Metformin as maintenance therapy in bone sarcomas at high risk of relapse - Metformina-Bone

Istituto Ortopedico Rizzoli0 个研究点目标入组 67 人开始时间: 2024年6月24日最近更新: 2024年8月21日

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•Age = 10 years, Body weight = 30 kg, Patients with localized Osteosarcoma with necrosis = 60% at the end of postoperative chemotherapy (within 45 days of completion), Patients with osteosarcoma or Ewing's sarcoma rendered disease-free after first relapse (within 45 gg of surgery or chemotherapy termination), Patients not included in other protocols, Patients able to swallow, Screening within 30 days of chemotherapy termination (or relapse surgery), Starting treatment within 30 from screening, Normal renal function (creatinine <1.3 mg/L, creatinine clearance =70 mL/min) and liver function (serum total bilirubin <1.2 mg/dL, except patients with Gilbert syndrome), AST and ALT <1.8 times the value above the normal range

•Type I or II diabetes, Patient with metastatic disease, Patients with hypersensitivity to the active ingredient or any of the excipients Patients with any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis), Patients with renal insufficiency (GFR < 70 ml/min)., Patients with acute conditions potentially affecting renal function such as dehydration, severe infection, shock, Patients with liver failure, acute alcohol intoxication, alcoholism., Patients with conditions that can cause tissue hypoxia: decompensated heart failure, respiratory failure, recent myocardial infarction, shock., Patient who does not fit the inclusion criteria, Pregnant or lactating women or women of childbearing age who cannot rule out pregnancy status (possibly ruled out by serological pregnancy test (hCG research)), according to CTFG recommendations.

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