A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer (NCT05567185) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer
Japan5 participantsStarted 2023-03-03
Plain-language summary
The purpose of the study is to determine the tolerability of erdafitinib intravesical delivery system (TAR-210) in Japanese participants.
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:
* Histologically confirmed non-muscle-invasive urothelial carcinoma of the bladder
* All visible tumors must be completely resected prior to the start of study treatment and documented on screening cystoscopy
* Confirmed recurrence of non-muscle invasive bladder cancer (NMIBC) after prior therapy that meet either one: a. Recurrence of high-risk NMIBC (high-grade Ta or any-grade T1) within 12 months after adequate Bacillus Calmette-Guerin (BCG), or any-grade T1 within 3 months after 1st induction course, refusing or ineligible for radical cystectomy (RC). b. Recurrence of intermediate- or high-risk NMIBC (any-grade Ta/T1) after prior BCG regardless of the timing of recurrence, refusing or ineligible for RC and considering no other effective treatment options. c. Recurrence of intermediate-risk NMIBC (low grade Ta) after intravesical chemotherapy including maintenance therapy following a single dose after operation, no other effective intravesical chemotherapy is available and refusing BCG treatment
* At least 1 of the study protocol defined activating fibroblast growth factor receptors (FGFR) mutation or fusion, as determined by local or central testing using either tumor tissue or urine sample collected prior to trans urethral resection of bladder tumour (TURBT)
* Eastern Cooperative Oncology Group (ECOG) performance status score of less than or equal to (\<=) 2
Exclusion Criteria:
* Histologically confirmed muscle-invasive (T2 or higher stage) urotheli…
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.
1This trial is specifically testing an intravesical delivery system, meaning the drug is placed directly into the bladder rather than taken by mouth or injected — can you explain how that approach would work in practice for me, and what the procedure would involve?
2Since this is a Phase 1 trial focused on measuring dose-limiting toxicities, it's primarily designed to find a safe dose rather than prove the treatment works — given that, how does the potential benefit weigh against the unknown risks for someone in my situation?
3The trial is listed as 'active, not recruiting,' which suggests they are no longer enrolling new participants — does that mean this option is closed to me, and are there similar trials I could still join?
4This trial is specifically enrolling Japanese participants — could you help me understand whether my background makes me eligible, and whether results from this study would be relevant to my care even if I'm not part of it?
5Are there standard treatments for my type of bladder cancer that I should consider first before looking at early-phase trials like this one, and how would joining or not joining a trial like this affect my overall treatment plan?
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
Number of Participants with Dose-limiting Toxicity (DLT)