A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine
- Registration Number
- NCT06619509
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This study is open to adults who participated in a previous clinical study with brigimadlin.
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 is being developed to treat cancer.
Participants are grouped in cohorts depending on their treatment in the previous study:
* Cohort 1a got brigimadlin and continues treatment with brigimadlin
* Cohort 1b got brigimadlin for 4 or less treatment cycles; each cycle was 3 weeks long
* Cohort 2 received a comparator and gets brigimadlin for the first time
All participants take brigimadlin as tablets once every 3 weeks at the study site. Participants in the Cohorts 1b and 2 visit the sites more frequently. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Brigimadlin Brigimadlin -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (56)
Clinexpert Gyongyos
ðŸ‡ðŸ‡ºGyongyos, Hungary
Okayama University Hospital
🇯🇵Okayama, Okayama, Japan
Universitätsklinikum Frankfurt
🇩🇪Frankfurt, Germany
Sourasky Medical Center
🇮🇱Tel-Aviv, Israel
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Precision NextGen Oncology
🇺🇸Beverly Hills, California, United States
Sarcoma Oncology Center
🇺🇸Santa Monica, California, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Mayo Clinic Cancer Center
🇺🇸Jacksonville, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Nebraska Cancer Specialists-Omaha-69066
🇺🇸Omaha, Nebraska, United States
Northwell Health
🇺🇸Lake Success, New York, United States
West Cancer Center & Research Institute
🇺🇸Germantown, Tennessee, United States
Henry-Joyce Cancer Clinic
🇺🇸Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Utah Cancer Specialists Cancer Center
🇺🇸Salt Lake City, Utah, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Sanatorio Finochietto
🇦🇷Caba, Argentina
Prince of Wales Hospital-Randwick-66496
🇦🇺Randwick, New South Wales, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Brussels - UNIV Saint-Luc
🇧🇪Bruxelles, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
H.S.J. Beneficência Portuguesa - São Paulo
🇧🇷Sao Paulo, Brazil
West China Hospital
🇨🇳Chengdu, China
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
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milano, Italy
Istituto Nazionale IRCCS Tumori Fondazione Pascale
🇮🇹Napoli, 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
Osaka International Cancer Institute
🇯🇵Osaka, Osaka, Japan
National Cancer Center Hospital
🇯🇵Tokyo, Chuo-ku, Japan
Nederlands Kanker Instituut
🇳🇱Amsterdam, Netherlands
Oslo Universitetssykehus HF, Radiumhospitalet
🇳🇴Oslo, Norway
Oncology Center-Maria Sklodowska-Curie Institute
🇵🇱Warsaw, Poland
Hospital Miguel Servet
🇪🇸Aragon, Spain
Fundación Jiménez DÃaz
🇪🇸Madrid, Spain
Hospital ClÃnico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario HM Sanchinarro
🇪🇸Madrid, Spain
Hospital ClÃnico de Santiago
🇪🇸Santiago de Compostela, Spain
Karolinska Comprehensive Cancer Center
🇸🇪Stockholm, Sweden
University Hospital Bern/Inselspital Bern
🇨ðŸ‡Bern, Switzerland
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
The Royal Marsden Hospital, Chelsea
🇬🇧London, United Kingdom