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Spots Global Cancer Trial Database for Brightline-4: A Study to Test How Well Brigimadlin is Tolerated by People With a Type of Cancer Called Dedifferentiated Liposarcoma

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Trial Identification

Brief Title: Brightline-4: A Study to Test How Well Brigimadlin is Tolerated by People With a Type of Cancer Called Dedifferentiated Liposarcoma

Official Title: Brightline-4: A Phase III Open-label, Single-arm, Multi-center Study to Assess the Safety and Efficacy of Brigimadlin (BI 907828) Treatment in Patients With Treatment-naïve or Pre-treated Advanced Dedifferentiated Liposarcoma

Study ID: NCT06058793

Interventions

Brigimadlin

Study Description

Brief Summary: 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.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Alabama at Birmingham, Birmingham, Alabama, United States

Mayo Clinic-Arizona, Phoenix, Arizona, United States

Precision NextGen Oncology, Beverly Hills, California, United States

Sarcoma Oncology Center, Santa Monica, California, United States

University of California Los Angeles, Santa Monica, California, United States

Yale Cancer Center, New Haven, Connecticut, United States

Mayo Clinic - Florida, Jacksonville, Florida, United States

University Cancer and Blood Center, Athens, Georgia, United States

Northwestern University, Chicago, Illinois, United States

University of Kansas Cancer Center, Overland Park, Kansas, United States

Mayo Clinic, Rochester, Rochester, Minnesota, United States

Nebraska Methodist Hospital, Omaha, Nebraska, United States

John Theurer Cancer Center, Hackensack, New Jersey, United States

Northwell Health, Lake Success, New York, United States

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Duke University Medical Center, Durham, North Carolina, United States

Abramson Cancer Center at Pennsylvania Hospital, Philadelphia, Pennsylvania, United States

West Cancer Center & Research Institute, Germantown, 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

Huntsman Cancer Institute, Salt Lake City, Utah, United States

Virginia Cancer Specialists, PC, Fairfax, Virginia, United States

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

Medical Oncology Associates, P.S., Spokane, Washington, United States

Froedtert and The Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Sanatorio Finochietto, Caba, , Argentina

Prince of Wales Hospital, Randwick, New South Wales, Australia

Princess Alexandra Hospital, Woolloongabba, Queensland, Australia

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia

Hospital do Cancer de Londrina, Londrina, , Brazil

CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia, Santo André, , Brazil

Hospital Sao Domingos, Sao Luis, , Brazil

H.S.J. Beneficência Portuguesa - São Paulo, Sao Paulo, , Brazil

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Aichi Cancer Center Hospital, Aichi, Nagoya, , Japan

Nagoya University Hospital, Aichi, Nagoya, , Japan

National Cancer Center Hospital East, Chiba, Kashiwa, , Japan

National Hospital Organization Kyushu Cancer Center, Fukuoka, Fukuoka, , Japan

Kyushu University Hospital, Fukuoka, Fukuoka, , Japan

Tohoku University Hospital, Miyagi, Sendai, , Japan

Okayama University Hospital, Okayama, Okayama, , Japan

Osaka International Cancer Institute, Osaka, Osaka, , Japan

Hokkaido Cancer Center, Sapporo, Hokkaido, , Japan

Japanese Foundation for Cancer Research, Tokyo, Koto-ku, , Japan

Addenbrooke's Hospital, Cambridge, , United Kingdom

Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom

The Royal Marsden Hospital, Chelsea, London, , United Kingdom

The Christie Hospital, Manchester, , United Kingdom

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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