Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-514177-21-00 | Registry Identifier | CTIS | |
| U1111-1305-3484 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brigimadlin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brigimadlin | Drug | Brigimadlin |
|
|
| 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. |
Not provided
Not provided
Inclusion criteria:
Exclusion criteria:
Further exclusion criteria apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Precision NextGen Oncology | Beverly Hills | California | 90212 | United States | ||
| Sarcoma Oncology Center |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
For study documents -upon signing of a 'Document Sharing Agreement'. For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Not provided
Not provided
Not provided
Not provided
Not provided
| Santa Monica |
| California |
| 90403 |
| United States |
| Yale Cancer Center | New Haven | Connecticut | 06511 | United States |
| Mayo Clinic Cancer Center | Jacksonville | Florida | 32224 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63108 | United States |
| Nebraska Cancer Specialists-Omaha-69066 | Omaha | Nebraska | 68130 | United States |
| Northwell Health | Lake Success | New York | 11042 | United States |
| West Cancer Center & Research Institute | Germantown | Tennessee | 38138 | United States |
| Henry-Joyce Cancer Clinic | Nashville | Tennessee | 37232 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Utah Cancer Specialists Cancer Center | Salt Lake City | Utah | 84106 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| Sanatorio Finochietto | CABA | C1120AAB | Argentina |
| Prince of Wales Hospital-Randwick-66496 | Randwick | New South Wales | 2031 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Arthur J. E. Child Comprehensive Cancer Centre | Calgary | Alberta | T2N 5G2 | Canada |
| 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 | Padova | 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 |
| ID | Term |
|---|---|
| C000712508 | brigimadlin |
Not provided
Not provided
Not provided