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A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
NCT04172675 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator's Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor fibroblast growth factor receptor (FGFR) mutations or fusions, and who recurred after bacillus calmette-guerin (BCG) therapy.
Conditions Studied
Interventions
- DRUG Erdafitinib
- DRUG Investigator Choice (Gemcitabine)
- DRUG Investigator Choice (Mitomycin C)
Study Locations (20)
New York
- Albany Medical College — Albany
- NYU Langone Health — New York
- Great Lakes Physician PC d/b/a Western New York Urology Associates — Sanborn
- Montefiore Medical Center — The Bronx
Illinois
- Northwestern University — Chicago
- Simmons Cancer Institute — Springfield
Ohio
- The Urology Group — Cincinnati
- The Ohio State University- James Cancer Hospital — Columbus
Pennsylvania
- MidLantic Urology — Bala-Cynwyd
- University of Pittsburgh Medical Center - Cancer Centers — Pittsburgh
Arizona
- Urological Associates of Southern Arizona, P.C. — Tucson
California
- USC Institute of Urology — Los Angeles
Colorado
- The Urology Center of Colorado — Denver
Florida
- Urological Research Network — Hialeah
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2020-02-28 |
| Est. Completion | 2025-02-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04172675
The ClinicalTrials.gov registry entry for NCT04172675 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Urinary Bladder Neoplasms appearing as the primary indexed condition, and to 3 interventions — of which Erdafitinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04172675 reports 20 study locations spanning 14 distinct geographic areas — top geographies include New York, Illinois, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04172675 about?
NCT04172675 is a clinical study titled "A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)". The purpose of this study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator's Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor fibroblast growth factor receptor (FGFR) mutations or fusions, and who recu...
What is the current status of trial NCT04172675?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 107 participants. The study started on 2020-02-28. Estimated completion is 2025-02-27.
What conditions does trial NCT04172675 study?
This clinical trial studies the following conditions: Urinary Bladder Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04172675?
The interventions under investigation include: Erdafitinib (DRUG), Investigator Choice (Gemcitabine) (DRUG), Investigator Choice (Mitomycin C) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04172675?
This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04172675 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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