Status:
ACTIVE_NOT_RECRUITING
A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Solid Tumours
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is open to adults with solid tumours who received at least 4 cycles of treatment with brigimadlin in a previous study. The goal of this study is to find out how well people with solid tumou...
Eligibility Criteria
Inclusion
- Patient is ongoing on brigimadlin treatment in any trial sponsored by Boehringer Ingelheim (hereafter referred to as the 'parent trial').
- Provision of signed and dated, written informed consent form (ICF) in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.
- Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use 2 medically acceptable methods of birth control per ICH M3 (R2) that result in a low failure rate of \<1% per year when used consistently and correctly beginning at Screening, during trial participation, and until 6 months and 12 days after the last dose for women and 102 days after the last dose for men. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information.
- Participants must be willing and able to comply with the scheduled visits, treatment plan, lifestyle, laboratory tests, contraceptive guidelines, and other study procedures.
- Adequate organ function.
- Patient is eligible to receive continued treatment according to the clinical trial protocol of the parent trial they are currently participating in. Patients currently experiencing a dose delay in the parent trial due to adverse events are eligible if recovery from the adverse event takes place within the allowed time window in the parent trial.
Exclusion
- Any medical condition which in the opinion of the investigator should exclude the patient from receiving treatment with brigimadlin.
- Participants who must receive or intend to receive restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Female patients who do not agree to the interruption of breastfeeding from the start of study treatment until 6 months and 12 days after the last dose of study treatment.
- Patient has unacceptable toxicity on brigimadlin at the time of transition into this trial.
- Patient has an adverse event (AE) which has caused a dose delay and has not recovered within the allowed time window in the parent trial.
- Patient who has already required 2 dose reductions and would require a third dose reduction at trial entry, unless the investigator deems treatment continuation beneficial, and the third dose reduction is agreed in writing between the investigator and the sponsor.
- Further exclusion criteria apply.
Key Trial Info
Start Date :
December 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2030
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06619509
Start Date
December 30 2024
End Date
December 30 2030
Last Update
March 6 2026
Active Locations (50)
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1
Precision NextGen Oncology
Beverly Hills, California, United States, 90212
2
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
3
Yale Cancer Center
New Haven, Connecticut, United States, 06511
4
Mayo Clinic Cancer Center
Jacksonville, Florida, United States, 32224