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NCT02365597 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer
A Phase 2 study of Urothelial Cancer, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 2
- Development phase
- 239
- Enrollment target
- 20
- Study locations
NCT02365597: Active Phase 2 study of Urothelial Cancer, sponsored by Janssen Research & Development.
NCT02365597 is a Phase 2 study of Urothelial Cancer that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 239 participants, below the 565-participant average among 25 other Urothelial Cancer trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02365597, a Phase 2 study of Urothelial Cancer, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 239 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the objective response rate (complete response \[CR\]+ partial response \[PR\]) of the selected dose regimen in participants with metastatic or surgically unresectable urothelial cancers that harbor specific FGFR genomic alterations.
Primary Outcome
Percentage of participants with best (overall) objective response were reported. Best objective response is defined as the best (overall) objective response a participants achieved during the study in the order of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), where CR and PR were confirmed as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. As per RECIST version 1.1, CR was defined as the disappearance of all target lesions. A
Conditions Studied
Interventions
- DRUG Midazolam
- DRUG Metformin
- DRUG Erdafitinib
Study Locations (20)
California
- - Los Angeles
- - Orange
- - Sacramento
- - Stanford
Oregon
- - Medford
- - Tualatin
Pennsylvania
- - Hershey
- - Pittsburgh
Arizona
- - Sedona
Colorado
- - Aurora
District of Columbia
- - Washington D.C.
Illinois
- - Chicago
Iowa
- - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 239 participants |
| Start Date | 2015-04-22 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 2 |
What the registry record for NCT02365597 still lists
NCT02365597 is an interventional study that assigns participants to a tested intervention. The registered 239 participants enrollment target is mid-sized for trials with a published cap, below the 565-participant average among 25 other Urothelial Cancer trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Urothelial Cancer appearing as the primary indexed condition, and to 3 interventions - of which Midazolam is the first listed.
NCT02365597 names 20 study sites across 15 states, led by California, Oregon, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02365597 about?
NCT02365597 is a clinical study titled "An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer". The purpose of this study is to evaluate the objective response rate (complete response \[CR\]+ partial response \[PR\]) of the selected dose regimen in participants with metastatic or surgically unresectable urothelial cancers that harbor specific FGFR genomic alterations.
What is the current status of trial NCT02365597?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 239 participants. The study started on 2015-04-22. Estimated completion is 2027-03-31.
What conditions does trial NCT02365597 study?
This clinical trial studies the following conditions: Urothelial Cancer.
What interventions are being tested in trial NCT02365597?
The interventions under investigation include: Midazolam (DRUG), Metformin (DRUG), Erdafitinib (DRUG).
Who is sponsoring clinical trial NCT02365597?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02365597 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02365597's enrollment target sits among peer trials
239 16th of 25 higher than 10 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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