Erdafitinib Intravesical Delivery System for Bladder Cancer

Phase-Based Progress Estimates
H. Lee Moffitt Cancer Center, Tampa, FLBladder Cancer+1 MoreErdafitinib Intravesical Delivery System - Drug
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Bladder Cancer
  • Fibroblast Growth Factor Receptors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 8 Secondary · Reporting Duration: Cohorts 1 and 3: up to 6 months; Cohort 2 and 4: up to 8 weeks

Month 6
Plasma Concentration of Erdafitinib
Urine Concentration of Erdafitinib
Up to 28 days
Number of Participants with Dose-limiting Toxicity (DLT)
Year 5
Cohort 3: Complete Response (CR) Rate
Cohort 3: Duration of CR
Administration, Intravesical
Cohort 4: Pathological Complete Response (pCR) Rate
Cohort 4: Rate of downstaging to Less than (<) pT2
Cohorts 1 and 2: Recurrence-Free Survival (RFS)
Number of Participants with AEs by Severity
Number of Participants with Adverse Events (AEs)

Trial Safety

Safety Progress

1 of 3

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

Part 1: Dose Escalation
Experimental Group · 1 Intervention: Erdafitinib Intravesical Delivery System · Intervention Types: Drug
Part 2: Dose Expansion
Experimental Group · 1 Intervention: Erdafitinib Intravesical Delivery System · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: cohorts 1 and 3: up to 6 months; cohort 2 and 4: up to 8 weeks

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
933 Previous Clinical Trials
6,368,639 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
716 Previous Clinical Trials
3,950,780 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
How old are they?
18 - 65100.0%
What site did they apply to?
University of Southern California100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%

Frequently Asked Questions

Are there still openings available to participate in this experiment?

"Yes, based on the 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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.