Last updated 16 days ago

A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations

629 patients around the world
Available in Argentina, Brazil, Mexico
A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment follow-up (from end-of-treatment to participants death, withdraws consent, lost to follow-up study completion for the respective cohort, whichever comes first). The study will have long term extension (LTE) period after clinical cutoff date is achieved for final analysis of each cohort and participants eligible in the opinion of the investigator, will continue to benefit from the study intervention. Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.
Janssen Research & Development, LLC
14Research sites
629Patients around the world
This study is for people with
Urothelial cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
Sites
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Recruiting
Av. Galvan 4102, CABA, Buenos Aires
Centro Médico Privado CEMAIC - Córdoba
Centro Médico Privado CEMAIC - Córdoba
Recruiting
Monseñor Pablo Cabrera 2941, Córdoba
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Recruiting
25 de mayo 174, Viedma, Río Negro
Hospital Asociación de Beneficencia Hospital Sirio Libanes - CABA, Buenos Aires
Hospital Asociación de Beneficencia Hospital Sirio Libanes - CABA, Buenos Aires
Recruiting
Campana 4658, CABA, Buenos Aires
Centro Urológico Profesor Bengió - Córdoba
Centro Urológico Profesor Bengió - Córdoba
Recruiting
Urquiza 358, 1er Piso.
Hospital Privado de la Comunidad
Recruiting
Córdoba 4545, Mar del Plata, Buenos Aires
Fundación CENIT para la Investigación en Neurociencias
Recruiting
Juncal 2222, C1125 CABA, Argentina
Centro Oncológico Korben
Recruiting
Cdad. de La Paz 353, C1426 CABA, Argentina
Centro de Investigación Pergamino SA
Recruiting
Av. de Mayo 1115, Pergamino, Buenos Aires
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Bloco A1 - Av. Albert Einstein, 627 - Jardim Leonor, São Paulo - SP, 05652-900, Brazil
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