NCT02449564已完成不适用
The Pilot Study Evaluate the Safety and Efficacy of Sirolimus in Patients With PIK3CA Mutation and/or PIK3CA Amplification 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
- 5
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
This study is a single-arm, phase II study of sirolimus in patient with PIK3CA mutation and PIK3CA amplication Refractory solid tumors.
sirolimus 1mg will be administered orally qd daily.
To investigate the efficacy of sirolimus in patients with PIK3CA mutation and PIK3CA amplication Refractory solid tumors.
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.
- •PIK3CA amplification and/or PIK3CA mutation Refractory Solid Tumors.
- •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 ≤5 years.
- •Has known active central nervous system (CNS) metastases.
- •Has an active infection requiring systemic therapy.
- •Pregnancy or breast feeding
- •Patients with cardiac problem.
研究组 & 干预措施
sirolimus
Experimental
sirolimus 1mg daily
干预措施: sirolimus (Drug)
结局指标
主要结局
progression-free survival
时间窗: 24 weeks
次要结局
- overall response rate(24 weeks)
- Time to progressive(24 weeks)
- overall survival(24 weeks)
- Number of subjects with Adverse Events as a measure of toxicity profile(24 weeks)
研究者
Jeeyun Lee
MD,PhD
Samsung Medical Center
研究点 (1)
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