Spots Global Cancer Trial Database for Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma
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Trial Identification
Brief Title: Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma
Official Title: Brightline-1: A Phase II/III, Randomized, Open-label, Multi-center Study of Brigimadlin (BI 907828) Compared to Doxorubicin as First Line Treatment of Patients With Advanced Dedifferentiated Liposarcoma
Study ID: NCT05218499
Conditions
Study Description
Brief Summary: This study is open to people with a type of cancer called dedifferentiated liposarcoma. People with advanced liposarcoma aged 18 or older who are not receiving any other cancer treatment can participate. The purpose of this study is to compare a medicine called brigimadlin (BI 907828) with doxorubicin in people with liposarcoma. Brigimadlin (BI 907828) is a so-called MDM2 inhibitor that is being developed to treat cancer. Doxorubicin is a medicine already used to treat cancer including liposarcoma. During the study, participants get either brigimadlin (BI 907828) or doxorubicin. Every 3 weeks, participants take brigimadlin (BI 907828) as tablets or doxorubicin as an infusion into a vein. Participants can switch to brigimadlin (BI 907828) treatment if they did not benefit from doxorubicin treatment. Participants can continue treatment in the study as long as they benefit from it and can tolerate it. Doctors regularly check the size of the tumour and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.
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
University of Arizona, Tucson, Arizona, United States
Precision NextGen Oncology, Beverly Hills, California, United States
City of Hope, Duarte, California, United States
University of Southern California, Los Angeles, California, United States
Sarcoma Oncology Center, Santa Monica, California, United States
Mayo Clinic Cancer Center, Jacksonville, Florida, United States
Winship Cancer Institute, Atlanta, Georgia, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan Health System, Ann Arbor, Michigan, United States
Mayo Clinic, Rochester, Rochester, Minnesota, United States
Barnes-Jewish Hospital, Saint Louis, Missouri, United States
Nebraska Cancer Specialists, Omaha, Nebraska, United States
University Hospitals of Cleveland, Cleveland, Ohio, United States
Oregon Health and Sciences University, Portland, Oregon, United States
Henry-Joyce Cancer Clinic, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Froedtert and The Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Prince of Wales Hospital, Randwick, New South Wales, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Ashford Cancer Centre Research, Kurralta Park, South Australia, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
UZ Leuven, Leuven, , Belgium
BC Cancer Agency - Vancouver, Vancouver, British Columbia, Canada
The Ottawa Hospital, Ottawa, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada
Cancer Hospital of Chinese Academy of Medical Science, Beijing, , China
Beijing Cancer Hospital, Beijing, , China
The First Hospital of Jilin University, Changchun, , China
West China Hospital, Chengdu, , China
Sun Yat-Sen University Cancer Center, Guangzhou, , China
Harbin Medical University cancer hospital, Haerbin, , China
Zhejiang Cancer Hospital, Hangzhou, , China
Zhongshan Hospital Fudan University, Shanghai, , China
Wuhan Union Hospital, Wuhan, , China
Masaryk Memorial Cancer Institute, Brno, , Czechia
University Hospital Olomouc, Olomouc, , Czechia
University Hospital Motol, Prague 5, , Czechia
Herlev and Gentofte Hospital, Herlev, , Denmark
HUCH Comprehensive Cancer Center, building 2, Helsinki, , Finland
Tampere University Hospital, Tampere, , Finland
INS Bergonie, Bordeaux, , France
CTR Oscar Lambret, Lille, , France
CTR Leon Berard, Lyon, , France
HOP Timone, Marseille, , France
HOP Cochin, Paris, , France
CTR Eugène Marquis, Rennes, , France
INS Claudius Regaud IUCT-Oncopole, Toulouse, , France
INS Gustave Roussy, Villejuif, , France
Helios Klinikum Bad Saarow, Bad Saarow, , Germany
Helios Klinikum Berlin-Buch, Berlin, , Germany
Universitätsklinikum Carl Gustav Carus Dresden, Dresden, , Germany
Universitätsklinikum Essen AöR, Essen, , Germany
Asklepios Kliniken GmbH & Co. KGaA, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Universitätsklinikum Mannheim GmbH, Mannheim, , Germany
Klinikum der Universität München AÖR, München, , Germany
Robert Bosch Gesellschaft für medizinische Forschung mbH, Stuttgart, , Germany
Hippokration General Hospital of Athen, Athens, , Greece
"Attikon" University General Hospital of Attica, Haidari, , Greece
Bioclinic Thessaloniki, Thessaloniki, , Greece
Prince of Wales Hospital, Hong Kong, , Hong Kong
Humanitas Gavazzeni, Bergamo, , Italy
Istituto Di Candiolo, Candiolo (TO), , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Istituto Nazionale IRCCS Tumori Fondazione Pascale, Napoli, , Italy
AOU San Luigi Gonzaga, Orbassano (TO), , Italy
Istituto Oncologico Veneto IRCCS, Padova, , Italy
A.O. Univ. Policlinico Giaccone, Palermo, , Italy
Università Campus Bio-Medico - ROMA, Roma, , Italy
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
National Cancer Center Hospital, Tokyo, Chuo-ku, , Japan
Japanese Foundation for Cancer Research, Tokyo, Koto-ku, , Japan
Nederlands Kanker Instituut, Amsterdam, , Netherlands
Leids Universitair Medisch Centrum (LUMC), Leiden, , Netherlands
Oslo Universitetssykehus HF, Radiumhospitalet, Oslo, , Norway
IPO Lisboa Francisco Gentil, EPE, Lisboa, , Portugal
ULS de Santa Maria, E.P.E, Lisboa, , Portugal
Hospital Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Vall d'Hebron, Barcelona, , Spain
Hospital Duran i Reynals, L'Hospitalet de Llobregat, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Fundación Jiménez Díaz, Madrid, , Spain
Hospital La Paz, Madrid, , Spain
Hospital Universitario HM Sanchinarro, Madrid, , Spain
Hospital Virgen de la Victoria, Malaga, , Spain
Hospital Clínico de Santiago, Santiago de Compostela, , Spain
Hospital Miguel Servet, Zaragoza, , Spain
Skånes universitetssjukhus, Lund, , Sweden
Karolinska Universitetssjukhuset Stockholm, Stockholm, , Sweden
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Addenbrooke's Hospital, Cambridge, , United Kingdom
Churchill Hospital, Headington, , United Kingdom
University College Hospital, London, , United Kingdom
The Royal Marsden Hospital, Chelsea, London, , United Kingdom
Contact Details
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