NCT00910741已完成1 期
Phase I/II Study of the Combination Therapy With NC-6004 and Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer in Asian Countries
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Incidence of DLT and Response rate
研究概览
简要总结
The purpose of this study is to determine the recommended dose of NC-6004 according to the dose-limiting toxicity (DLT) in combination with Gemcitabine, and to assess the efficacy, safety and tolerability.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chemo-naive, advanced pancreatic cancer
- •Nonresectable, histologically or cytologically confirmed, locally advanced or metastatic pancreatic cancer
排除标准
- •Pulmonary fibrosis or interstitial pneumonia
- •Marked pleural effusion or ascites above Grade 2
- •Severe drug hypersensitivity
- •Metastasis to the central nervous system and brain
研究组 & 干预措施
Nanoplatin
Experimental
Nanoplatin (NC-6004) had to be administered once every 3 weeks, on Day 1, Day 22 and Day 43 etc.
Gemcitabine had to be administered to every patient 2 times on Day 1 and Day 8 every 3 weeks after the infusion of Nanoplatin (NC-6004).
干预措施: Nanoplatin (NC-6004) and Gemcitabine (Drug)
结局指标
主要结局
Incidence of DLT and Response rate
时间窗: DLT is evaluated for 3 weeks o the treatment, Response rate is evaluated at 7,13,19 and 25weeks of the treatment
次要结局
- Overall survival(1.5 year)
研究者
研究点 (5)
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