KCT0002997已完成未知
The Pilot Study to Evaluate the Safety and Efficacy of Sirolimus, in Subject With Refractory Solid Tumors
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 25
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
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Patients with the will and ability to sign a clinical trial agreement voluntarily and complete all requirements for a clinical trial
- •3. Any type of non-resistant type that shows an organized PI CA CA mutation or PI K CA amplification (H1N1 R, E154K, E145K, PTEN LOSS)
- •4. ECOG Activity also 0-2
- •5. If at least one measurable or non-measurable lesion is present on the RECIST version 1.1 standard (this lesion must be evaluated at least 28 days before administration begins)
- •6. Patients with appropriate organ function defined by the following criteria
- •- Blood test : ANC = 1.5 x 109 / L, Hemoglobin = 9 hemogeullobinL, Platelet = 75 x 109 / L
- •- Liver function : bilirubin = 1.5 x UNL, AST / ALT = 2.5 x UNL (if there is an electric charge)
- •- New : serum creatinine = 1.5 x UNL
- •7. Use appropriate contraception for men and women during childbearing.
- •8. Appropriate heart function without clinically significant changes that do not require normal or medical intervention, with no more than a 12-lead ECG and other history of history than the Symptom NM
排除标准
- •1. If a patient is diagnosed with another type of malignant tumor (other than non-resistant solid cancer) (other than a properly treated baseline or squamous cell skin cancer),
- •2. Has a history of hydrostatic or brain transfer (if the condition is previously treated properly and is currently not given steroids for anticonvulsia or brain pressure control)
- •3. Patients with clinically significant gastrointestinal disorders that may cause a disturbance in the ingestion, distribution or absorption of test drugs, such as in the absence of oral administration of purified water.
- •4. If you have the following cardiovascular conditions within the last six months (cardiovascular surgery or state-through, myocardial infarction, unstable angina, coronary artery bypass surgery, and peripheral cardiovascular disease),
- •5. Uncoordinated convulsions, central nervous system disease or psychiatric illness combined, making it difficult for researchers to voluntarily agree to a clinical trial
- •6. . Women who are feeding shall stop breastfeeding before the first dose of the test medication and shall not breast-feed for 14 days after the last dose of the test medication.
- •7. Patients with Active Infections or other uncontrolled disease
- •8. In case of a previously administered sirolimus
研究者
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