NCT00998751已完成2 期
Phase 2 Study of Oral AB1010 in Non Pre-treated, Inoperable Patients With Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)
AB Science1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2005年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST)
研究概览
简要总结
The objective is to evaluate the efficacy and safety of AB1010 at 7.5 mg/kg/day in the treatment of non pre-treated, inoperable patients with locally advanced/metastatic GIST.
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
- •Male or Female patients, age >18
- •Life expectancy > 6 months
- •Histological proven, metastatic, or locally advanced and non-operable, non- pre-treated GIST.
- •Patients having never received any tyrosine kinase inhibitor, including as adjuvant therapy
- •C-Kit (CD117) positive tumors detected immuno-histochemically
- •Measurable tumor lesions with longest diameter >20 mm using conventional techniques or >10 mm with spiral CT scan
排除标准
- •Documented allergy to the similar drug of AB1010
- •Inadequate organ function
- •Patients with a history of any other malignancy
研究组 & 干预措施
masitinib (AB1010)
Experimental
oral masitinib 7.5 mg/kg/day
干预措施: oral masitinib (Drug)
结局指标
主要结局
Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST)
时间窗: 2 months
次要结局
- Progression Free Survival(until disease progression)
研究者
研究点 (1)
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