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

Phase 1

Conditions: bone sarcoma
MedDRA version: 20.0Level: HLTClassification code: 10039498Term: Bone sarcomas Class: 10029104
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: CTIS2024-515639-32-00

Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 67

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate EFS (Event Free Survival) in patients with osteosarcoma and Ewing's sarcoma at high risk of relapse compared with that found in historical controls.;Secondary Objective: Evaluate metformin toxicity (blood tests, clinical assessment), therapy compliance with age-adjusted EORTC QLQ-C30 questionnaire for adults.;Primary end point(s): Event Free Survival

Secondary Outcome Measures