NCT01339754已完成2 期
Salvage Therapy With Trabectedin in Metastatic Pancreatic Adenocarcinoma: A Single-Arm Phase II Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS) rate at 6 months
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well trabectedin works in treating patients with metastatic pancreatic cancer after first-line chemotherapy.
详细描述
OBJECTIVES:
Primary
- To assess the therapeutic activity of trabectedin, in terms of progression-free survival (PFS) rate at 6 months, in patients with metastatic pancreatic adenocarcinoma progressed after gemcitabine-containing first-line chemotherapy.
Secondary
- To assess the safety profile of this drug.
- To assess the response rate and response duration.
- To assess the overall survival of these patients.
- To assess the PFS rate at 9 and 18 weeks.
- To perform blood, plasma, and tumor tissue sampling for biological studies, in order to identify biomarkers predictive for resistance or sensitivity to trabectedin, and to characterize the impact of pharmacogenomic and pharmacokinetic profile on anti-tumor activity in translational research studies.
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 75 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
trabectedin
Experimental
1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression
干预措施: trabectedin (Drug)
结局指标
主要结局
Progression-free survival (PFS) rate at 6 months
时间窗: every 9 weeks
CT scan
次要结局
- Response rate and response duration(every 2 months)
- PFS rate at 9 and 18 weeks(every 9 weeks)
- Overall survival(every 3 weeks during therapy, every 2-3 months thereafter)
- Identify biomarkers predictive for resistance or sensitivity to trabectedin(at trial start)
- Safety profile(every 3 weeks)
- Impact of pharmacogenomic and pharmacokinetic profile on anti-tumor activity(based on a pre-definid sample collection schedule)
研究者
研究点 (1)
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