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

JRCT ID: jRCT2041220101

Registered date:29/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Urinary Bladder Neoplasms Receptors, Fibroblast Growth Factor
• Date of first enrollment: 31/10/2023
• Target sample size: 6
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: 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 Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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 Information

• Primary Sponsor: Fujikawa Ei
• Secondary ID(s): NCT05567185