NCT01158287已完成2 期
Phase II Study of Single Agent Sorafenib in the Treatment of Relapsed Esophageal/Gastric Adenocarcinoma in Platinum Pre-Treated Patients
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
- 54
- 试验地点
- 8
- 主要终点
- Disease control rate after 4 months
研究概览
简要总结
RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sorafenib tosylate works in treating patients with relapsed esophageal cancer and/or stomach cancer.
详细描述
OBJECTIVES:
Primary
- To determine the disease control rate (complete response, partial response, and stable disease) of sorafenib tosylate after 4 months in patients with relapsed esophageal or gastric adenocarcinoma previously treated with platinum-based chemotherapy.
Secondary
- To determine the progression-free survival of patients treated with this drug.
- To determine the overall survival of patients treated with this drug.
- To determine the time to tumor progression in patients treated with this drug.
- To determine the objective response rate in patients treated with this drug.
- To determine the tolerability and toxicity in patients treated with this drug.
- To assess biomarkers associated with response/resistance to therapy. (exploratory)
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
Sorafenib 400mg bd, p.o, continuously
Experimental
干预措施: sorafenib tosylate (Drug)
Sorafenib 400mg bd, p.o, continuously
Experimental
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Disease control rate after 4 months
时间窗: After 4 months of treatment
次要结局
- Progression-free survival(Ongoing)
- Overall survival(Ongoing)
- Time to tumor progression(Ongoing)
- Objective response rate(Response would be assessed by appropriate imaging (e.g. CT) every 8 weeks.)
- Tolerability and toxicity(Ongoing for duration of treatment and 30 day follow up.)
研究者
研究点 (8)
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