The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
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
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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