Receptors, Fibroblast Growth Factor, Urinary Bladder Neoplasms
Conditions
Brief summary
The purpose of the study is to determine the tolerability of erdafitinib intravesical delivery system (TAR-210) in Japanese participants.
Interventions
Erdafitinib intravesical delivery system will be administered.
Sponsors
Janssen Pharmaceutical K.K.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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) urothelial carcinoma of the bladder. * Prior treatment with an fibroblast growth factor receptor (FGFR) inhibitor * 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Dose-limiting Toxicity (DLT) | Up to 28 days | Number of participants with DLT will be assessed. The DLTs are specific adverse events related to erdafitinib intravesical delivery system and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration of Erdafitinib | Up to 180 days | Plasma concentration of erdafitinib will be reported. |
| Urine Concentration of Erdafitinib | Up to 180 days | Urine concentration of erdafitinib will be reported. |
| Number of Participants with Adverse Events (AEs) | Up to 3 years 10 months | An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
| Number of Participants with AEs by Severity | Up to 3 years 10 months | Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. |
Countries
Japan
Contacts
STUDY_DIRECTORJanssen Pharmaceutical K.K., Japan Clinical Trial
Janssen Pharmaceutical K.K.
Outcome results
None listed