NCT00254267已完成2 期
An Open-label Phase 2 Study of AMG 706 in Japanese Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs) Who Developed Progressive Disease or Relapsed While on Imatinib Mesylate
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 35
- 主要终点
- The objective response rate as assessed by modified RECIST
研究概览
简要总结
The purpose of the study is to evaluate the safety and efficacy of AMG 706 in patients with gastrointestinal stromal tumor that have not been controlled while taking imatinib mesylate.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of histological confirmed GIST
- •Had prior imatinib mesylate therapy
- •Has at least 1 measurable leasion by modified RECIST
排除标准
- •Central nervous system tumor involvement requiring treatment
- •History of myocardial infraction
- •Uncontrolled hypertension
研究组 & 干预措施
Arm One
Experimental
AMG 706 125mg, oral, once a day
干预措施: AMG 706 (Drug)
结局指标
主要结局
The objective response rate as assessed by modified RECIST
时间窗: Every 8 weeks
次要结局
- Duration of response, progression-free survival, time to response, overall survival, PK and safety profile(imaging, every 8 weeks; survival, every 6 months; PK, Days 1,15, 29, 43, 57, every 2 weeks in week 9 to 16, and every 4 weeks thereafter;)
研究者
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