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NCT05316155 · ClinicalTrials.gov registry record · Phase 1
Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
A Phase 1 study of Non-Muscle Invasive Bladder Neoplasms, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 235
- Enrollment target
- 20
- Study locations
NCT05316155: Recruiting Phase 1 study of Non-Muscle Invasive Bladder Neoplasms, sponsored by Janssen Research & Development.
NCT05316155 is a Phase 1 study of Non-Muscle Invasive Bladder Neoplasms that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 235 participants, below the 274-participant average among 6 other Non-Muscle Invasive Bladder Neoplasms trials with a reported enrollment target (14% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05316155, a Phase 1 study of Non-Muscle Invasive Bladder Neoplasms, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 235 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study in Part 1 (dose escalation) and in Part 2 (dose expansion) is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) and evaluate preliminary clinical efficacy. Part 3 (dose expansion) will confirm safety and preliminary clinical activity at the RP2D. Part 4 (RP2D expansion; MoonRISe-2) will assess the overall complete response (CR) in participants with intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC; means the cancer cells are only in the bladder's inner lining).
Primary Outcome
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Conditions Studied
Interventions
- DRUG Erdafitinib Intravesical Delivery System
Study Locations (20)
Florida
- Urological Research Network - Hialeah
- Advanced Urology Institute - Largo
- Advent Health Orlando - Orlando
- Advanced Urology Institute - Oxford
- H Lee Moffitt Cancer Center - Tampa
Illinois
- Northwestern University - Chicago
- Associated Urological Specialists - Chicago Ridge
Indiana
- Urology of Indiana - Greenwood
- Urologic Specialists of Northwest Indiana - Merrillville
Alabama
- University of Alabama at Birmingham - The Kirklin Clinic - Birmingham
California
- University of Southern California - Los Angeles
Colorado
- Urology Associates of Denver - Lone Tree
Kentucky
- University of Kentucky - Lexington
Louisiana
- Southern Urology LLC - Lafayette
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 235 participants |
| Start Date | 2022-04-11 |
| Est. Completion | 2029-07-24 |
| Phase | Phase 1 |
What NCT05316155 shows while recruiting
NCT05316155 is an interventional study that assigns participants to a tested intervention. The registered 235 participants enrollment target is mid-sized for trials with a published cap, below the 274-participant average among 6 other Non-Muscle Invasive Bladder Neoplasms trials with a reported enrollment target (14% lower).
The record links to 1 condition, with Non-Muscle Invasive Bladder Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which Erdafitinib Intravesical Delivery System is the first listed.
NCT05316155 names 20 study sites across 14 states, led by Florida, Illinois, Indiana.
Frequently Asked Questions
What is clinical trial NCT05316155 about?
NCT05316155 is a clinical study titled "Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer". The purpose of the study in Part 1 (dose escalation) and in Part 2 (dose expansion) is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) and evaluate preliminary clinical efficacy. Part 3 (dose expansion) will confirm safety and preliminary clinical activity at the RP2D. Part 4 (RP2D expansio...
What is the current status of trial NCT05316155?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 235 participants. The study started on 2022-04-11. Estimated completion is 2029-07-24.
What conditions does trial NCT05316155 study?
This clinical trial studies the following conditions: Non-Muscle Invasive Bladder Neoplasms.
What interventions are being tested in trial NCT05316155?
The interventions under investigation include: Erdafitinib Intravesical Delivery System (DRUG).
Who is sponsoring clinical trial NCT05316155?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05316155 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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