Brigimadlin for Cancer
Trial Summary
What is the purpose of this trial?
This study is open to adults who participated in a previous clinical study with brigimadlin. The goal of this study is to find out how well people with solid tumours tolerate long-term treatment with brigimadlin. Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer. Participants are grouped in cohorts depending on their treatment in the previous study: * Cohort 1a got brigimadlin and continues treatment with brigimadlin * Cohort 1b got brigimadlin for 4 or less treatment cycles; each cycle was 3 weeks long * Cohort 2 received a comparator and gets brigimadlin for the first time All participants take brigimadlin as tablets once every 3 weeks at the study site. Participants in the Cohorts 1b and 2 visit the sites more frequently. At study visits, doctors check participants' health and take note of any unwanted effects. At some study visits, doctors also check the size of the tumour and whether it has spread to other parts of the body. Participants are in the study as long as they benefit from treatment and can tolerate it.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it mentions that participants should not receive restricted medications or any drug that might interfere with the trial. It's best to discuss your current medications with the trial team to see if they are allowed.
Eligibility Criteria
Adults with solid tumors who were in a previous brigimadlin study can join. They must be able to continue treatment, have signed consent, use effective birth control, and follow the trial's procedures. Their organs must work well and any past treatment side effects should be mild.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take brigimadlin as tablets once every 3 weeks at the study site. Health checks and monitoring for adverse effects are conducted.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants continue long-term treatment with brigimadlin as long as they benefit and can tolerate it
Treatment Details
Interventions
- Brigimadlin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boehringer Ingelheim
Lead Sponsor