NCT05567185进行中（未招募）1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 5
- 试验地点
- 6
- 主要终点
- Number of Participants with Dose-limiting Toxicity (DLT)
研究概览
简要总结
The purpose of the study is to determine the tolerability of erdafitinib intravesical delivery system (TAR-210) in Japanese participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Dose Escalation: Erdafinitib Intravesical Delivery System
Experimental
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.
干预措施: Erdafitinib Intravesical Delivery System (Drug)
结局指标
主要结局
Number of Participants with Dose-limiting Toxicity (DLT)
时间窗: 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.
次要结局
- Urine Concentration of Erdafitinib(Up to 180 days)
- Number of Participants with Adverse Events (AEs)(Up to 3 years 10 months)
- Number of Participants with AEs by Severity(Up to 3 years 10 months)
- Plasma Concentration of Erdafitinib(Up to 180 days)
研究者
研究点 (6)
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