Spots Global Cancer Trial Database for Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder
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Trial Identification
Brief Title: Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder
Official Title: Brightline-2: A Phase IIa/IIb, Open-label, Single-arm, Multi-centre Trial of Brigimadlin (BI 907828) for Treatment of Patients With Locally Advanced / Metastatic, MDM2 Amplified, TP53 Wild-type Biliary Tract Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, or Other Selected Solid Tumours
Study ID: NCT05512377
Interventions
Study Description
Brief Summary: This study is open to adults with advanced cancer in the biliary tract, pancreas, lung, or bladder. This is a study for people for whom previous treatment was not successful or no treatment exists. The purpose of this study is to find out whether a medicine called BI 907828 helps people with cancer in the biliary tract, pancreas, lung, or bladder. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. All participants take BI 907828 as a tablet once every 3 weeks. Participants may continue to take BI 907828 as long as they benefit from treatment and can tolerate it. They visit the study site regularly. At the study site, doctors regularly check the size of the tumour and 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
Southern Cancer Center, Mobile, Alabama, United States
University of Arizona, Tucson, Arizona, United States
Precision NextGen Oncology, Beverly Hills, California, United States
University of Southern California, Los Angeles, California, United States
Stanford Cancer Institute, Palo Alto, California, United States
Providence Medical Foundation, Santa Rosa, California, United States
Rocky Mountain Cancer Centers, Lone Tree, Colorado, United States
Johns Hopkins Sidney Kimmel Cancer Center at Sibley Memorial Hospital, Washington, District of Columbia, United States
Norton Cancer Institute, Downtown, Louisville, Kentucky, United States
University of Michigan Health System, Ann Arbor, Michigan, United States
Nebraska Cancer Specialists, Omaha, Nebraska, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island, Mineola, New York, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Cleveland Clinic, Cleveland, Ohio, United States
Oregon Health and Sciences University, Portland, Oregon, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
University of Wisconsin, Madison, Wisconsin, United States
Prince of Wales Hospital, Randwick, New South Wales, Australia
ICON, South Brisbane, Queensland, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
Austin Health, Heidelberg, Victoria, Australia
LK Wiener Neustadt, Wiener Neustadt, , Austria
Edegem - UNIV UZ Antwerpen, Edegem, , Belgium
UNIV UZ Gent, Gent, , Belgium
INS Bergonie, Bordeaux, , France
HOP Beaujon, Clichy, , France
CTR Georges-François Leclerc, Dijon, , France
HOP Edouard Herriot, Lyon, , France
INS Gustave Roussy, Villejuif, , France
Universitätsklinikum Carl Gustav Carus Dresden, Dresden, , Germany
Krankenhaus Nordwest, Frankfurt, Frankfurt, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Klinikum der Universität München - Campus Großhadern, München, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
National Cancer Center Hospital East, Chiba, Kashiwa, , Japan
Kanagawa Cancer Center, Kanagawa, Yokohama, , Japan
Tohoku University Hospital, Miyagi, Sendai, , Japan
Osaka International Cancer Institute, Osaka, Osaka, , Japan
National Cancer Center Hospital, Tokyo, Chuo-ku, , Japan
Japanese Foundation for Cancer Research, Tokyo, Koto-ku, , Japan
Yamaguchi University Hospital, Yamaguchi, Ube, , Japan
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
National University Hospital, Singapore, , Singapore
Hospital Vall d'Hebron, Barcelona, , Spain
Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Clínico de Valencia, Valencia, , Spain
University Hospital Bern/Inselspital Bern, Bern, , Switzerland
University Hospital Geneva, Genève 14, , Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Taiwan University Cancer Center, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Chulabhorn Hospital, Bangkok, , Thailand
Maharaj Nakom Chiangmai Hospital, Chiang Mai, , Thailand
Songklanagarind Hospital, Hat Yai, , Thailand
Srinagarind Hospital, Muang, , Thailand
University College Hospital, London, , United Kingdom
Contact Details
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