NCT06877676Approved For Marketing不适用
Pre-Approval Access US Intermediate Size Expanded Access Protocol for TAR-200 Treating Physician Use
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
研究概览
简要总结
The purpose of this pre-approval access program is to provide access to TAR-200 prior to its marketing authorization for the treatment of participant(s) with high-risk non-muscle invasive bladder cancer (HR-NMIBC).
研究设计
- 研究类型
- Expanded Access
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
- •Participant has exhausted all clinically appropriate alternative forms of treatment and is not eligible for, or does not have access to, a clinical trial
- •Histologically confirmed diagnosis of persistent or recurrent high-risk non-muscle-invasive bladder cancer (HR-NMIBC), carcinoma in situ (CIS) (OR Tis) with or without papillary disease (T1, high-grade Ta), within 12 months of completion of the last dose of BCG therapy, in participants who have received adequate Bacillus Calmette-Guérin (BCG)
- •All visible papillary disease must be fully resected (absent) prior to initiation of treatment
- •Participants must be ineligible for or have elected not to undergo Radical Cystectomy (RC)
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2
排除标准
- •Presence or history of histologically confirmed, muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, and/or Stage IV)
- •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 TAR-
- •Participants with tumors involving the prostatic urethra in men will be excluded
- •Evidence of bladder perforation during diagnostic cystoscopy
- •A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (>4000 mL)
- •Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than HR-NMIBC
研究者
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