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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
99
brigimadlin
Southern Cancer Center
Mobile, Alabama, United States
University of Arizona
Tucson, Arizona, United States
University of Southern California
Los Angeles, California, United States
Stanford Cancer Institute
Palo Alto, California, United States
Providence Medical Foundation-Santa Rosa -69764
Santa Rosa, California, United States
Objective response (OR)
OR is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1.
Time frame: Up to 30 months
Duration of objective response (DOR)
DOR is defined as the time from first documented confirmed objective response (OR) until the earliest date of disease progression or death among patients with confirmed objective response.
Time frame: Up to 30 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 or death from any cause, whichever occurs first.
Time frame: Up to 30 months
Overall survival (OS)
OS is defined as the time from treatment start until death from any cause.
Time frame: Up to 50 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.
Time frame: Up to 30 months
Occurrence of treatment-emergent adverse events (AEs) during the on-treatment period
Time frame: Up to 30 months
Occurrence of treatment-emergent AEs leading to trial drug discontinuation during the on-treatment period
Time frame: Up to 30 months
Change from baseline in European Organisation for Research and Treatment (EORTC) Quality of Life Questionnaire (QLQ)-C30 physical functioning domain score
The QLQ-C30 comprises 30 questions. The QLQ-C30 incorporates both multi-items scales and single-item measures. These include 1 global health status/QoL scale, 5 functional scales, 3 symptoms scales and 6 single items to assess dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function, symptoms and financial difficulties and 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life.
Time frame: Up to 30 months
Change from baseline in EORTC QLQ-C30 fatigue domain score
It is part of QLQ-C30 and uses 4-point scale (1=not at all to 4=very much)
Time frame: Up to 30 months
Change from baseline in EORTC QLQ-C30 role functioning domain score
It is part of QLQ-C30 and uses 4-point scale (1=not at all to 4=very much)
Time frame: Up to 30 months
Change from baseline in EORTC QLQ-BIL21 tiredness domain score
The QLQ-BIL21 is specific for the assessment of quality of life in patients with cholangiocarcinoma and cancer of the gallbladder. It consists of 21 questions with a 4-point scale (1=not at all to 4=very much), and the tiredness domain is part of it.
Time frame: Up to 30 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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