A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine
Condition(s) studied
Investigational drug(s) / intervention(s)
Brigimadlin: Brigimadlin
Study 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 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
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.
More Boehringer Ingelheim trials in Italy
Other trials for the same condition
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.
View NCT06619509 on ClinicalTrials.gov ↗ ← All trials in Italy