Study Summary
This trial is testing a new way to give a drug to people with bladder cancer. They will find out how much of the drug is safe, and then study how well it works.
- Bladder Cancer
- Fibroblast Growth Factor Receptors
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 8 Secondary · Reporting Duration: Cohorts 1 and 3: up to 6 months; Cohort 2 and 4: up to 8 weeks
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Part 1: Dose Escalation
1 of 2
Part 2: Dose Expansion
1 of 2
Experimental Treatment
92 Total Participants · 2 Treatment Groups
Primary Treatment: Erdafitinib Intravesical Delivery System · No Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| California | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| University of Southern California | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
Frequently Asked Questions
Are there still openings available to participate in this experiment?
"Yes, based on the clinicaltrials.gov website this experiment is still recruiting patients; it was originally posted April 11th 2022 and has been recently amended November 3rd 2022." - Anonymous Online Contributor
What is the geographical extent of this clinical examination?
"This clinical trial can be accessed at a number of different locations, such as Northwestern University in Chicago, Carolina Urologic Research Center in Myrtle Beach, and Urology Associates in Nashville. Additionally there are 3 other available sites." - Anonymous Online Contributor
What are the desired outcomes of this medical experiment?
"This clinical trial, which will last up to 5 years and 3 months, seeks to evaluate the number of participants affected by adverse events. It also measures the urine concentration of erdafitinib in patients, their duration of complete response (CR), as well as plasma concentrations of erdafitinib." - Anonymous Online Contributor
Has the Erdafitinib Intravesical Delivery System been sanctioned by the FDA?
"There is only a small amount of research exploring the safety and effectiveness of Erdafitinib Intravesical Delivery System, prompting us to rate its risk level at 1." - Anonymous Online Contributor
What is the upper limit of individuals involved in this scientific investigation?
"In order to pursue the research, Janssen Research & Development, LLC is in need of 92 patients that fulfill all prerequisites. The trial will be conducted from two sites: Northwestern University located in Chicago and Carolina Urologic Research Center situated at Myrtle Beach." - Anonymous Online Contributor