{"entity":{"id":"nct02365597","kind":"trial","name":"An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer","aka":[],"tldr":"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.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02365597","url":"https://clinicaltrials.gov/study/NCT02365597"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["erdafitinib"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"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","started":"2015-04-22","startedType":"actual","yearReported":2023,"enrolled":239,"enrolledBasis":"registry","outcomes":[{"endpoint":"Main Study: Percentage of Participants With Best (Overall) Objective Response","primary":true,"unit":"%","arms":[{"name":"Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg","n":33,"value":21.2,"note":"Figures from the ClinicalTrials.gov results section (first posted 2023-10-10), not from a publication"},{"name":"Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg","n":78,"value":34.6},{"name":"Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg","n":101,"value":39.6}],"source":"https://clinicaltrials.gov/study/NCT02365597?tab=results"},{"endpoint":"Main Study: Overall Survival","unit":"months","arms":[{"name":"Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg","n":33,"value":7.46,"note":"range 1.7 to 64.0; Figures from the ClinicalTrials.gov results section (first posted 2023-10-10), not from a publication"},{"name":"Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg","n":78,"value":8.64,"note":"range 0.4 to 60.1"},{"name":"Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg","n":101,"value":11.3,"note":"range 0.7 to 56.9"}],"source":"https://clinicaltrials.gov/study/NCT02365597?tab=results"},{"endpoint":"Main Study: Progression-free Survival (PFS)","unit":"months","arms":[{"name":"Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg","n":33,"value":4.8,"note":"range 1.1 to 25.3; Figures from the ClinicalTrials.gov results section (first posted 2023-10-10), not from a publication"},{"name":"Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg","n":78,"value":5.26,"note":"range 0.4 to 57.9"},{"name":"Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg","n":101,"value":5.52,"note":"range 0.0 to 51.5"}],"source":"https://clinicaltrials.gov/study/NCT02365597?tab=results"}]},"route":"/trials/nct02365597/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"muscle-invasive-bladder-cancer","kind":"cancer","name":"Muscle-invasive and advanced bladder cancer","route":"/cancers/muscle-invasive-bladder-cancer/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"erdafitinib","kind":"drug","name":"Erdafitinib","route":"/drugs/erdafitinib/"}],"company":[{"id":"johnson-johnson","kind":"company","name":"Johnson & Johnson","route":"/companies/johnson-johnson/"}]}}