JNJ-42756493
Sponsors
Janssen Cilag International, Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting, Grupo Espanol De Oncologia Genitourinaria-Socug, Janssen Research & Development, LLC, University Health Network, Toronto
Conditions
Advanced Urothelial CancerAdvanced solid tumorAdvanced solid tumors (other than Urothelial tumors)Cohort 1 and 2: High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
with FGFR Mutations or Fusions
Cohort 3 Intermediate Risk Non-Muscle-Invasive Bladder Cancer
(NMIBC) with FGFR Mutations or FusionsFGFR+ Intermediate-risk Non-muscle Invasive Bladder CancerHealthyHigh-risk Non-muscle-invasive Bladder
Cancer with Susceptible FGFR AlterationsMetastatic or Locally Advanced Urothelial Cancer
Phase 1
A Study to Assess the Absorption, Metabolism, and Routes of Excretion Following Oral Administration of (14C) Radiolabeled JNJ--42756493 to Healthy Male Participants
CompletedNCT02692677
Start: 2016-03-31End: 2016-08-31Updated: 2017-10-23
A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and
Pharmacodynamics of Various Regimens of Erdafitinib in Subjects with Metastatic or
Locally Advanced Urothelial Cancer
Active, not recruitingCTIS2023-510295-31-00
Start: 2018-09-24Target: 7Updated: 2025-08-20
Phase 2
Testing JNJ-42756493 In Combination With Dexamethasone in Multiple Myeloma That Came Back After a Period of Improvement
TerminatedNCT02952573
Start: 2017-06-13End: 2018-11-13Updated: 2020-09-17
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
Active, not recruitingCTIS2023-510273-34-00
Start: 2015-04-24Target: 5Updated: 2025-08-22
A Phase 2 Study of Erdafitinib in Subjects with Advanced Solid Tumors and FGFR Gene Alterations
Active, not recruitingCTIS2023-510301-18-00
Start: 2019-12-05Target: 2Updated: 2025-08-06
A Dutch National Study on behalf of the Center for Personalized Cancer Treatment (CPCT) to Facilitate Patient Access to Commercially Available, Targeted Anti-cancer Drugs to determine the Potential Efficacy in Treatment of Advanced Cancers with a Known Molecular Profile: The Drug Rediscovery Protocol (DRUP trial)
RecruitingCTIS2023-509152-33-00
Start: 2016-07-25Target: 3000Updated: 2025-12-19
A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical
Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred
With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or
Fusions
CompletedCTIS2023-510306-40-00
Start: 2020-08-11End: 2025-02-27Target: 6Updated: 2025-01-22
A Phase 2, open-label, multi-centre, multi-national interventional trial to evaluate the efficacy and safety of erdafitinib (ERDA) monotherapy and erdafitinib (ERDA) and cetrelimab (CET) combination as neoadjuvant treatment in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC) whose tumours express FGFR gene alterations (SOGUG-NEOWIN)
RecruitingCTIS2024-512573-27-01
Start: 2023-12-11Target: 62Updated: 2025-09-02
Phase 3
A Phase 3 Study of Erdafitinib Compared with Vinflunine or Docetaxel or Pembrolizumab
in Subjects with Advanced Urothelial Cancer and Selected FGFR Gene Aberrations
Active, not recruitingCTIS2023-510296-56-00
Start: 2018-03-26Target: 179Updated: 2025-08-26
Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations
Active, not recruitingCTIS2023-507684-19-00
Start: 2024-07-24Target: 201Updated: 2025-10-27
A Phase 3, Randomized, Open-label, Multicenter Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Investigator’s Choice of Intravesical Chemotherapy in Participants with High-risk Non-muscle-invasive Bladder Cancer with Susceptible FGFR Alterations Who Had Received Intravesical Bacillus Calmette-Guérin (BCG)
RecruitingCTIS2024-519493-39-00
Start: 2025-12-09Target: 90Updated: 2025-11-10