NL-OMON44774招募中3 期
A prospective, multicenter, randomised, open-label, active controlled, 2 parallel groups, phase 3 study to compare the efficay and safety of masitinib to sunitinib in patients with gastrointestinal stromal tumor after progression with imitinib - AB11002
AB Science0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. patient with histological proven metastatic GIST (gastro-intestinal stromal cancer) or non-operable locally advanced GIST;
- •2. patient with measurable tumor lesions with longest diameter >=20 mm using conventional techniques or >= 10 mm with spiral CT scan according to Recist 1.1;
- •3. patient with C-kit (CD117) positive tuimour detected immunohistochemically;
- •4. patient after progression with imatinib up to 800mg;
- •5. patient with ECOG <=2;
- •6.Patient with adequate organ functions;
- •7. patient with life expectancy >3 months;
- •8. male or female >18 years;
- •9. patient with a BMI > 18 kg/m2 and weightening at least 40 kg;
排除标准
- •1. patient treated for a cancer other vthan GIST within 5 years before enrolmentwith the exception of basal cell carcinoma or cervical cancer in situ;
- •2. patient with active CNS metastasis or with history of CNS mtastasis;
- •3. patient with certain cardiac disorder;
- •4.patient with history of poor compliance or history of drug/alcohol abuse or excessive alcohol beverage consumption;
- •5. pregnant or nursing female
研究者
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