3 weeks, participants take brigimadlin (BI 907828) as tablets or doxorubicin as an infusion into a vein. Participants can switch to brigimadlin (BI 907828) treatment if they did not benefit from doxorubicin treatment. Participants can continue treatment in the study as long as they benefit from it and can tolerate it. Doctors regularly check the size of the tumour and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.
Study identification
- NCT ID
- NCT05218499
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 400 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2022 (Actual)
- Primary completion
- Apr 16, 2024 (Actual)
- Completion
- Jan 26, 2026 (Actual)
- Last update posted
- Mar 2, 2026
2022 – 2026
United States locations
- U.S. sites
- 20
- U.S. states
- 16
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| University of Arizona | Tucson | Arizona | 85719 | — |
| Precision NextGen Oncology | Beverly Hills | California | 90212 | — |
| City of Hope-Duarte-56419 | Duarte | California | 91010 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| Sarcoma Oncology Center | Santa Monica | California | 90403 | — |
| Mayo Clinic Cancer Center | Jacksonville | Florida | 32224 | — |
| Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | — |
| Mayo Clinic, Rochester | Rochester | Minnesota | 55905 | — |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | — |
| Nebraska Cancer Specialists-Omaha-69502 | Omaha | Nebraska | 68114 | — |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | — |
| Oregon Health and Sciences University | Portland | Oregon | 97239 | — |
| Henry-Joyce Cancer Clinic | Nashville | Tennessee | 37232 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
| Froedtert and The Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 89 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05218499, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 2, 2026 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05218499 live on ClinicalTrials.gov.