Active, Not Recruiting
A Phase II, Single-arm, Open-label, Long-term Safety Rollover Trial of Oral Brigimadlin in Patients With Solid Tumours
Led by Boehringer Ingelheim · Updated on 2026-04-14
90
Participants Needed
50
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine
Who Can Participate
Eligibility Criteria
You may qualify if you...
Inclusion criteria:
- 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 criteria:
- 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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 50 locations
1
Precision NextGen Oncology
Beverly Hills, California, United States, 90212
Status Unknown
2
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
Status Unknown
3
Yale Cancer Center
New Haven, Connecticut, United States, 06511
Status Unknown
4
Mayo Clinic Cancer Center
Jacksonville, Florida, United States, 32224
Status Unknown
5
Washington University School of Medicine
St Louis, Missouri, United States, 63108
Status Unknown
6
Nebraska Cancer Specialists-Omaha-69066
Omaha, Nebraska, United States, 68130
Status Unknown
7
Northwell Health
Lake Success, New York, United States, 11042
Status Unknown
8
West Cancer Center & Research Institute
Germantown, Tennessee, United States, 38138
Status Unknown
9
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States, 37232
Status Unknown
10
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Status Unknown
11
Utah Cancer Specialists Cancer Center
Salt Lake City, Utah, United States, 84106
Status Unknown
12
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Status Unknown
13
University of Wisconsin
Madison, Wisconsin, United States, 53792
Status Unknown
14
Sanatorio Finochietto
CABA, Argentina, C1120AAB
Status Unknown
15
Prince of Wales Hospital-Randwick-66496
Randwick, New South Wales, Australia, 2031
Status Unknown
16
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Status Unknown
17
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Status Unknown
18
UZ Leuven
Leuven, Belgium, 3000
Status Unknown
19
Arthur J. E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T2N 5G2
Status Unknown
20
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Status Unknown
21
Sun Yat-Sen University Cancer Center
Guangzhou, China, 510060
Status Unknown
22
University Hospital Olomouc
Olomouc, Czechia, 77900
Status Unknown
23
Copenhagen University Hospital, Rigshospitalet
København Ø, Denmark, 2100
Status Unknown
24
CTR Leon Berard
Lyon, France, 69373
Status Unknown
25
CTR Eugène Marquis
Rennes, France, 35042
Status Unknown
26
Helios Klinikum Berlin-Buch
Berlin, Germany, 13125
Status Unknown
27
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Status Unknown
28
Clinexpert Gyongyos
Gyöngyös, Hungary, 3200
Status Unknown
29
Sourasky Medical Center
Tel Aviv, Israel, 6423906
Status Unknown
30
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Status Unknown
31
Istituto Oncologico Veneto IRCCS
Padova, Italy, 35128
Status Unknown
32
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, Japan, 811-1395
Status Unknown
33
Kyushu University Hospital
Fukuoka, Fukuoka, Japan, 812-8582
Status Unknown
34
Kanagawa Cancer Center
Kanagawa, Yokohama, Japan, 241-8515
Status Unknown
35
Tohoku University Hospital
Miyagi, Sendai, Japan, 980-8574
Status Unknown
36
Okayama University Hospital
Okayama, Okayama, Japan, 700-8558
Status Unknown
37
Osaka International Cancer Institute
Osaka, Osaka, Japan, 541-8567
Status Unknown
38
National Cancer Center Hospital
Tokyo, Chuo-ku, Japan, 104-0045
Status Unknown
39
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo, Norway, N-0379
Status Unknown
40
Oncology Center-Maria Sklodowska-Curie Institute
Warsaw, Poland, 02-781
Status Unknown
41
Hospital Universitario Miguel Servet
Aragon, Spain, 50009
Status Unknown
42
Fundación Jiménez Díaz
Madrid, Spain, 28040
Status Unknown
43
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Status Unknown
44
Hospital Universitario HM Sanchinarro
Madrid, Spain, 28050
Status Unknown
45
Hospital Clínico de Santiago
Santiago de Compostela, Spain, 15706
Status Unknown
46
Karolinska Comprehensive Cancer Center
Stockholm, Sweden, SE-171 76
Status Unknown
47
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Status Unknown
48
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Status Unknown
49
University College Hospital
London, United Kingdom, NW12PQ
Status Unknown
50
The Royal Marsden Hospital, London
London, United Kingdom, SW3 6JJ
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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