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NCT04172675 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study of Urinary Bladder Neoplasms, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 107
- Enrollment target
- 20
- Study locations
NCT04172675: Completed Phase 2 study of Urinary Bladder Neoplasms, sponsored by Janssen Research & Development.
NCT04172675 is a Phase 2 study of Urinary Bladder Neoplasms that has completed, run by Janssen Research & Development. The registered enrollment target is 107 participants, below the 307-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04172675, a Phase 2 study of Urinary Bladder Neoplasms, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 107 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
RFS was defined as the time from the date of randomization until the date of the reappearance of high-risk disease (high-grade Ta, T1 or carcinoma in situ \[CIS\]), or death, whichever was reported first. Recurrence was assessed using cystoscopy, bladder mapping, urine cytology, and computed tomography (CT)/ magnetic resonance imaging (MRI) urogram. Participants who were recurrence-free and alive or had unknown status were censored at the last tumor assessment. The Kaplan-Meier method was used t
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 |
What the finished NCT04172675 record still lists
NCT04172675 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 307-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (65% lower).
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.
NCT04172675 names 20 study sites across 14 states, led by New York, Illinois, Ohio.
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.
What interventions are being tested in trial NCT04172675?
The interventions under investigation include: Erdafitinib (DRUG), Investigator Choice (Gemcitabine) (DRUG), Investigator Choice (Mitomycin C) (DRUG).
Who is sponsoring clinical trial NCT04172675?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04172675's enrollment target sits among peer trials
107 14th of 19 higher than 6 of 19 other Urinary Bladder Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urinary Bladder Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)
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