Last updated on July 2019

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


Brief description of study

The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed 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).

Detailed Study Description

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 followup (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.

Clinical Study Identifier: NCT03390504

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Piedmont Cancer Institute

Atlanta, GA United States
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Rush University

Chicago, IL United States
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Norton Cancer Institute

Louisville, KY United States
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Duke University

Durham, NC United States
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University of Missouri

Columbia, SC United States
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MD Anderson Cancer Center

Houston, TX United States
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Frankston Hospital

Melbourne, Australia
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ZNA Middelheim

Antwerpen, Belgium
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Upco - Hcpa

Porto Alegre, Brazil
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Hopital Jean MINJOZ

Besancon Cedex, France
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Centre Jean Perrin

Clermont Ferrand, France
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Hospital Saint-Louis

Paris Cedex 10, France
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CHU De Poitiers

Poitiers Cedex, France
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I.C.O. Ren Gauducheau

Saint Herblain Cedex, France
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Institut de Canc rologie de Loire

Saint-Priest-en-Jarez, France
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National Cancer Center

Goyangsi, Korea, Republic of
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Samsung Medical Center

Seoul, Korea, Republic of
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Radboud Umcn

Nijmegen, Netherlands
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City Polyprofiled Hospital #2

Saint Petersburg, Russian Federation
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LLC 'Strategic Medical Systems'

Saint-Petersburg, Russian Federation
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Clinical hopital n/a Petra velikogo

Saint-Petersburg, Russian Federation
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Zaokod

Zaporizhzhia, Ukraine
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Charing Cross Hospital

London, United Kingdom
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Southampton General Hospital

Southampton, United Kingdom
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Royal Marsden Hospital

Sutton, United Kingdom
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New Cross Hospital

Wolverhampton, United Kingdom
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UZ Gent

Gent, Belgium
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Institut de Canc rologie de Loire

Saint-Priest-En-Jarez, France
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Recruitment Status: Open


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