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 - TAR-210

Fujikawa Ei0 个研究点目标入组 6 人开始时间: 2022年11月29日最近更新: 2024年1月22日

试验速览

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•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 papillary disease after prior therapy that meet either one: a. Recurrence of high-risk non-muscle invasive bladder cancer (NMIBC) papillary disease (high-grade Ta or any-grade T1, concomitant carcinoma in situ (CIS) is allowed) 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 papillary disease (any-grade Ta/T1, concomitant CIS is allowed) after prior BCG, refusing or ineligible for RC and considering no other effective treatment options. c. Recurrence of intermediate-risk NMIBC (low grade Ta) after intravesical chemotherapy, no other effective intravesical chemotherapy is available and refusing BCG treatment
•- At least 1 of the study protocol defined activating tumor 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

•- 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
•- Toxicity from prior anticancer therapy has not resolved to baseline levels or to grade less than or equal to [<=] 1 (except alopecia, vitiligo, peripheral neuropathy, or endocrinopathies that are stable on hormone replacement, which may be grade 2)
•- 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

发起方

Fujikawa Ei