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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504522-19-00 | Registry Identifier | CTIS |
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This study is open to adults with a type of cancer called dedifferentiated liposarcoma (DDLPS). They can join the study if their tumours are positive for MDM2. The purpose of this study is to find out whether a medicine called brigimadlin (BI 907828) is tolerated by and helps people with DDLPS. Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer.
Participants take brigimadlin as a tablet once every 3 weeks. Participants may continue to take brigimadlin as long as they benefit from treatment and can tolerate it. They visit the study site regularly. At the study site, doctors regularly check participants' health and take note of any unwanted effects. The doctors also regularly check tumour size.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brigimadlin treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brigimadlin | Drug | Brigimadlin |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Treatment-emergent adverse events (TEAEs) according to Common Terminology Criteria for Adverse Events (CTCAE) version 5 during the entire treatment period | up to 23 months | |
| Occurrence of TEAEs with Grade ≥3 according to CTCAE version 5 during the entire treatment period | up to 23 months |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of treatment-emergent serious adverse events (SAEs) | up to 23 months | |
| Occurrence of TEAEs leading to study treatment discontinuation | up to 23 months | |
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Inclusion Criteria:
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 (ICH) - Good Clinical Practice (GCP) and local legislation prior to any study-specific procedures, sampling, or analyses
Male or female patients ≥18 years old at the time of signature of the ICF
Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use two 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 study participation, and until 6 months and 12 days after last dose for women and 102 days after last dose for men. A list of contraception methods meeting these criteria is provided in the patient information
Histologically documented locally advanced or metastatic, unresectable (i.e. surgery morbidity would outweigh potential benefits), progressive or recurrent Dedifferentiated liposarcoma (DDLPS), meeting the criteria for an open study cohort:
Written pathology report indicating the diagnosis of DDLPS with positive MDM2 immunohistochemistry or MDM2 amplification as demonstrated by fluorescence in situ hybridisation (FISH) or next-generation sequencing (NGS)
Presence of at least 1 measurable target lesion according to RECIST version 1.1. In patients who only have 1 target lesion, the baseline imaging must be performed at least 2 weeks after any biopsy of the target lesion
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy ≥3 months at the start of treatment in the opinion of the investigator Further inclusion criteria apply.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States | ||
| Mayo Clinic-Arizona |
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| Label | URL |
|---|---|
| Related Info | View source |
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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.
After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
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.
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| Occurrence of TEAEs leading to dose reduction |
| up to 23 months |
| Occurrence of TEAEs leading to dose delay | up to 23 months |
| Occurrence of TEAEs of special interest (adverse events of special interest [AESIs]) | up to 23 months |
| Objective response (OR) | OR is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (based on investigator assessment) from the date of treatment start until the earliest date of disease progression, death, last evaluable tumour assessment before start of subsequent anticancer therapy, lost to follow-up, withdrawal of consent or end of study (EoS) | up to 23 months |
| Progression-free survival (PFS) | PFS is defined as the time from treatment start until the earliest date of tumour progression according to RECIST version 1.1, based on investigator assessment, or death from any cause | up to 23 months |
| Overall survival (OS) | OS is defined as the time from treatment start until death from any cause | up to 23 months |
| Duration of objective response (DOR) | DOR is defined as the time from first documented confirmed OR until the earliest date of disease progression or death among patients with confirmed OR (based on investigator assessment) | up to 23 months |
| Disease control (DC) | DC is defined as a best overall response of CR, PR, or stable disease (SD) where best overall response is defined according to RECIST version 1.1 based on investigator assessment | up to 23 months |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Precision NextGen Oncology | Beverly Hills | California | 90212 | United States |
| Sarcoma Oncology Center | Santa Monica | California | 90403 | United States |
| University of California Los Angeles | Santa Monica | California | 90404 | United States |
| Yale Cancer Center | New Haven | Connecticut | 06510 | United States |
| Mayo Clinic - Florida | Jacksonville | Florida | 32224 | United States |
| University Cancer and Blood Center | Athens | Georgia | 30607 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Kansas Cancer Center | Overland Park | Kansas | 66210 | United States |
| Mayo Clinic, Rochester | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63108 | United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| John Theurer Cancer Center | Hackensack | New Jersey | 07601 | United States |
| Northwell Health | Lake Success | New York | 11042 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Abramson Cancer Center at Pennsylvania Hospital | Philadelphia | Pennsylvania | 19106 | United States |
| West Cancer Center & Research Institute | Germantown | Tennessee | 38138 | 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 |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| Medical Oncology Associates, P.S. | Spokane | Washington | 99208 | United States |
| Froedtert and The Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Hospital Britanico de Buenos Aires | CABA | 1280AEB | Argentina |
| Sanatorio Finochietto | CABA | C1120AAB | Argentina |
| Hospital Italiano de Buenos Aires | CABA | C1199ABB | Argentina |
| Instituto Medico Especializado Alexander Fleming | Ciudad Autonoma de Bs As | C1426ANZ | Argentina |
| Prince of Wales Hospital-Randwick-66496 | Randwick | New South Wales | 2031 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| Pronutrir | Fortaleza | 60810-180 | Brazil |
| Hospital do Cancer de Londrina | Londrina | 86015-520 | Brazil |
| CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia | Santo André | 09060-650 | Brazil |
| Hospital Sao Domingos | São Luís | 65060-645 | Brazil |
| H.S.J. Beneficência Portuguesa - São Paulo | São Paulo | 01323-001 | Brazil |
| Arthur J. E. Child Comprehensive Cancer Centre | Calgary | Alberta | T2N 5G2 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| McGill University Health Centre (MUHC) | Montreal | Quebec | H4A 3J1 | Canada |
| Aichi Cancer Center Hospital | Aichi, Nagoya | 464-8681 | Japan |
| Nagoya University Hospital | Aichi, Nagoya | 466-8560 | Japan |
| National Cancer Center Hospital East | Chiba, Kashiwa | 277-8577 | Japan |
| National Hospital Organization Kyushu Cancer Center | Fukuoka, Fukuoka | 811-1395 | Japan |
| Kyushu University Hospital | Fukuoka, Fukuoka | 812-8582 | 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 |
| Hokkaido Cancer Center | Sapporo, Hokkaido | 003-0804 | Japan |
| Japanese Foundation for Cancer Research | Tokyo, Koto-ku | 135-8550 | Japan |
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| Beatson West of Scotland Cancer Centre | Glasgow | G12 0YN | United Kingdom |
| The Royal Marsden Hospital, Chelsea | London | SW3 6JJ | United Kingdom |
| The Christie | Manchester | M20 4BX | United Kingdom |
| ID | Term |
|---|---|
| D008080 | Liposarcoma |
| ID | Term |
|---|---|
| D018205 | Neoplasms, Adipose Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |
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| ID | Term |
|---|---|
| C000712508 | brigimadlin |
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