KCT0003729进行中（未招募）未知
A phase II, open-label, study in patients with refractory, metastatic cancer harboring KIT mutation or amplification to investigate the clinical efficacy and safety of imatinib therapy
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1.age = 20
- •2.advanced, refractory cancer patients who failed standard of care (SOC)
- •3.KIT aberration: defined as mutation in exons 9, 11, 13, 17 or 18, or nanostring CNV by quantitative PCR (greater than 3 copies) or subject with specific sensitivity (Z-score<-0.5) to imatinib by Avatar scan whose disease has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy
- •4.ECOG performance status of 0~2
- •5.measurable or evaluable lesion per RECIST 1.1 criteria
- •6.adequate marrow, hepatic, renal and cardiac functions
- •?Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) = 2.5 x upper limit of normal (ULN), or AST and ALT = 5 x ULN if liver function abnormalities are due to underlying malignancy
- •?Total serum bilirubin = 1.5 x ULN
- •?Absolute neutrophil count(ANC) = 1,500/uL
- •?Platelets = 100,0000/uL
- •?Hemoglobin = 9.0 g/dL
- •7.provision of a signed written informed consent
排除标准
- •1.severe co-morbid illness and/or active infections
- •2.pregnant or lactating women
- •3.history of major surgery or radiotherapy within 4 weeks
- •4.active CNS metastases not controllable with radiotherapy or corticosteroids
- •(however, CNS metastases (except for leptomeningeal seeding) are allowed if controlled by gamma knife surgery or surgery or radiotherapy or steroid)
- •5.known history of hypersensitivity to study drugs
研究者
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