Single-arm Study to Evaluate the Safety and Efficacy of Sunitinib, in Subjects With RET Fusion Positive or FGFR2 Amplification, Refractory Solid Tumors
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 sunitinib in patients with RET fusion positive or FGFR2 Amplification Refractory solid tumors.
This study is a single-arm, pilot study of sunitinib in subjects with Refractory solid tumors harboring RET fusion positive or FGFR2 Amplification sunitinib 50mg will be administered orally once a day 42 days.Study treatment will be continued until objective disease progression.
To investigate the efficacy of sunitinib in subjects with Refractory solid tumors harboring RET fusion positive or FGFR2 Amplification.
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.
- •RET fusion positive,FGFR amplification, 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.
- •Any previous treatment with sunitinib
研究组 & 干预措施
sunitinib
sunitinib 50mg will be administered orally once a day 42 days.Study treatment will be continued until objective disease progression.
干预措施: sunitinib (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
Joon Oh Park
MD,PhD
Samsung Medical Center