NCT02449538已完成2 期
Study to Evaluate the Safety and Efficacy of Everolimus, in Subjects With PIK3CA Amplification, PTEN Loss and PIK3CA Mutation Refractory Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- overall response rate
研究概览
简要总结
This study is a single-arm, phase II study of everolimus in patients with PTEN loss ,PIK3CA mutation and PIK3CA amplification Refractory Solid Tumors .
Everolimus 10 mg will be administered orally qd daily.
To investigate the efficacy and safety of everolimus in patients with PTEN loss ,PIK3CA mutantion and PIK3CA amplification 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, PTEN loss and PIK3CA 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 ≥ 75 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.
- •KRAS mutation (codon 12 or 13) or BRAF mutation (V600)
- •Any previous treatment with everolimus
研究组 & 干预措施
everolimus
Experimental
everolimus 10 mg qd daily
干预措施: everolimus (Drug)
结局指标
主要结局
overall response rate
时间窗: 24 weeks
次要结局
- progression free survival(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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