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Neoplasms
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Neoplasms
- 发起方
- Samsung Medical Center
- 入组人数
- 25
- 状态
- 已完成
- 最后更新
- 3年前
概览
简要总结
暂无简介。
研究者
入排标准
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
结局指标
主要结局
未指定
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