A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer

Study Overview
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Brief Summary
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The purpose of the study is to determine the tolerability of erdafitinib intravesical delivery system (TAR-210) in Japanese participants.

Official Title
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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

Conditions
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Urinary Bladder Neoplasms, Receptors, Fibroblast Growth Factor

Intervention / Treatment
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* Drug: Erdafitinib Intravesical Delivery System


Participation Criteria
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Eligibility Criteria
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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 papillary disease after prior therapy that meet either one: a. Recurrence of high-risk non-muscle invasive bladder cancer (NMIBC) papillary disease (high-grade Ta or any-grade T1, concomitant carcinoma in situ (CIS) is allowed) 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 papillary disease (any-grade Ta/T1, concomitant CIS is allowed) after prior BCG, refusing or ineligible for RC and considering no other effective treatment options. c. Recurrence of intermediate-risk NMIBC (low grade Ta) after intravesical chemotherapy, 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Escalation: Erdafinitib Intravesical Delivery System<br>Participants with bladder cancer and fibroblast growth factor receptor (FGFR) mutations or fusions will receive erdafitinib intravesical delivery system and study will evaluate 2 dose levels of erdafitinib. Participants with a complete response (CR) may continue to receive treatment up to a duration of 1 year as long as there is no disease recurrence or progression, intolerable toxicity or withdrawal of consent. | Drug: Erdafitinib Intravesical Delivery System<br>* Erdafitinib intravesical delivery system will be administered.<br>* Other names: JNJ-42756493;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Dose-limiting Toxicity (DLT) | 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. | Up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentration of Erdafitinib | Plasma concentration of erdafitinib will be reported. | Up to 180 days | 
| Urine Concentration of Erdafitinib | Urine concentration of erdafitinib will be reported. | Up to 180 days | 
| Number of Participants with Adverse Events (AEs) | 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. | Up to 3 years 10 months | 
| Number of Participants with AEs by Severity | 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. | Up to 3 years 10 months |