NCT02450149已完成不适用
Single-arm Study to Evaluate the Safety and Efficacy of Sorafenib, in Subjects With BRAF Mutation Refractory Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
This is a pilot study of sorafenib in patients with BRAF Mutation Refractory Solid Tumors.
This study is a single-arm, pilot study of sorafenib in patients with Refractory Solid Tumors harboring BRAF Mutation Sorafenib 400 mg will be administered orally twice a day for 28 days.
To investigate the efficacy of sorafenib in patients with Refractory Solid Tumors harboring BRAF Mutation.
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
- •Provision of fully informed consent prior to any study specific procedures.
- •Patients must be ≥20 years of age.
- •BRAF mutation Refractory Solid Tumors that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.
- •ECOG performance status 0-
- •Have measurable or evaluated disease based on RECIST1.
- •as determined by investigator.
- •Adequate Organ Function Laboratory Values
- •Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 100 x 109/L
- •bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
- •creatinine ≤1.5 x UNL
- •Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
- •Adequate heart function.
排除标准
- •Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤3 years.
- •Has known active central nervous system (CNS) metastases.
- •Has an active infection requiring systemic therapy.
- •Pregnancy or breast feeding
- •Patients with cardiac problem.
- •Any previous treatment with sorafenib
研究组 & 干预措施
Sorafenib
Experimental
Sorafenib 400 mg will be administered orally twice a day for 28 days.
干预措施: sorafenib (Drug)
结局指标
主要结局
progression-free survival
时间窗: expected average of 24 weeks
次要结局
- objective response rate(expected average of 24 weeks)
- Time to progression(expected average of 24 weeks)
- overall survival(expected average of 24 weeks)
- Number of subjects with Adverse Events as a measure of toxicity profile(expected average of 24 weeks)
研究者
Seung tae Kim
MD,PhD
Samsung Medical Center
研究点 (1)
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