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

Urinary Bladder Neoplasms Clinical Trial

— TAR-210  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05567185
• Other study ID #: CR109248
• Secondary ID: 42756493BLC1004
• Status: Recruiting
• Phase: Phase 1
• Start date: March 3, 2023
• Est. completion date: September 24, 2027

Study information

• Verified date: June 2024
• Source: Janssen Pharmaceutical K.K.
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: September 24, 2027
• Est. primary completion date: October 16, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Receptors, Fibroblast Growth Factor
• Urinary Bladder Neoplasms

Intervention

Drug:
• Erdafitinib Intravesical Delivery System
Erdafitinib intravesical delivery system will be administered.

Locations

Country	Name	City	State
Japan	St Marianna University Hospital	Kanagawa
Japan	Osaka International Cancer Institute	Osaka City
Japan	Toyama University Hospital	Toyama-shi
Japan	University of Tsukuba Hospital	Tsukuba

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutical K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Plasma Concentration of Erdafitinib	Plasma concentration of erdafitinib will be reported.	Up to 180 days
Secondary	Urine Concentration of Erdafitinib	Urine concentration of erdafitinib will be reported.	Up to 180 days
Secondary	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
Secondary	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