NCT00568750已完成2 期
Dasatinib First-Line Treatment in Gastrointestinal Stromal Tumors. A Multi Center 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
- 47
- 试验地点
- 18
- 主要终点
- Response as assessed by fusion PET/CT scan according to EORTC PET Study Group criteria
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 as first-line therapy in treating patients with gastrointestinal stromal tumors.
详细描述
OBJECTIVES:
Primary
- To determine the efficacy of dasatinib as assessed by fusion PET/CT scan in patients with gastrointestinal stromal tumors.
Secondary
- To determine the efficacy and safety of dasatinib in these patients.
- To correlate the efficacy of dasatinib with KIT and PDGFR mutational status.
- To correlate the efficacy and safety of dasatinib with dasatinib drug exposure.
- To determine the efficacy of second-line treatment with another TK-inhibitor.
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
Dasatinib
Experimental
干预措施: dasatinib (Drug)
结局指标
主要结局
Response as assessed by fusion PET/CT scan according to EORTC PET Study Group criteria
时间窗: at 4 weeks compared to baseline
次要结局
- Time to progression(calculated from registration until progression or death due to tumor)
- Best response as assessed by CT scan/MRI(according to RECIST criteria)
- Progression-free survival(calculated from registration until progression or death)
- Time to treatment failure(calculated from registration until premature trial treatment termination due to any reason)
- Adverse drug reactions according to NCI CTCAE v3.0(Tolerability will be assessed based on the frequency and severity of Adverse Drug Reactions (ADR) coded according to NCI CTCAE v3.0.)
- Clinical benefit(Clinical benefit is defined as CR, PR, or as SD lasting at least 12 weeks, determined according to RECIST)
- Best response as assessed by fusion PET/CT scan(at 4 weeks)
- Overall survival(Overall survival will be calculated from registration until death or last follow-up, up to 5 years.)
研究者
研究点 (18)
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