jRCT2031250084尚未招募不适用
A Phase 2, Open-Label Study to Evaluate the Safety and Anti-Tumor Activity of Intravesical Instillation of TARA-002 in Adults with High-Grade Non-Muscle Invasive Bladder Cancer (ADVANCED-2)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Incidence of high-grade Complete Response
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Male or female participants 18 years of age or older at the time of signing informed consent.
- •Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry.
- •Central histologic confirmation of high-grade non-muscle invasive CIS (plus or minus Ta/T1) with active disease
- •Participants with persistent or recurrent CIS (plus or minus Ta/T1) who are BCG unresponsive within 12 months of completion of adequate BCG therapy.
排除标准
- •Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory.
- •Predominant (defined as > 50%) adenocarcinoma, squamous cell carcinoma, or histological variants including plasmacytoid, sarcomatoid, or squamous components according to central review.
- •Concomitant prostatic or upper tract urothelial involvement per Investigator's assessment.
- •Nodal and metastatic disease are excluded if they existed at any time (whether present or in the past).
- •Any history of >= T2 bladder cancer that existed at any point in time in the participant's history.
结局指标
主要结局
Incidence of high-grade Complete Response
时间窗: any time
Incidence of high-grade Complete Response at any time according to central pathology after treatment with TARA-002
次要结局
- Duration of high-grade Complete Response rate(Months 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60)
- High-grade Complete Response rate(Months 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60)
- Duration of Complete Response
- Complete Response rate(Months 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60)
- Progression free survival
- Disease-specific progression free survival
- Overall survival
- Disease specific survival
- Time to cystectomy
- Time to recurrence delayed cystectomy
- Time to progression
- Time to disease worsening
- Incidence and severity of AEs, TEAEs, SAEs and TESAEs
- Change from baseline in urine pharmacodynamic biomarker levels
- Quality of Life based on the EORTC questionnaire QLQ-NMIBC24
- Quality of Life based on the EORTC questionnaire QLQ-C30
研究者
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