# An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer

Source: https://onco.cc/trials/nct02365597/  
OnCo record `nct02365597` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2 trial of Erdafitinib in bladder & urothelial cancer, run by Janssen Research & Development, LLC, active and no longer recruiting.

## Summary

An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer is a phase 2 interventional study registered as NCT02365597 by Janssen Research & Development, LLC, with 239 participants enrolled, started 2015-04-22 and due to reach its primary completion in 2022-09-15. Interventions recorded: Erdafitinib, Midazolam and Metformin. Results have been posted on the registry.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-22
- Tags: pipeline; ctgov-ingest
- Registry id: NCT02365597
- Phase: 2
- Setting: A Phase 2, Two-arm Multicenter, Open-Label Study to Determine the Efficacy and the Safety of Two Different Dose Regimens of a Pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Subjects With Metastatic or Surgically Unresectable Urothelial Cancer With FGFR Genomic Alterations
- Sponsor: Janssen Research & Development, LLC
- Enrolled: 239
- Outcomes: Main Study: Percentage of Participants With Best (Overall) Objective Response: Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg 21.2% vs Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg 34.6% vs Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg 39.6%; Main Study: Overall Survival: Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg 7.46 months vs Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg 8.64 months vs Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg 11.3 months; Main Study: Progression-free Survival (PFS): Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg 4.8 months vs Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg 5.26 months vs Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg 5.52 months

## Sources

- ClinicalTrials.gov NCT02365597: https://clinicaltrials.gov/study/NCT02365597

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [Muscle-invasive and advanced bladder cancer](https://onco.cc/cancers/muscle-invasive-bladder-cancer/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- drugs: [Erdafitinib](https://onco.cc/drugs/erdafitinib/)
- companies: [Johnson & Johnson](https://onco.cc/companies/johnson-johnson/)

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