NCT05567185CompletedPhase 1
A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer
A Phase 1 Study to Evaluate the Tolerability, Safety, and Pharmacokinetics of TAR-210 in Japanese Participants With Bladder Cancer and Selected FGFR Mutations or Fusions
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
The purpose of the study is to determine the tolerability of erdafitinib intravesical delivery system (TAR-210) in Japanese participants.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 5 (actual)
- First submitted
- 3 Oct 2022
- Start date
- 3 Mar 2023
- Primary completion date
- 11 Mar 2025
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Diseases
- Bladder cancer
- NCT number
- NCT05567185
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 5
- From 3 Mar 2023 to the primary completion date, 11 Mar 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with an fibroblast growth factor receptor (FGFR) inhibitor
- Participants with active bladder stones or history of bladder stones less than \[\< 6\] months prior to the start of study treatment
- Participants have concurrent or second malignancy other than the disease which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s); -Bladder post-void residual volume (PVR) \>350 mL after second voided urine, -Current central serous retinopathy or retinal pigment epithelial detachment of any-grade
Other
- Histologically confirmed muscle-invasive (T2 or higher stage) urothelial carcinoma of the bladder.
- Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe placement, indwelling use, or removal of erdafitinib intravesical delivery system
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St Marianna University Hospital Coordinator of this site? Confirm its status | Kanagawa | Japan | Unknown status |
| Osaka International Cancer Institute Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Toyama University Hospital Coordinator of this site? Confirm its status | Toyama | Japan | Unknown status |
| University of Tsukuba Hospital Coordinator of this site? Confirm its status | Tsukuba | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.