Study on Long-term Treatment with Brigimadlin for People with Solid Tumors from a Previous Study
Sponsor: Boehringer Ingelheim
ClinicalTrials ID:NCT06619509
This study is for adults who have already participated in a previous study with the cancer treatment brigimadlin. It aims to see how well patients with solid tumors can handle long-term treatment with this medication.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to understand how well people with solid tumors can tolerate long-term treatment with brigimadlin, a medication being developed to treat cancer. Participants are divided into groups based on their previous treatment with brigimadlin. Some continue their treatment, while others start brigimadlin for the first time. All participants take brigimadlin tablets every three weeks at the study site. Doctors will monitor their health, check for any side effects, and assess the size and spread of the tumor. Participants stay in the study as long as they benefit from the treatment and can tolerate it.
Eligibility Criteria
Inclusion Criteria
- Currently taking brigimadlin or eligible to switch to brigimadlin from another study.
- Must provide written consent to participate.
- Women who can have children and men who can father children must use two reliable birth control methods during the study and for a specified time after the last dose.
- Willing to follow the study schedule, treatment plan, and other procedures.
- Have good organ function.
- Any side effects from previous cancer treatments must be mild or resolved, except for hair loss and menstrual issues, which can be any level, and mild nerve damage.
Cohort 1 only:
- Eligible to continue treatment as per the original study protocol. If experiencing a delay due to side effects, must recover within the allowed time.
Cohort 2 only:
- Eligible to switch to brigimadlin as per the original study protocol, with no other cancer treatments in between, unless allowed by the original study.
Exclusion Criteria
- Any medical condition that the doctor believes should prevent treatment with brigimadlin.
- Need to take medications that could interfere with the study.
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study.
Cohort 1 only:
- Disease has worsened or side effects are unacceptable at the time of joining this study.
- Side effects causing a delay in treatment have not improved within the allowed time.
- Already had two dose reductions and need a third, unless agreed upon by the doctor and sponsor.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Precision NextGen Oncology | 90212 | Beverly Hills | California |
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