Clinical trial NCT05567185: A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Urinary Bladder Neoplasms
Receptors, Fibroblast Growth Factor
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2022-10-05
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Dose-limiting Toxicity (DLT)
timeFrame: Up to 28 days
Secondary outcomes:
measure: Plasma Concentration of Erdafitinib
timeFrame: Up to 180 days
measure: Urine Concentration of Erdafitinib
timeFrame: Up to 180 days
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 3 years 10 months
measure: Number of Participants with AEs by Severity
timeFrame: Up to 3 years 10 months
Other outcomes:
Locations:
city: Kanagawa
country: Japan
facility: St Marianna University Hospital
city: Osaka City
country: Japan
facility: Osaka International Cancer Institute
city: Toyama-shi
country: Japan
facility: Toyama University Hospital
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: