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Tyrosine Kinase Inhibitor
Erdafitinib Delivery System for Bladder Cancer
Phase 1
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cohorts 1, 3 and 5: up to 6 months; cohort 2 and 4: up to 8 weeks
Awards & highlights
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.
Who is the study for?
This trial is for people with recurrent bladder cancer that hasn't spread into muscle or has just started to. They must have a specific genetic change in their tumor and may or may not have had BCG therapy, depending on the group they're placed in. Surgery should be an option for some participants. Those who've had recent pelvic radiation, certain bladder conditions, permanent urinary catheters, or previous FGFR inhibitor treatments can't join.Check my eligibility
What is being tested?
The study is testing Erdafitinib Intravesical Delivery System directly applied inside the bladder. The first part of the trial will find the best dose to use while the second part checks how safe it is at that dose.See study design
What are the potential side effects?
While specific side effects aren't listed here, intravesical therapies can generally cause discomfort during administration, increased frequency of urination, pain when urinating, blood in urine and potential risk of infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cohorts 1, 3 and 5: up to 6 months; cohort 2 and 4: up to 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cohorts 1, 3 and 5: up to 6 months; cohort 2 and 4: up to 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with AEs by Severity
Number of Participants with Adverse Events (AEs)
Number of Participants with Dose-limiting Toxicity (DLT)
Secondary outcome measures
Cohort 3 and 5: Complete Response (CR) Rate
Cohort 3 and 5: Duration of CR
Administration, Intravesical
+5 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Part 3: RP2D Dose ExpansionExperimental Treatment1 Intervention
Participants in 2 of the disease-specific NMIBC cohorts (cohorts 1 and 3) may be enrolled at RP2D to determine the safety, evaluate PK and preliminary clinical activity.
Group II: Part 2: Dose ExpansionExperimental Treatment1 Intervention
Participants in each of 5 disease-specific NMIBC or MIBC cohorts may be enrolled at one or more dose levels that have been determined to be safe in Part 1.
Group III: Part 1: Dose EscalationExperimental Treatment1 Intervention
Participants with recurrent, bacillus Calmette-Guerin (BCG)-experienced high risk papillary-only Non-Muscle-Invasive Bladder Cancer (NMIBC), refusing or ineligible for radical cystectomy or with recurrent, intermediate-risk NMIBC will receive Erdafitinib Intravesical Delivery System. The dose will be escalated to determine preliminary recommended phase 2 dose(s) (RP2D[s]) for Part 2.
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Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,196 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,793 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I use a catheter for urination.I have bladder cancer that has spread to nearby organs.My bladder cancer has grown into the muscle or has come back but not in the muscle.I had pelvic radiotherapy less than 6 months ago or have no bladder issues from treatment over 6 months ago.I am willing and meet the requirements for radical cystectomy.I have been treated with a medication targeting FGFR before.I have either been treated with BCG, couldn't get it due to unavailability, or stopped it early due to side effects.My tumor has an FGFR mutation or fusion confirmed by approved tests.I am not willing or cannot undergo major bladder surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2: Dose Expansion
- Group 2: Part 3: RP2D Dose Expansion
- Group 3: Part 1: Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
University of Southern California
What portion of applicants met pre-screening criteria?
Did not meet criteria
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