Spots Global Cancer Trial Database for A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations
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Trial Identification
Brief Title: A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations
Official Title: A Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and FGFR Gene Alterations
Study ID: NCT04083976
Conditions
Interventions
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy of erdafitinib in terms of overall response rate (ORR) in adult and pediatric participants with advanced solid tumors with fibroblast growth factor receptor (FGFR) alterations (mutations or gene fusions). It will also evaluate ORR in pediatric participants with advanced solid tumors and FGFR alterations.
Detailed Description: Erdafitinib is a selective and potent pan FGFR 1-4 inhibitor with demonstrated clinical activity in participants with metastatic urothelial cancer and cholangiocarcinoma identified to have alterations in the FGFR pathway. This study targets the underlying altered biology of FGFR-driven tumors irrespective of solid tumor histology subtype. The study consists of screening phase, treatment phase and the post treatment follow-up phase (from the end of treatment visit until the participant has died, withdraws consent, is lost to follow-up, or the end of study, whichever comes first). End of study is considered as the time when the last participant receives the last dose of study drug on the study and either all pediatric participants are off study or until the most recently enrolled pediatric participant still participating in the study has 6 months of follow-up, whichever occurs first. Currently this study is recruiting pediatric participants only.
Keywords
Eligibility
Minimum Age: 6 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Oncology Associates, PC - HOPE, Tucson, Arizona, United States
Rocky Mountain Cancer Centers, Colorado Springs, Colorado, United States
Memorial Cancer Institute, Hollywood, Florida, United States
Cancer Specialists of North Florida, Jacksonville, Florida, United States
Emory University, Atlanta, Georgia, United States
Hawaii Cancer Care, 'Aiea, Hawaii, United States
Maine Medical Center, Scarborough, Maine, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Henry Ford Hospital, Detroit, Michigan, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Mount Sinai, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Levine Cancer Institute, Carolinas HealthCare System, Charlotte, North Carolina, United States
Oncology Hematology Care, Cincinnati, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Tennessee Oncology, PLLC, Chattanooga, Tennessee, United States
Tennessee Oncology, Nashville, Tennessee, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Texas Oncology-Fort Worth Cancer Center, Fort Worth, Texas, United States
MD Anderson, Houston, Texas, United States
Oncology Consultants - Texas, Houston, Texas, United States
Texas Oncology Odessa-West Texas Cancer Center, Odessa, Texas, United States
Texas Oncology San Antonio Northeast, San Antonio, Texas, United States
NorthWest Medical Specialties, PLLC, Tacoma, Washington, United States
Aurora Research Institute, Wauwatosa, Wisconsin, United States
Hospital Aleman, Buenos Aires, , Argentina
Centro Oncológico Korben, Ciudad Autonoma de Buenos Aires, , Argentina
Instituto Fleni, Ciudad Autonoma de Buenos Aires, , Argentina
CEMIC Saavedra, Ciudad Autonoma de Buenos Aires, , Argentina
Instituto de Investigaciones Metabólicas, Ciudad Autónoma de Buenos Aires, , Argentina
Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica, Cordoba, , Argentina
Hospital Italiano de La Plata, La Plata Lpl Lpl, , Argentina
Instituto de Investigaciones Clinicas Mar del Plata, Mar Del Plata, Buenos Aires, , Argentina
Hospital Privado de Comunidad, Mar Del Plata, , Argentina
Hospital Universitario Austral, Pilar, , Argentina
Sanatorio Britanico de Rosario, Rosario, , Argentina
ARS Médica, San Salvador De Jujuy, , Argentina
Flinders Centre for Innovation in Cancer, Adelaide, , Australia
Chris O'Brien Lifehouse, Camperdown, , Australia
St. Vincent's Hospital Sydney, Darlinghurst, , Australia
St Vincents Hospital Melbourne, Fitzroy, , Australia
Fiona Stanley Hospital, Murdoch, , Australia
Intergrated Clinical Oncology Network Pty Ltd (ICON), South Brisbane, , Australia
AZ Klina, Brasschaat, , Belgium
UCL Hopital Saint-Luc, Bruxelles, , Belgium
Grand Hopital de Charleroi, site Notre Dame, Charleroi, , Belgium
CHU UCL Namur - Site Dinant, Dinant, , Belgium
UZA, Edegem, , Belgium
AZ Maria Middelares, Gent, , Belgium
UZ Gent, Gent, , Belgium
Jolimont, Haine-Saint-Paul, La Louviere, , Belgium
CHU UCL Namur - Site Sainte Elisabeth, Namur, , Belgium
Cliniques St Pierre, Ottignies, , Belgium
CHU UCL Namur - Site Godinne, Yvoir, , Belgium
Fundacao Pio XII, Barretos, , Brazil
Liga Paranaense de Combate ao Cancer, Curitiba, , Brazil
Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge, Goiania, , Brazil
Associacao Hospital de Caridade Ijui, Ijui, , Brazil
Liga Norte Riograndense Contra O Cancer, Natal, , Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre, Porto Alegre, , Brazil
Instituto de Medicina Integral Professor Fernando Figueira, Recife, , Brazil
Oncoclinicas Rio de Janeiro S A, Rio de Janeiro, , Brazil
Instituto D Or de Pesquisa e Ensino (IDOR), Rio de Janeiro, , Brazil
