An Open-Label, Single-Arm, Multi-center Phase II Study to Evaluate the Efficacy and Safety of TLC388 in Patients With Advanced/Metastatic Renal Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 5
- 主要终点
- Non-progression disease (non-PD) rate at the end of cycle 6
研究概览
简要总结
INVESTIGATIONAL PRODUCT:
TLC388 (Lipotecan*) *Lipotecan is a drug product of TLC388 HCl.
PHASE OF DEVELOPMENT:
Phase II
No. OF PATIENTS:
Approximately 40 (Stage I: 15 evaluable patients, Stage II: 25 evaluable patients)
STUDY OBJECTIVES:
Primary
• To evaluate non-progression disease (non-PD) rate at the end of cycle 6
Secondary
- To evaluate progression free survival (PFS)
- To evaluate overall survival (OS)
- To evaluate the duration of non-PD
- To evaluate objective response rate (ORR; where ORR= CR+PR) and duration
- To evaluate the safety profile of TLC388
- To evaluate change in health-related quality of life (HRQOL) at the end of cycle 6
STUDY DESIGN:
This is a Phase II, open-label, single-arm, multi-centre study to evaluate TLC388 monotherapy in patients with locally advanced and/or metastatic renal cell carcinoma (RCC).
详细描述
A Phase II, open-label, single-arm, multi-center study to evaluate TLC388 monotherapy in patients with locally advanced and/or metastatic RCC. The study consisted of a Screening/Baseline Period, a Treatment Period and a post-treatment Follow-Up Period for PFS and OS.
Patients were to be recruited at two stages. Stage I recruited 15 evaluable patients, who had completed at least 2 cycles of treatment with one tumor assessment. If ≤ 5 patients did not develop PD at the end of cycle 6 per RECIST, no patients were to be recruited for Stage II and the study was to be closed. If > 5 patients did not develop PD at the end of cycle 6, a total of 40 evaluable patients (additional 25 evaluable patients for Stage II) were to be recruited thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lipotecan, injection for chemotherapy
Patients receive TLC388 (50 mg/m2) given as a 30-minute IV infusion, on Days 1, 8, and 15 of a 28-day cycle.
干预措施: Lipotecan (Drug)
结局指标
主要结局
Non-progression disease (non-PD) rate at the end of cycle 6
时间窗: 6 months
Non-progression disease rate after cycle 6
次要结局
- Change in health-related quality of life (HRQOL) at the end of cycle 6(6 months)
- Progression free survival (PFS)(3 years)
- Overall survival (OS)(3 years)
- Safety profile of TLC388(3 years)
- Duration of non-PD(3 years)
- Objective response rate (ORR; where ORR= CR+PR) and duration(3 years)