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Tyrosine Kinase Inhibitor

Erdafitinib vs Chemotherapy for Bladder Cancer

Phase 2

Waitlist Available

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

Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-1

Histologically confirmed, recurrent, non-muscle-invasive urothelial carcinoma of the bladder. Variant pathology are allowed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

Study Summary

This trial will compare recurrence-free survival rates for patients with high-risk bladder cancer who have FGFR mutations or fusions and have had a recurrence after BCG therapy, between those who receive erdafitinib and those who receive the investigator's choice of standard therapy.

Who is the study for?

This trial is for adults with high-risk non-muscle-invasive bladder cancer that has returned after BCG therapy. Participants must have specific FGFR mutations or fusions, be unable to undergo cystectomy, and have good performance status (ECOG 0-1). They need proper organ function and a negative pregnancy test for women of childbearing potential.Check my eligibility

What is being tested?

The study compares the effectiveness of Erdafitinib against standard intravesical chemotherapy drugs like Gemcitabine or Mitomycin C in preventing cancer recurrence. It targets patients whose bladder cancer harbors certain genetic changes and who didn't respond well to previous treatments.See study design

What are the potential side effects?

Erdafitinib may cause side effects such as mouth sores, nail changes, skin rash, dry skin, change in hair color, tiredness, diarrhea and loss of appetite. Standard chemotherapy can lead to irritation inside the bladder, bleeding when urinating or increased frequency of urination.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My bladder cancer has come back and is not in the muscle.

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My bladder cancer did not respond to BCG therapy.

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My tumor has specific FGFR gene changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Recurrence-Free Survival (RFS)

Secondary outcome measures

Number of Participants with Adverse events

Overall Survival

Plasma Concentration of Erdafitinib

+2 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Cohort 3Experimental Treatment1 Intervention

Marker lesion study in intermediate-risk NMIBC presenting as papillary disease only. All enrolled participants will receive treatment with erdafitinib.

Group II: Cohort 2Experimental Treatment1 Intervention

Participants with high-risk, BCG- unresponsive NMIBC presenting as CIS with or without concurrent papillary tumor will receive treatment with erdafitinib.

Group III: Cohort 1: ErdafitinibExperimental Treatment1 Intervention

Participants with high-risk non-muscle-invasive bladder cancer (NMIBC) presenting as papillary tumor only (carcinoma in situ [CIS], absent), with disease recurrence after bacillus Calmette- Guerin (BCG) therapy will receive treatment with erdafitinib.

Group IV: Cohort 1: Investigators ChoiceActive Control2 Interventions

Participants with high-risk NMIBC presenting as papillary tumor only (CIS, absent), with disease recurrence after BCG therapy will receive the investigator's choice of either intravesical gemcitabine or intravesical mitomycin C (MMC) or hyperthermic MMC. Participants who are randomized to gemcitabine or MMC or hyperthermic MMC in Cohort 1 and demonstrate a recurrence via investigator disease assessment will have the opportunity to cross over to treatment with erdafitinib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Erdafitinib

2017

Completed Phase 2

~150

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,384,201 Total Patients Enrolled

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

745 Previous Clinical Trials

3,959,798 Total Patients Enrolled

Media Library

Erdafitinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04172675 — Phase 2

Bladder Cancer Research Study Groups: Cohort 2, Cohort 1: Investigators Choice, Cohort 1: Erdafitinib, Cohort 3

Bladder Cancer Clinical Trial 2023: Erdafitinib Highlights & Side Effects. Trial Name: NCT04172675 — Phase 2

Erdafitinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04172675 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other examples of Erdafitinib's use in a medical setting?

"At the moment, 517 different trials are investigating Erdafitinib. Of these live clinical trials, 148 have reached Phase 3. Though a great many of the trials for Erdafitinib originate from Woolloongabba, Queensland, there are 28,699 locations running trials for this medication globally."

Answered by AI

Are patients still being enrolled in this research study?

"Yes, this trial is still recruiting patients. According to the information available on clinicaltrials.gov, the trial was originally posted on February 28th 2020 and was last updated on November 3rd 2022."

Answered by AI

How does Erdafitinib's risk profile compare to other treatments?

"Erdafitinib's safety is based on Phase 2 clinical trial data, which only provides evidence of limited efficacy and safety."

Answered by AI

What ailments does Erdafitinib typically alleviate?

"Erdafitinib is most often used to treat small cell lung cancer. However, it has also been taken to effectively manage head and neck carcinoma, cervical cancers, and glaucoma."

Answered by AI

At how many hospitals is this research being conducted?

"The principal investigator for this research project is based out of Oregon Health & Science University. However, the study is also being conducted at The Ohio State University- James Cancer Hospital, Urological Research Network, and 15 other sites."

Answered by AI

How many people total will be included in this research project?

"That is accurate. The clinicaltrials.gov website has the latest information on this study, which was originally posted on February 28th 2020 and last edited on November 3rd 2020. They are looking for 105 participants total, with 15 sites currently recruiting."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

2020. "A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04172675.

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