Hospital Sao Rafael, Salvador, , Brazil
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, , Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center, Sao Paulo, , Brazil
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês, São Paulo, , Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia, São Paulo, , Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP, São Paulo, , Brazil
GRAACC, São Paulo, , Brazil
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, , China
Beijing Tiantan Hospital, Capital Medical University, Beijing, , China
Peking University Third Hospital, Beijing, , China
Chinese PLA General Hospital, Beijing, , China
Beijing Luhe Hospital, Capital Medical University, Beijing, , China
Jilin cancer hospital, Changchun, , China
The First Hospital of Jilin University, Changchun, , China
West China Hospital,Sichuan University, Chengdu, , China
Chongqing Southwest Hospital, Chongqing, , China
Third Military Medical University Daping Hospital Cancer Center, Chongqing, , China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, , China
First affiliated Hospital of Zhejiang University, Hangzhou, , China
Zhejiang Cancer Hospital, Hangzhou, , China
Eastern Theater General Hospital, Qinhuai District Medical Area, Nanjing, , China
Ruijin Hospital Shanghai Jiao Tong University, Shanghai, , China
Cancer Hospital, FuDan University, Shanghai, , China
Shanghai Zhongshan Hospital, Shanghai, , China
Huashan Hospital Fudan University, Shanghai, , China
Hopital Saint André, Bordeaux, , France
Centre Francois Baclesse, Caen, , France
Centre Jean Perrin, Clermont Ferrand, , France
Centre Georges François Leclerc, Dijon, , France
Centre Oscar Lambret, Lille, , France
Centre Leon Berard, Lyon, , France
Hopital de la Timone, Marseille, , France
Institut Curie, Paris, , France
CHU De Poitiers, Poitiers, , France
Institut de Cancérologie de Lorraine, Vandoeuvre lès Nancy, , France
Institut Gustave Roussy, Villejuif, , France
Charité, Berlin, , Germany
Medizinische Fakultat Carl Gustav Carus Technische Universitat Dresden, Dresden, , Germany
Universitaetsklinikum Essen, Essen, , Germany
Universitaetsklinikum Frankfurt, Frankfurt, , Germany
Asklepios Klinik Altona, Hamburg, , Germany
Universitaetsklinikum Heidelberg, Heidelberg, , Germany
Universitaetsklinikum Koeln, Köln, , Germany
Universitaetsklinikum Leipzig, Leipzig, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, , Germany
Klinikum rechts der Isar der TU Munchen, München, , Germany
Universitatsklinikum Tubingen, Tübingen, , Germany
Istituto Ortopedico Rizzoli, Bologna, , Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano, , Italy
ASST di Monza, Monza, , Italy
Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli, Napoli, , Italy
Fondazione G Pascale Istituto Nazionale Tumori IRCCS, Napoli, , Italy
Ospedale S. Maria Della Misericordia, Perugia, , Italy
Ospedale Santa Chiara AO Universitaria Pisana, Pisa, , Italy
Azienda Ospedaliera S. Maria Terni, Terni, , Italy
Ospedale Borgo Roma, Verona, , Italy
National Cancer Center Hospital, Chuo Ku, , Japan
Hiroshima University Hospital, Hiroshima shi, , Japan
National Cancer Center Hospital East, Kashiwa, , Japan
National Hospital Organizaiton Shikoku Cancer Center, Matsuyama, , Japan
Fujita Health University Hospital, Toyoake, , Japan
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy, Bydgoszcz, , Poland
Przychodnia Lekarska KOMED Roman Karaszewski, Konin, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie, Krakow, , Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi, Lodz, , Poland
Centrum Medyczne Pratia Poznan, Skorzewo, , Poland
Instytut Matki i Dziecka, Warszawa, , Poland
Centralny Szpital Kliniczny MSWiA w Warszawie, Warszawa, , Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy, Warszawa, , Poland
Hosp. Univ. Quiron Dexeus, Barcelona, , Spain
Hosp. Univ. Vall D Hebron, Barcelona, , Spain
Hosp. Clinic de Barcelona, Barcelona, , Spain
Hosp. Sant Joan de Deu, Barcelona, , Spain
Inst. Cat. Doncologia-H Duran I Reynals, Hospitalet de Llobregat, Barcelona, , Spain
Hosp. Infantil Univ. Nino Jesus, Madrid, , Spain
Clinica Univ. de Navarra, Madrid, , Spain
Hosp. Univ. Ramon Y Cajal, Madrid, , Spain
Hosp. Univ. Fund. Jimenez Diaz, Madrid, , Spain
Hosp. Univ. 12 de Octubre, Madrid, , Spain
Hosp. Univ. La Paz, Madrid, , Spain
Hosp. Virgen Del Rocio, Sevilla, , Spain
Hosp. Clinico Univ. de Valencia, Valencia, , Spain
Changhua Christian Hospital, Changhua, , Taiwan
E-Da Cancer Hospital, Kaohsiung City, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
Chang Gung Medical Foundation, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
Chi Mei Medical Center Yong Kang, Tainan, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Chi Mei Medical Center Liu Ying, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital Linkou Branch, Taoyuan City, , Taiwan
Bristol Royal Hospital for Children, Bristol, , United Kingdom
Bristol Haematology and Oncology Centre, Bristol, , United Kingdom
The Christie Nhs Foundation Trust, Manchester, , United Kingdom
Freeman Hospital, Newcastle upon Tyne, , United Kingdom
Derriford Hospital, Plymouth, , United Kingdom
The Royal Marsden NHS Trust, Sutton, , United Kingdom
The Clatterbridge Cancer Centre, Wirral, , United Kingdom
Contact Details
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
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