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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 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.
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.
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 307-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (65% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.
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