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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
138
Brigimadlin
University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic-Arizona
Phoenix, Arizona, United States
Precision NextGen Oncology
Beverly Hills, California, United States
Sarcoma Oncology Center
Santa Monica, California, United States
University of California Los Angeles
Santa Monica, California, United States
Occurrence of Treatment-emergent adverse events (TEAEs) according to Common Terminology Criteria for Adverse Events (CTCAE) version 5 during the entire treatment period
Time frame: up to 23 months
Occurrence of TEAEs with Grade ≥3 according to CTCAE version 5 during the entire treatment period
Time frame: up to 23 months
Occurrence of treatment-emergent serious adverse events (SAEs)
Time frame: up to 23 months
Occurrence of TEAEs leading to study treatment discontinuation
Time frame: up to 23 months
Occurrence of TEAEs leading to dose reduction
Time frame: up to 23 months
Occurrence of TEAEs leading to dose delay
Time frame: up to 23 months
Occurrence of TEAEs of special interest (adverse events of special interest [AESIs])
Time frame: up to 23 months
Objective response (OR)
OR is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (based on investigator assessment) from the date of treatment start until the earliest date of disease progression, death, last evaluable tumour assessment before start of subsequent anticancer therapy, lost to follow-up, withdrawal of consent or end of study (EoS)
Time frame: up to 23 months
Progression-free survival (PFS)
PFS is defined as the time from treatment start until the earliest date of tumour progression according to RECIST version 1.1, based on investigator assessment, or death from any cause
Time frame: up to 23 months
Overall survival (OS)
OS is defined as the time from treatment start until death from any cause
Time frame: up to 23 months
Duration of objective response (DOR)
DOR is defined as the time from first documented confirmed OR until the earliest date of disease progression or death among patients with confirmed OR (based on investigator assessment)
Time frame: up to 23 months
Disease control (DC)
DC is defined as a best overall response of CR, PR, or stable disease (SD) where best overall response is defined according to RECIST version 1.1 based on investigator assessment
Time frame: up to 23 months
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...and 46 more locations