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NCT Number: NCT05567185

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Urinary Bladder Neoplasms Acrocephalosyndactylia Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Craniosynostoses Dysostoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Limb Deformities, Congenital Male Urogenital Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Neoplasms Neoplasms by Site Receptors, Fibroblast Growth Factor Syndactyly Synostosis Urinary Bladder Diseases Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

St Marianna University Hospital, Kanagawa, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erdafitinib Intravesical Delivery System

Drug

Erdafitinib intravesical delivery system will be administered.

Other names: JNJ-42756493

Primary outcomes

  1. Number of Participants with Dose-limiting Toxicity (DLT)

    Time frame: 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 outcomes

  1. Plasma Concentration of Erdafitinib

    Time frame: Up to 180 days

    Plasma concentration of erdafitinib will be reported.

  2. Urine Concentration of Erdafitinib

    Time frame: Up to 180 days

    Urine concentration of erdafitinib will be reported.

  3. Number of Participants with Adverse Events (AEs)

    Time frame: 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.

  4. Number of Participants with AEs by Severity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Janssen Pharmaceutical K.K.

Industry

Registry information

Official study 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

Acronym: TAR-210

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 5, 2022
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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