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NCT05218499 · ClinicalTrials.gov registry record · Phase 2
Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma
A Phase 2 study of Liposarcoma, Dedifferentiated, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 400
- Enrollment target
- 20
- Study locations
NCT05218499 is a Phase 2 study of Liposarcoma, Dedifferentiated that has completed, run by Boehringer Ingelheim. The registered enrollment target is 400 participants. The trial reports 20 study locations across 16 states.
The verdict
NCT05218499, a Phase 2 study of Liposarcoma, Dedifferentiated, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 400 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Doxorubicin
- DRUG Brigimadlin
Study Locations (20)
California
- Precision NextGen Oncology - Beverly Hills
- City of Hope-Duarte-56419 - Duarte
- University of Southern California - Los Angeles
- Sarcoma Oncology Center - Santa Monica
Massachusetts
- Massachusetts General Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- University of Arizona - Tucson
Florida
- Mayo Clinic Cancer Center - Jacksonville
Georgia
- Winship Cancer Institute - Atlanta
Michigan
- University of Michigan Health System - Ann Arbor
Minnesota
- Mayo Clinic, Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2022-03-31 |
| Est. Completion | 2026-01-26 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05218499
The ClinicalTrials.gov registry entry for NCT05218499 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 400 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 1 condition, with Liposarcoma, Dedifferentiated appearing as the primary indexed condition, and to 2 interventions - of which Doxorubicin is the first listed.
NCT05218499 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Massachusetts, Alabama.
Frequently Asked Questions
What is clinical trial NCT05218499 about?
NCT05218499 is a clinical study titled "Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma". 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 doxorubi...
What is the current status of trial NCT05218499?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 400 participants. The study started on 2022-03-31. Estimated completion is 2026-01-26.
What conditions does trial NCT05218499 study?
This clinical trial studies the following conditions: Liposarcoma, Dedifferentiated.
What interventions are being tested in trial NCT05218499?
The interventions under investigation include: Doxorubicin (DRUG), Brigimadlin (DRUG).
Who is sponsoring clinical trial NCT05218499?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05218499 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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