Erdafitinib for Bladder Cancer

CUROS - Uberörtliche urologische Gemeinschaftspraxis, Wesseling, Germany
Bladder CancerErdafitinib - Drug
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Bladder Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 14 Secondary · Reporting Duration: Up to 4 years

Year 4
Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24
Change from Baseline in EuroQol European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L)
Change from Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) -C30
Change from Baseline in Patient's Global Impression of Severity (of cancer) (PGIS)
Year 2
Change from Baseline in Patient's Global Impression of Change (of cancer) (PGIC)
Day 28
Plasma Concentration of Erdafitinib
Month 6
Recurrence-Free Survival
Up to 4 years
Disease-Specific Survival
Number of Participants with Adverse events
Overall Survival
RFS by Central Histopathologic Review
Recurrence-Free Survival (RFS)
Recurrence-Free Survival 2 (RFS2)
Time to Disease Worsening
Time to Progression

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

4 Treatment Groups

Cohort 1: Investigators Choice
1 of 4
Cohort 1: Erdafitinib
1 of 4
Cohort 2
1 of 4
Cohort 3
1 of 4

Active Control

Experimental Treatment

105 Total Participants · 4 Treatment Groups

Primary Treatment: Erdafitinib · No Placebo Group · Phase 2

Cohort 1: Erdafitinib
Experimental Group · 1 Intervention: Erdafitinib · Intervention Types: Drug
Cohort 2
Experimental Group · 1 Intervention: Erdafitinib · Intervention Types: Drug
Cohort 3
Experimental Group · 1 Intervention: Erdafitinib · Intervention Types: Drug
Cohort 1: Investigators ChoiceActiveComparator Group · 2 Interventions: Investigator Choice (Gemcitabine), Investigator Choice (Mitomycin C) · Intervention Types: Drug, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 years

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
940 Previous Clinical Trials
6,369,998 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
722 Previous Clinical Trials
3,952,156 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

Are patients still being enrolled in this research study?

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

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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

"That is accurate. The 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." - 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.