The Pilot Study to Evaluate the Safety and Efficacy of Sirolimus, in Subject With Refractory Solid Tumors

Samsung Medical Center0 个研究点目标入组 25 人开始时间: 待定最近更新: 2022年11月28日

适应症

试验速览

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•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

•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

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