Spots Global Cancer Trial Database for A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer
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Trial Identification
Brief Title: A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer
Official Title: A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Various Regimens of Erdafitinib in Subjects With Metastatic or Locally Advanced Urothelial Cancer
Study ID: NCT03473743
Conditions
Study Description
Brief Summary: The purpose of this study is to: (a) characterize the safety and tolerability of and to identify the recommended Phase 2 dose (RP2D) and schedule for erdafitinib in combination with cetrelimab, and for erdafitinib in combination with cetrelimab and platinum (cisplatin and carboplatin) chemotherapy and; (b) to evaluate the safety and clinical activity of erdafitinib alone and in combination with cetrelimab in cisplatin-ineligible participants with metastatic or locally advanced urothelial cancer (UC) with select fibroblast growth factor receptor (FGFR) gene alterations and no prior systemic therapy for metastatic disease.
Detailed Description: This open-label (all people know identity of intervention) and multicenter (when more than one hospital or medical school team work on a medical research study) study to establish the recommended phase 2 dose (RP2D) for erdafitinib and cetrelimab and/or platinum (cisplatin or carboplatin) chemotherapy, and to evaluate the safety of erdafitinib in combination with cetrelimab and platinum chemotherapy in Phase 1b and to evaluate the safety and efficacy of the RP2D of erdafitinib plus cetrelimab versus erdafitinib in Phase 2 in participants with advanced urothelial cancer with select fibroblast growth factor receptor (FGFR) gene alterations. Participants enrolled in Phase 1b erdafitinib + cetrelimab cohort may have received any number of lines of prior therapy, and participants enrolled in Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort will have had no prior systemic therapy for metastatic disease and participants enrolled in Phase 2 will have had no prior systemic therapy for metastatic disease and will be cis-ineligible. Part 1 (Phase 1b: Dose Escalation) will identify safety and RP2Ds of erdafitinib + cetrelimab and erdafitinib + cetrelimab + platinum (cisplatin or carboplatin) chemotherapy, and Part 2 (Phase 2: Dose Expansion) will evaluate erdafitinib monotherapy and the RP2D regimen of the erdafitinib + cetrelimab combination to further characterize safety and clinical activity. The study will be conducted in 3 phases: screening phase, treatment phase, and follow-up phase. Study evaluations include efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, biomarkers, and safety.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Rocky Mountain Cancer Centers, Aurora, Colorado, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Maryland Oncology Hematology, PA, Rockville, Maryland, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Weill Cornell Medical College - NY Presbyterian Hospital, New York, New York, United States
White Plains Hospital Center for Cancer Care, White Plains, New York, United States
Levine Cancer Institute, Carolinas HealthCare System, Charlotte, North Carolina, United States
Toledo Clinic Cancer Centers, Toledo, Ohio, United States
Penn State Hershey Cancer Institute, Hershey, Pennsylvania, United States
Texas Oncology, P.A., Fort Worth, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Brest Regional Oncology Dispensary, Brest, , Belarus
Gomel Regional Clinical Oncology Dispensary, Gomel, , Belarus
Grodno University Hospital, Grodno, , Belarus
State Institution N.N. Alexandrov Republican Scientific and, Lesnoy, , Belarus
Minsk city Clinical Oncological Dispensary, Minsk, , Belarus
Mogilev Regional Hospital, Mogilev, , Belarus
Vitebsk Regional Clinical Hospital, Vitebsk, , Belarus
ULB Hôpital Erasme, Bruxelles, , Belgium
Cliniques Universitaires Saint Luc, Bruxelles, , Belgium
Jolimont, Haine-Saint-Paul, La Louviere, , Belgium
Az Groeninge, Kortrijk, , Belgium
CHU de Liège - Domaine Universitaire du Sart Tilman, Liege, , Belgium
AZ Nikolaas - Campus Sint-Niklaas Moerland, Sint-Niklaas, , Belgium
GZA Ziekenhuizen- Campus St Augustinus, Wilrijk, , Belgium
Fundacao Pio XII, Barretos, , Brazil
Santa Casa de Misericordia de Belo Horizonte, Belo Horizonte, , Brazil
Liga Paranaense de Combate ao Cancer, Curitiba, , Brazil
Oncocentro Servicos Medicos e Hospitalares Ltda - Oncocentro, Fortaleza, , Brazil
Oncoclinicas Rio de Janeiro S A, Rio de Janeiro, , Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI), Rio de Janeiro, , Brazil
CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia, Santo Andre, , Brazil
Institut de Cancerologie de Ouest (ICO) Site Paul Papin, Angers Cedex 02, , France
Hopital Saint André, Bordeaux, , France
Centre Francois Baclesse, Caen, , France
Centre hospitalier Saint Louis, La Rochelle Cedex 1, , France
Centre Leon Berard, Lyon, , France
APHM Hopital Timone, Marseille, , France
