A Phase II Clinical Trial of Dasatinib in Patients With Metastatic Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Progression-free Survival (PFS) Rate at 4 Months
研究概览
简要总结
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with stage IV pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- To evaluate the 4-month progression-free survival (PFS) rate in patients with stage IV pancreatic cancer treated with dasatinib.
Secondary
- To evaluate the response rate (complete and partial response) in patients treated with this drug.
- To evaluate the median PFS and overall survival of patients treated with this drug.
- To study the toxicities and tolerability of this drug in these patients.
- To evaluate the impact of this drug on quality of life measures.
- To evaluate the impact of this drug on Src and FAK in peripheral blood mononuclear cells prior to and during treatment.
- To study the pre-treatment expression of various signaling molecules in the Src and STAT3 pathways and attempt to identify a relationship between these findings and the aggressiveness of the tumor or its response to treatment with dasatinib.
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 —（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
Dasatinib
Dasatinib 70 mg po bid (1 cycle=28 days)
干预措施: dasatinib (Drug)
Dasatinib
Dasatinib 70 mg po bid (1 cycle=28 days)
干预措施: immunoenzyme technique (Other)
Dasatinib
Dasatinib 70 mg po bid (1 cycle=28 days)
干预措施: immunohistochemistry staining method (Other)
Dasatinib
Dasatinib 70 mg po bid (1 cycle=28 days)
干预措施: laboratory biomarker analysis (Other)
Dasatinib
Dasatinib 70 mg po bid (1 cycle=28 days)
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Progression-free Survival (PFS) Rate at 4 Months
时间窗: Four months.
Progressive disease - appearance of one or more new lesions. Unequivocal progression of existing non-target lesions. Although a clear progression of non-target lesions only is exceptional, in such circumstances, the opinion of the treating physician should prevail and the progression status should be confirmed later on by a review panel (or study chair/primary investigator).
次要结局
- Response Rate(After every two cycles, up to 5 years)