NCT00377936已完成2 期
A Controlled, Randomized, Open Label Phase II Trial to Evaluate Safety and Efficacy of a 1st Line Combination Treatment With Weekly Infusions of Gemcitabine and Twice Weekly Administration of Lipid Complexed Paclitaxel (EndoTAG-1) in Three Dose Levels Compared With Gemcitabine Monotherapy in Patients With Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- MediGene
- 入组人数
- 212
- 主要终点
- Progression free survival
研究概览
简要总结
The intention of this trial is to evaluate safety and efficacy of a combination treatment of EndoTAG-1 with Gemcitabine versus Gemcitabine monotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Inoperable adenocarcinoma of the pancreas
- •Histologic or cytologic confirmation
- •At least 18 years of age
排除标准
- •Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrollment
- •Major surgery within 4 weeks prior to enrollment
- •Major cardiovascular disease
研究组 & 干预措施
1
Active Comparator
Gemcitabine
干预措施: Gemcitabine alone (Drug)
2
Experimental
EndoTag-1 + Gemcitabine
干预措施: EndoTAG-1 and Gemcitabine (Drug)
3
Experimental
EndoTag-1 + Gemcitabine
干预措施: EndoTAG-1 and Gemcitabine (Drug)
4
Experimental
EndoTag-1 + Gemcitabine
干预措施: EndoTAG-1 and Gemcitabine (Drug)
结局指标
主要结局
Progression free survival
时间窗: Median
6-month-survival-rate
时间窗: 6 Months
Overall survival
时间窗: Median
次要结局
- Incidence and percentage of patients with Adverse Events(28 days after last patient out)
- Number of clinically significant abnormal laboratory values(Last patient out)
研究者
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