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NCT03390504 · ClinicalTrials.gov registry record · Phase 3
A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations
A Phase 3 study of Urothelial Cancer, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 3
- Development phase
- 629
- Enrollment target
- 20
- Study locations
NCT03390504: Active Phase 3 study of Urothelial Cancer, sponsored by Janssen Research & Development.
NCT03390504 is a Phase 3 study of Urothelial Cancer that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 629 participants, above the 549-participant average among 25 other Urothelial Cancer trials with a reported enrollment target (15% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03390504, a Phase 3 study of Urothelial Cancer, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 629 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-programmed death ligand 1(PD-\[L\]1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).
Primary Outcome
Overall survival was measured from the date of randomization to the date of the participant's death.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Docetaxel
- DRUG Erdafitinib
- DRUG Vinflunine
- DEVICE Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)
Study Locations (20)
California
- University of Calif Davis Medical Center - Sacramento
- St. Helena Hospital - Martin-O'Neil Cancer Center - St. Helena
Florida
- University of Miami Sylvester Cancer Center - Miami
- Mid Florida Hematology Oncology - Orange
Illinois
- Rush University - Chicago
- Edward Hines Jr V A Hospital - Hines
New York
- Weill Cornell Medical College - New York
- Montefiore Medical Center - The Bronx
North Carolina
- Levine Cancer Institute, Carolinas HealthCare System - Charlotte
- W G Bill Hefner VA Medical Center - Salisbury
Alaska
- Alaska Urological Institute dba Alaska Clinical Research Center - Anchorage
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Georgia
- Piedmont Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 629 participants |
| Start Date | 2018-03-23 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 3 |
What the registry record for NCT03390504 still lists
NCT03390504 is an interventional study that assigns participants to a tested intervention. The registered 629 participants enrollment target is mid-sized for trials with a published cap, above the 549-participant average among 25 other Urothelial Cancer trials with a reported enrollment target (15% higher).
The record links to 1 condition, with Urothelial Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03390504 names 20 study sites across 15 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT03390504 about?
NCT03390504 is a clinical study titled "A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations". The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which include...
What is the current status of trial NCT03390504?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 629 participants. The study started on 2018-03-23. Estimated completion is 2026-12-31.
What conditions does trial NCT03390504 study?
This clinical trial studies the following conditions: Urothelial Cancer.
What interventions are being tested in trial NCT03390504?
The interventions under investigation include: Pembrolizumab (DRUG), Docetaxel (DRUG), Erdafitinib (DRUG), Vinflunine (DRUG), Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) (DEVICE).
Who is sponsoring clinical trial NCT03390504?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03390504 being conducted?
This trial has 20 study locations across Alaska, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03390504's enrollment target sits among peer trials
629 8th of 25 higher than 18 of 25 other Urothelial Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urothelial Cancer 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.
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