A Phase I/II Study of AZD0530 in Combination With Gemcitabine in Patients With Advanced Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Response (complete [CR] and partial response [PR] or stable disease [SD]) at 8 weeks
研究概览
简要总结
RATIONALE: AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving AZD0530 together with gemcitabine may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of AZD0530 when given together with gemcitabine and to see how well they work in treating patients with locally advanced or metastatic pancreatic cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Phase I
- Determine the maximum tolerated dose of AZD0530 when given in combination with gemcitabine in patients with unresectable, locally advanced or metastatic pancreatic cancer.
- Determine the safety and tolerability of this regimen in these patients.
- Determine toxicity profile and dose-limiting toxicity of this regimen in these patients.
- Determine pharmacokinetic profile of this regimen in these patients.
- Correlate the toxicity profile with the pharmacokinetics of this regimen in these patients.
Phase II
- Determine the objective response rate (partial and complete response) and prolonged stable disease rate in patients treated with this regimen.
- Determine the median survival, 1-year survival, response or stable disease duration, time to disease progression, clinical benefit response, and progression-free survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Correlate changes in serum CTX levels (post-treatment vs baseline) with response and other clinical outcomes in patients treated with this regimen.
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 120 Years（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
AZD0530 + Gemcitabine
干预措施: AZD0530 (Drug)
AZD0530 + Gemcitabine
干预措施: gemcitabine hydrochloride (Drug)
结局指标
主要结局
Response (complete [CR] and partial response [PR] or stable disease [SD]) at 8 weeks
时间窗: 4 years
Response is assessed every other cycle and will be reported on at final analysis
次要结局
- Toxicity(4 years)