NCT00421317终止2 期
A Phase II Multicentric Trial to Assess Efficacy and Toxicity of Imatinib in Adult Patients With Metastatic Ocular Melanoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 12
- 主要终点
- Progression-free rate at 3 months
研究概览
简要总结
The scope of the trial is to determinate the anti-tumoral activity of imatinib in metastatic ocular melanoma patients.
详细描述
Further study details as provided by Centre Oscar Lambret
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
- •Metastatic ocular melanoma
- •Age > or = 18 years old
- •Measurable metastases > or = 10 mm according to RECIST criteria
- •PS-WHO < or = 1 or IK > 70 percent
- •Normal hepatic function
- •PNN > 1500/mm3, platelets > or = 100 000/mm3
- •Contraception
- •Informed consent signed
排除标准
- •Patient with two prior lines of systemic treatment (chemotherapy, immunotherapy or association)
- •Other evolutive neoplasic disease
- •Severe hepatic insufficiency
- •Severe renal insufficiency
- •Somatic or psychiatric co-morbidity incompatible with the protocol
- •Leptomeningeal or cerebral metastatic dissemination
- •Pregnant or lactating woman
- •Other antitumoral treatment
- •Patient participating to another clinical trial with an experimental drug
- •Known hypersensitivity to Imatinib or one of its excipients
- •Resecable single metastasis
结局指标
主要结局
Progression-free rate at 3 months
次要结局
- Progression-free rate at 6 and 12 months
- Response rate according to RECIST criteria
- Toxicity
- Global survival,Progression-free survival
- Predictive genomic factors of response
研究者
研究点 (12)
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