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 tumours tolerate long-term treatment with brigimadlin. Brigimadlin is a so-called MDM2 inhibitor that was being developed to treat cancer.
All participants take brigimadlin as tablets once every 3 weeks at the study site. 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria:
1. Patient is ongoing on brigimadlin treatment in any trial sponsored by Boehringer Ingelheim (hereafter referred to as the 'parent trial').
2. 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.
3. 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.
4. Participants must be willing and able to comply with the scheduled visits, treatment plan, lifestyle, laboratory tests, contraceptive guidelines, and other study procedures.
5. Adequate organ function.
6. 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 criteria:
1. Any medical condition which in the opinion of the investigator should exclude the patient from receiving treatment with brigimadlin.
2. Participants who must receive or intend to receive restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
3. 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.
4. Patient has unacceptable toxicity on brigimadlin at the time of transition into this trial.
5. 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.
6. 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.
Primary outcome measure(s)
The primary endpoint will be the occurrence of treatment-emergent adverse events (AEs) according to CTCAE Version 5.0 during the entire treatment period — up to 9 years. CTCAE=Common Terminology Criteria for Adverse Events
Trial sites (50)
Facility
City
Region
Status
Precision NextGen Oncology
Beverly Hills
California
Sarcoma Oncology Center
Santa Monica
California
Yale Cancer Center
New Haven
Connecticut
Mayo Clinic Cancer Center
Jacksonville
Florida
Washington University School of Medicine
St Louis
Missouri
Nebraska Cancer Specialists-Omaha-69066
Omaha
Nebraska
Northwell Health
Lake Success
New York
West Cancer Center & Research Institute
Germantown
Tennessee
Henry-Joyce Cancer Clinic
Nashville
Tennessee
The University of Texas MD Anderson Cancer Center
Houston
Texas
Utah Cancer Specialists Cancer Center
Salt Lake City
Utah
Fred Hutchinson Cancer Research Center
Seattle
Washington
University of Wisconsin
Madison
Wisconsin
Sanatorio Finochietto
CABA
Argentina
Prince of Wales Hospital-Randwick-66496
Randwick
New South Wales
Princess Alexandra Hospital
Woolloongabba
Queensland
Cliniques Universitaires Saint-Luc
Brussels
Belgium
UZ Leuven
Leuven
Belgium
Arthur J. E. Child Comprehensive Cancer Centre
Calgary
Alberta
Princess Margaret Cancer Centre
Toronto
Ontario
Sun Yat-Sen University Cancer Center
Guangzhou
China
University Hospital Olomouc
Olomouc
Czechia
Copenhagen University Hospital, Rigshospitalet
København Ø
Denmark
CTR Leon Berard
Lyon
France
CTR Eugène Marquis
Rennes
France
Helios Klinikum Berlin-Buch
Berlin
Germany
Universitätsklinikum Tübingen
Tübingen
Germany
Clinexpert Gyongyos
Gyöngyös
Hungary
Sourasky Medical Center
Tel Aviv
Israel
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
Italy
Istituto Oncologico Veneto IRCCS
Padova
Italy
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka
Japan
Kyushu University Hospital
Fukuoka, Fukuoka
Japan
Kanagawa Cancer Center
Kanagawa, Yokohama
Japan
Tohoku University Hospital
Miyagi, Sendai
Japan
Okayama University Hospital
Okayama, Okayama
Japan
Osaka International Cancer Institute
Osaka, Osaka
Japan
National Cancer Center Hospital
Tokyo, Chuo-ku
Japan
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo
Norway
Oncology Center-Maria Sklodowska-Curie Institute
Warsaw
Poland
+ 10 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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