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Clinical Trial NCT06619509 for Solid Tumours is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine Phase 2 90
Clinical Trial NCT06619509 is designed to study Treatment for Solid Tumours. It is a Phase 2 interventional study that is active, not recruiting, having started on 30 December 2024, with plans to enroll 90 participants. Led by Boehringer Ingelheim, it is expected to complete by 30 December 2030. The latest data from ClinicalTrials.gov was last updated on 17 March 2026.
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 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...
Show MoreOfficial Title
A Phase II, Single-arm, Open-label, Long-term Safety Rollover Trial of Oral Brigimadlin in Patients With Solid Tumours
Conditions
Solid TumoursOther Study IDs
- 1403-0032
- 2024-514177-21-00 (Registry Identifier) (CTIS)
- U1111-1305-3484 (Registry Identifier) (WHO International Clinical Trials Registry Platform (ICTRP))
NCT ID Number
Start Date (Actual)
2024-12-30
Last Update Posted
2026-03-17
Completion Date (Estimated)
2030-12-30
Enrollment (Estimated)
90
Study Type
Interventional
PHASE
Phase 2
Status
Active, not recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalBrigimadlin | Brigimadlin Brigimadlin |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
The primary endpoint will be the occurrence of treatment-emergent adverse events (AEs) according to CTCAE Version 5.0 during the entire treatment period | CTCAE=Common Terminology Criteria for Adverse Events | up to 9 years. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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.
Boehringer IngelheimNo contact data.
50 Study Locations in 20 Countries
New South Wales
Prince of Wales Hospital-Randwick-66496, Randwick, New South Wales, 2031, Australia
Queensland
Princess Alexandra Hospital, Woolloongabba, Queensland, 4102, Australia
California
Precision NextGen Oncology, Beverly Hills, California, 90212, United States
Sarcoma Oncology Center, Santa Monica, California, 90403, United States
Connecticut
Yale Cancer Center, New Haven, Connecticut, 06511, United States
Florida
Mayo Clinic Cancer Center, Jacksonville, Florida, 32224, United States
Missouri
Washington University School of Medicine, St Louis, Missouri, 63108, United States
Nebraska
Nebraska Cancer Specialists-Omaha-69066, Omaha, Nebraska, 68130, United States
New York
Northwell Health, Lake Success, New York, 11042, United States
Tennessee
West Cancer Center & Research Institute, Germantown, Tennessee, 38138, United States
Henry-Joyce Cancer Clinic, Nashville, Tennessee, 37232, United States
Texas
The University of Texas MD Anderson Cancer Center, Houston, Texas, 77030, United States
Utah
Utah Cancer Specialists Cancer Center, Salt Lake City, Utah, 84106, United States
Washington
Fred Hutchinson Cancer Research Center, Seattle, Washington, 98109, United States
Wisconsin
University of Wisconsin, Madison, Wisconsin, 53792, United States
Sanatorio Finochietto, CABA, C1120AAB, Argentina
Cliniques Universitaires Saint-Luc, Brussels, 1200, Belgium
UZ Leuven, Leuven, 3000, Belgium
Alberta
Arthur J. E. Child Comprehensive Cancer Centre, Calgary, Alberta, T2N 5G2, Canada
Ontario
Princess Margaret Cancer Centre, Toronto, Ontario, M5G 2M9, Canada
Sun Yat-Sen University Cancer Center, Guangzhou, 510060, China
University Hospital Olomouc, Olomouc, 77900, Czechia
Copenhagen University Hospital, Rigshospitalet, København Ø, 2100, Denmark
CTR Leon Berard, Lyon, 69373, France
CTR Eugène Marquis, Rennes, 35042, France
Helios Klinikum Berlin-Buch, Berlin, 13125, Germany
Universitätsklinikum Tübingen, Tübingen, 72076, Germany
Clinexpert Gyongyos, Gyöngyös, 3200, Hungary
Sourasky Medical Center, Tel Aviv, 6423906, Israel
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, 20133, Italy
Istituto Oncologico Veneto IRCCS, Padua, 35128, Italy
National Hospital Organization Kyushu Cancer Center, Fukuoka, Fukuoka, 811-1395, Japan
Kyushu University Hospital, Fukuoka, Fukuoka, 812-8582, Japan
Kanagawa Cancer Center, Kanagawa, Yokohama, 241-8515, Japan
Tohoku University Hospital, Miyagi, Sendai, 980-8574, Japan
Okayama University Hospital, Okayama, Okayama, 700-8558, Japan
Osaka International Cancer Institute, Osaka, Osaka, 541-8567, Japan
National Cancer Center Hospital, Tokyo, Chuo-ku, 104-0045, Japan
Oslo Universitetssykehus HF, Radiumhospitalet, Oslo, N-0379, Norway
Oncology Center-Maria Sklodowska-Curie Institute, Warsaw, 02-781, Poland
Hospital Universitario Miguel Servet, Aragon, 50009, Spain
Fundación Jiménez Díaz, Madrid, 28040, Spain
Hospital Universitario 12 de Octubre, Madrid, 28041, Spain
Hospital Universitario HM Sanchinarro, Madrid, 28050, Spain
Hospital Clínico de Santiago, Santiago de Compostela, 15706, Spain
Karolinska Comprehensive Cancer Center, Stockholm, SE-171 76, Sweden
Taipei Veterans General Hospital, Taipei, 11217, Taiwan
Addenbrooke's Hospital, Cambridge, CB2 0QQ, United Kingdom
University College Hospital, London, NW12PQ, United Kingdom
The Royal Marsden Hospital, Chelsea, London, SW3 6JJ, United Kingdom