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.
- Bladder Cancer
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 14 Secondary · Reporting Duration: Up to 4 years
Trial Safety
Phase-Based Safety
Awards & Highlights
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
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Han MA, Maisch P, Jung JH, Hwang JE, Narayan V, Cleves A, Hwang EC, Dahm P. Intravesical gemcitabine for non-muscle invasive bladder cancer. Cochrane Database Syst Rev. 2021 Jun 14;6:CD009294. doi: 10.1002/14651858.CD009294.pub3.
- Han MA, Maisch P, Jung JH, Hwang JE, Narayan V, Cleves A, Hwang EC, Dahm P. Intravesical gemcitabine for non-muscle invasive bladder cancer. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD009294. doi: 10.1002/14651858.CD009294.pub3.
- 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.
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
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." - Anonymous Online Contributor
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
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
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
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." - Anonymous Online Contributor