NCT00536770暂停2 期
A Randomized Phase 2 Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Subjects With Advanced Pancreatic Adenocarcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- Novacea
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Overall survival rate at 6 months
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of an investigational study drug DN-101 (calcitriol) when given in combination with gemcitabine ± erlotinib in the treatment of pancreatic cancer.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 diagnosis of locally advanced and unresectable, or metastatic pancreatic cancer
- •Performance status 0, 1,or 2
- •Adequate bone marrow, renal and hepatic function
排除标准
- •Prior chemotherapy or radiation therapy for pancreatic cancer
- •Prior treatment for other cancers in last 6 months
- •Cancer of the brain or spine
- •Active uncontrolled infection
- •Hypercalcemia
研究组 & 干预措施
B
Placebo Comparator
Placebo + gemcitabine + erlotinib
干预措施: placebo + gemcitabine + erlotinib (Drug)
A
Placebo Comparator
Placebo + gemcitabine
干预措施: Placebo + gemcitabine (Drug)
C
Active Comparator
DN-101 + gemcitabine
干预措施: calcitriol + gemcitabine (Drug)
D
Active Comparator
DN-101 + gemcitabine + erlotinib
干预措施: calcitriol + gemcitabine + erlotinib (Drug)
结局指标
主要结局
Overall survival rate at 6 months
次要结局
- Duration of overall survival
- Objective response rate
- Duration of progression free survival
研究者
研究点 (1)
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