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 range18 Years
SexALL
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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…
What they're measuring
1
Number of Participants with Dose-limiting Toxicity (DLT)