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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05512377
Other study ID # 1403-0011
Secondary ID 2023-506369-79-0
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 25, 2022
Est. completion date March 25, 2027

Study information

Verified date June 2024
Source Boehringer Ingelheim
Contact Boehringer Ingelheim
Phone 1-800-243-0127
Email clintriage.rdg@boehringer-ingelheim.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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Study Design


Intervention

Drug:
brigimadlin
brigimadlin

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Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  France,  Germany,  Japan,  Korea, Republic of,  Singapore,  South Africa,  Spain,  Switzerland,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 30 months
Secondary 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. Up to 30 months
Secondary 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. Up to 30 months
Secondary Overall survival (OS) OS is defined as the time from treatment start until death from any cause. Up to 50 months
Secondary 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. Up to 30 months
Secondary Occurrence of treatment-emergent adverse events (AEs) during the on-treatment period Up to 30 months
Secondary Occurrence of treatment-emergent AEs leading to trial drug discontinuation during the on-treatment period Up to 30 months
Secondary 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. Up to 30 months
Secondary 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) Up to 30 months
Secondary 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) Up to 30 months
Secondary 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. Up to 30 months
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