Biomarker Research Study for Patients With FGFR-Mutant Bladder Cancer Receiving Erdafitinib (NCT05052372) | Clinical Trial Compass
TerminatedNot Applicable
Biomarker Research Study for Patients With FGFR-Mutant Bladder Cancer Receiving Erdafitinib
Stopped: Sponsor request to terminate study due to enrollment numbers
United States2 participantsStarted 2021-11-21
Plain-language summary
Bladder cancers are associated with genetic mutations that are present in the patient's bladder or urothelium, the lining of the lower urinary tract. Fibroblast growth factor (FGFR) alterations are present in approximately one in five patients with recurrent and refractory bladder cancer.
This study will collect biomarker data from subjects receiving erdafitinib to further investigate the relationship between treatment with erdafitinib and clinical response, progression, and/or genetic alterations.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects with a diagnosis of locally advanced or metastatic bladder cancer
* Documented proof of an FGFR alteration according to a CLIA-based test
* Subjects who are receiving or will receive erdafitinib as their standard medical therapy as a monotherapy or in combination
* Age greater than or equal to 18 years.
* Subject is a resident of or seeking care in the United States
* Able and willing to provide informed consent to this biomarker study
* Informed consent obtained for the XCELSIOR longitudinal outcomes registry (NCT03793088).
Exclusion Criteria:
* Subjects younger than 18 years of age
* Subjects unwilling or unable to provide informed consent
* Subjects that are not receiving treatment in the United States or US Territories
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Relationship between treatment with erdafitinib and clinical response
Timeframe: Time to progression will vary for each patient. We expect most patients to progress on erdafitinib within 2 to 15 months from baseline