NCT01506336已完成2 期
A Prospective, Multicenter, Randomized, Open-label, Active Controlled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of Masitinib at 12 mg/kg/Day to Sunitinib at 50 mg/Day in Treatment of Patients With Gastro-intestinal Stromal Tumor Resistant to Imatinib
AB Science1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2008年10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
- 44
- 试验地点
- 1
- 主要终点
- overall progression free survival
研究概览
简要总结
The objective is to compare efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in treatment of patients with gastro-intestinal stromal tumor resistant to imatinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histological proven, metastatic, or locally advanced and non-operable GIST
- •Measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan according RECIST criteria
- •C-kit (CD117) positive tumors detected immuno-histochemically and documented mutation of c-kit at any time if available
- •Patients resistant to imatinib at dose of 400 mg/day
排除标准
- •Patient treated for a cancer other than GIST cancer within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ
- •Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
研究组 & 干预措施
masitinib
Experimental
masitinib 12 mg/kg/day
干预措施: masitinib (Drug)
sunitinib
Active Comparator
sunitinib 50 mg/day
干预措施: sunitinib (Drug)
结局指标
主要结局
overall progression free survival
时间窗: up to 36 weeks
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 weeks
次要结局
- overall survival(up to 36 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With ImatinibGastrointestinal Stromal TumorsNCT01694277AB Science258
已完成
3 期
Masitinib in Treatment of Patients With Severe Persistent Asthma Treated With Oral CorticosteroidsAsthmaNCT01449162AB Science420
终止
3 期
Masitinib in Patients With Localized, Primary GIST After Complete Surgery and With High Risk of RecurrenceGastro-Intestinal Stromal TumourNCT02009423AB Science7
终止
3 期
Masitinib in Non-Resectable or Metastatic Stage 3/4 Melanoma Carrying a Mutation in the Juxta Membrane Domain of c-KitMetastatic MelanomaNCT01280565AB Science134
终止
3 期
A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Patients With Relapse or Refractory Multiple MyelomaMultiple MyelomaNCT01470131AB Science147