A Phase II Study of PEP02 as a Second Line Therapy for Patients With Metastatic Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 3
- 主要终点
- Survival Rate
研究概览
简要总结
The purpose of this study is to see the effect of PEP02 in the treatment of metastatic pancreatic cancer.
详细描述
Gemcitabine monotherapy or a gemcitabine-based combination regimen is the standard first line therapy for advanced pancreatic cancer. After disease progression, there is no standard treatment available. In animal studies and a previous phase I trial, PEP02 has shown anti-tumor activity and preliminary efficacy in pancreatic cancer. In addition, a phase II study of free-form irinotecan single agent has already shown encouraging activity as second-line treatment for patients with advanced pancreatic cancer refractory to gemcitabine. The liposome formulation of PEP02 theoretically has therapeutic advantages over free-form irinotecan, such as site-specific delivery and extended release of drug. Hence PEP02 may be able to provide better efficacy than free-form irinotecan.
The primary purpose of this phase II study is to evaluate the activity of PEP02 as a second-line therapy in patients with metastatic pancreatic cancer failed to gemcitabine treatment. The primary goal is to measure the 3-month survival rate. An optimal Simon's 2-stage design will be used for this exploratory phase II study.
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
- •Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
- •Metastatic disease
- •Documented disease progression after treatment with 1 line of prior gemcitabine-based regimen
- •Karnofsky performance status equal or more than 70
排除标准
- •With active CNS metastases
- •With clinically significant gastrointestinal disorder (e.g., bleeding, inflammation, occlusion, or diarrhea > grade 1)
- •Major surgery or radiotherapy within 4 weeks
- •Prior participation in any investigational drug study within 4 weeks
- •With prior irinotecan treatment
研究组 & 干预措施
PEP02
Liposome Irinotecan
干预措施: PEP02 (Drug)
结局指标
主要结局
Survival Rate
时间窗: 3-month
Survival rate at 3 months
次要结局
- toxicities(36 months)
- other efficacy endpoints(6-8 weeks)
- pharmacogenetics(24 months)