Spots Global Cancer Trial Database for A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib
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Trial Identification
Brief Title: A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib
Official Title: Brigatinib in Patients With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib
Study ID: NCT03535740
Conditions
Interventions
Study Description
Brief Summary: The primary purpose of this study is to determine the efficacy of brigatinib by confirmed objective response rate (ORR) by response evaluation criteria in solid tumors (Response Evaluation Criteria in Solid Tumors \[RECIST\]), in participants with ALK+ locally advanced or metastatic NSCLC whose disease has progressed on therapy with alectinib or ceritinib.
Detailed Description: The drug being tested in this study is called brigatinib (AP26113). Brigatinib is being tested to treat people who have anaplastic lymphoma kinase-positive (ALK+), advanced non-small-cell lung cancer (NSCLC). The study will enroll approximately 103 patients. Participants will be assigned to the treatment group: • Brigatinib All participants will be asked to take brigatinib 90 mg tablet in lead-in period for 7 days, followed by brigatinib 180 mg at the same time each day throughout the study. Participants with progressive disease had an option to receive an escalated dose of brigatinib 240 mg as per investigator's discretion in case no toxicities (greater than grade 2) are experienced. This multicenter trial will be conducted worldwide. The overall time to participate in this study is approximately 3 years. Participants will make multiple visits to the clinic, and 30 days after last dose of study drug for a follow-up assessment.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California Irvine Health Chao Family Comprehensive Cancer Center, Orange, California, United States
The Oncology Institute of Hope and Innovation, Whittier, California, United States
USOR - Rocky Mountain Cancer Centers - Pueblo, Pueblo, Colorado, United States
Florida Hospital Medical Group, Orlando, Florida, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Levine Cancer Institute - Southpark, Charlotte, North Carolina, United States
Providence Portland Medical Center, Portland, Oregon, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
USOR - Virginia Cancer Specialists - Fairfax Office, Fairfax, Virginia, United States
Saint Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia
Peninsula & South Eastern Haematology and Oncology Group, Frankston, Victoria, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Klinikum Klagenfurt Am Worthersee, Klagenfurt, Carinthia, Austria
Krankenhaus Elisabethinen Linz, Linz, Upper Austria, Austria
Cross Cancer Institute, Edmonton, Alberta, Canada
Tom Baker Cancer Center, Calgary, British Columbia, Canada
Toronto University Health Network, Toronto, Ontario, Canada
McGill University Health Centre, Montreal, Quebec, Canada
Beijing Cancer Hospital, Beijing, Beijing, China
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
Jilin Provincial Cancer Hospital (Changchun Cancer Hospital), Changchun, Jilin, China
Shanghai Pulmonary Hospital, Shanghai, Shanghai, China
The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Hopital Haut-Leveque, Pessac, Aquitaine, France
Centre Hospitalier Intercommunal de Creteil, Creteil, Ile-de-france, France
Hopital Larrey, CHU de Toulouse, Service de Pneumologie, Toulouse Cedex 9, Midi-pyrenees, France
Assistance Publique-Hopitaux de Marseille Hopital Nord, Marseille, Provence Alpes COTE D'azur, France
Centre de Lutte Contre le Cancer Centre Leon Berard, Lyon, Rhone-alpes, France
Thoraxklinik Heidelberg gGmbH, Heidelberg, Baden-wuerttemberg, Germany
Universitatsklinikum Ulm, Ulm, Baden-wuerttemberg, Germany
Klinikum Kempten-Oberallgau, Kempten, Bavaria, Germany
Ludwig-Maximilians-Universitat Munchen, Munchen, Bayern, Germany
Pius Hospital Oldenburg, Oldenburg, Niedersachsen, Germany
Evangelisches Krankenhaus Hamm, Hamm, Nordrhein-westfalen, Germany
HELIOS Klinikum Emil von Behring, Berlin, , Germany
Prince of Wales Hospital, Shatin, New Territories, Hong Kong
Queen Mary Hospital, Hong Kong, , Hong Kong
Queen Mary Hospital, Hong Kong, , Hong Kong
Queen Elizabeth Hospital, Kowloon, , Hong Kong
Princess Margaret Hospital - Hong Kong, Kowloon, , Hong Kong
Azienda Ospedaliera San Camillo Forlanini, Roma, Lazio, Italy
Centro di Riferimento Oncologico di Aviano, Aviano, Pordenone, Italy
Azienda Ospedaliero - Universitaria San Luigi Gonzaga, Orbassano, Torino, Italy
Istituto Europeo di Oncologia, Milano, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, , Italy
Azienda Ospedaliero Universitaria di Parma, Parma, , Italy
Azienda USL della Romagna, Ravenna, , Italy
Fujita Health University Hospital, Toyoake, Aichi, Japan
Kanagawa Cancer Center, Yokohama, Kanagawa, Japan
Sendai Kousei Hospital, Sendai, Miyagi, Japan
Okayama University Hospital, Okayama-city, Okayama, Japan
Kansai Medical University Hirakata Hospital, Hirakata-shi, Osaka, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Koto-ku, Tokyo, Japan
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
Gachon University Gil Medical Center, Incheon, Gyeonggi-do, Korea, Republic of
Korea University Anam Hospital, Seoul, Gyeonggi-do, Korea, Republic of
Chungbuk National University Hospital, Cheongju-si, Gyeongsangbuk-do, Korea, Republic of
Keimyung University Dongsan Medical Center, Daegu, , Korea, Republic of
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
Maastricht University Medical Centre, Maastricht, Limburg, Netherlands
Vrije Universiteit Medisch Centrum, Amsterdam, Noord-holland, Netherlands
Erasmus University Medical Center, Rotterdam, Zuid-holland, Netherlands
Institut Catala d'Oncologia Badalona - Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain
Complejo Hospitalario Universitario A Coruna, A Coruna, LA Coruna, Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Universitario Ramon Y Cajal, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario Puerta de Hierro - Majadahonda, Madrid, , Spain
Skanes Universitetssjukhus i Lund, Lund, Skane, Sweden
Karolinska Universitetssjukhuset, Stockholm, , Sweden
Uppsala Akademiska Sjukhus, Uppsala, , Sweden
Changhua Christian Hospital, Changhua City, Changhwa, Taiwan
National Cheng Kung University, Tainan, Tainan CITY, Taiwan
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
Contact Details
Name: Medical Director
Affiliation: Takeda
Role: STUDY_DIRECTOR
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