Hôpital Européen Georges Pompidou, Paris, , France
Clinique Sainte Anne, Strasbourg, , France
CHRU de Tours, Tours, , France
Institut de Cancérologie de Lorraine, Vandoeuvre lès Nancy, , France
Institut Gustave Roussy, Villejuif, , France
Cliniche Humanitas Gavazzeni, Bergamo, , Italy
Istituto di Candiolo, IRCCS, Candiolo, , Italy
Ospedale Di Zona B Ramazzini, Carpi, , Italy
UOS Oncologia Medica, A.O. Cannizzaro, Catania, , Italy
Arcispedale S. Anna Ferrara, Ferrara, , Italy
PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco, Lecco, , Italy
Ospedale Civile Di Livorno, Livorno, , Italy
IRCCS Ospedale San Raffaele, Milano, , Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano, , Italy
Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica, Perugia, , Italy
AUSL DI PIACENZA - Ospedale Guglielmo da Saliceto, Piacenza, , Italy
Campus Bio Medico di Roma, Roma, , Italy
Azienda Socio Sanitaria Territoriale (ASST) della Valtellin, Sondrio, , Italy
Azienda Ospedaliera S. Maria Terni, Terni, , Italy
Azienda Ospedaliero Universitaria S.Maria Della Misericordia, Udine, , Italy
Chungnam National University Hospital, Daejeon, , Korea, Republic of
Chonnam National University Hospital, Gwangju, , Korea, Republic of
The Catholic university of Korea, St. Vincent's Hospital, Gyeonggi-do, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Kangbuk Samsung Hospital, Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, , Korea, Republic of
Pusan National University Yangsan Hospital, Yangsan-si, , Korea, Republic of
Przychodnia Lekarska KOMED Roman Karaszewski, Konin, , Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi, Lodz, , Poland
LUX MED Onkologia Sp. z o.o., Warszawa, , Poland
Centralny Szpital Kliniczny MSWiA w Warszawie, Warszawa, , Poland
Altai Regional Oncology Dispensary, Barnaul, , Russian Federation
Ivanovo Regional Oncology Dispensary, Ivanovo, , Russian Federation
GUZ Kursk Regional Oncology Dispensary, Kislino Village, Ryshkovsky Ru, , Russian Federation
Leningrad Regional Oncology Dispensary, Kuzmolovsky, , Russian Federation
City Clinical Hospital n.a. D.D.Pletnev, Moscow, , Russian Federation
Russian Scientific Center of Roentgenoradiology, Moscow, , Russian Federation
Moscow City Clinical Hospital # 62, Moscow, , Russian Federation
Clinical Diagnostic Centre of Nizhny Novgorod Region, Nizhny Novgorod, , Russian Federation
Privolzhsky District Medical Centre, Nizhny Novgorod, , Russian Federation
Clinical Oncology Dispensary, Omsk, , Russian Federation
LLC Novaya Clinica, Pyatigorsk, , Russian Federation
Private Medical Institution Euromedservice, Saint Petersburg, , Russian Federation
Russian Scientific Center of Radiology and Surgical Technologies, Sankt-Peterburg, , Russian Federation
Tambov Regional Oncology Clinical Dispansary, Tambov, , Russian Federation
Multifunctional clinical medical center 'Medical city', Tyumen, , Russian Federation
Hosp. Del Mar, Barcelona, , Spain
Hosp. Clinic de Barcelona, Barcelona, , Spain
Hosp. Univ. Ramon Y Cajal, Madrid, , Spain
Hosp. Clinico San Carlos, Madrid, , Spain
Hosp. Univ. Fund. Jimenez Diaz, Madrid, , Spain
Hosp. Univ. Hm Sanchinarro, Madrid, , Spain
Hosp. Virgen de La Victoria, Málaga, , Spain
Complexo Hosp. Univ. de Ourense, Ourense, , Spain
Complejo Hospitalario de Vigo, Pontevedra, , Spain
Hosp. Quiron Madrid Pozuelo, Pozuelo de Alarcon, , Spain
Corporacio Sanitari Parc Tauli, Sabadell, , Spain
Hosp. Univ. Marques de Valdecilla, Santander, , Spain
H. Clinico Universitario de Santiago de Compostela, Santiago de Compostela, , Spain
Hosp. Virgen Macarena, Sevilla, , Spain
Hosp. Virgen Del Rocio, Sevilla, , Spain
Instituto Valenciano de Oncologia, Valencia, , Spain
Hosp. Clinico Univ. de Valencia, Valencia, , Spain
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung City, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei City, , Taiwan
Chang-Gung Memorial Hospital, LinKou Branch, Taoyuan, , Taiwan
Adana Acibadem Hospital, Adana, , Turkey
Memorial Ankara Hastanesi, Ankara, , Turkey
Hacettepe University Medical Faculty, Ankara, , Turkey
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital, Ankara, , Turkey
Adnan Menderes University Training and Research Hospital, Aydin, , Turkey
Trakya University Medical Faculty, Edirne, , Turkey
Istanbul University Cerrahpasa Medical Faculty, Istanbul, , Turkey
Istanbul Medeniyet University Goztepe Training and Research Hospital, Istanbul, , Turkey
Ege University, Izmir, , Turkey
Kocaeli University Medical Faculty, Kocaeli, , Turkey
Necmettin Erbakan University Meram Medical Faculty, Konya, , Turkey
Karadeniz Teknik University Medical Faculty, Trabzon, , Turkey
Royal Lancaster Infirmary, Lancaster, , United Kingdom
St Bartholomew's Hospital, London, , United Kingdom
University College London Hospitals Nhs Foundation Trust, London, , United Kingdom
Nottingham University Hospitals NHS Trust, Nottingham, , United Kingdom
Contact Details
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
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