1403-0019 - Brightline 4
Research type
Research Study
Full title
Brightline-4: A Phase III open-label, single-arm, multi-center study to assess the safety and efficacy of brigimadlin (BI 907828) treatment in patients with treatment-naïve or pre-treated advanced dedifferentiated liposarcoma
IRAS ID
1008814
Contact name
Medical Information
Contact email
Sponsor organisation
Boehringer Ingelheim Limited
Clinicaltrials.gov Identifier
Research summary
This study is open to adults with a type of cancer called dedifferentiated liposarcoma (DDLPS). They can join the study if their tumours are positive for MDM2. The purpose of this study is to find out whether a medicine called brigimadlin (BI 907828) is tolerated by and
helps people with DDLPS. Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer.
Participants take brigimadlin as a tablet once every 3 weeks. Participants may continue to take brigimadlin as long as they benefit from treatment and can tolerate it. They visit the study site regularly. At the study site, doctors regularly check participants’ health and take
note of any unwanted effects. The doctors also regularly check tumour size.REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0979
Date of REC Opinion
9 Jan 2024
REC opinion
Further Information Favourable Opinion