Last updated on September 2018

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 one prior treatment.

Detailed Study Description

A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or PD1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after one prior line of systemic therapy. 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, 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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Study Contact

Centro Oncologico Md Anderson
Madrid, Spain
1.01miles
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Study Contact

Hosp. Gral. Univ. Gregorio Maranon
Madrid, Spain
5.11miles
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