Administration of Metformin as maintenance therapy in patients with osteosarcoma or Ewing's sarcoma

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002579-37-IT

Enrollment

Registered

2020-10-22

Start date

2020-11-18

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteosarcoma and Ewing's Sarcoma MedDRA version: 20.0 Level: PT Classification code 10023676 Term: Lactic acidosis System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 20.1 Level: LLT Classification code 10000491 Term: Acidosis lactic System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: ZUGLIMET - 500 MG COMPRESSE RIVESTITE CON FILM 30 COMPRESSE IN BLISTER PVC/AL Product Name: Zuglimet cpr riv 500 mg Product Code: [038257022] Pharmaceutical Form: Coated tablet INN or Prop

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age = 14 years - Patients with localized osteosarcoma with necrosis = 60% at the end of postoperative chemotherapy (within 45 days) - Patients with osteosarcoma or Ewing's Sarcoma made disease-free after the first relapse (within 45 days of surgery or chemotherapy) - Patients not included in other protocols - Patients who can swallow - Screening within 30 days after the end of chemotherapy (or relapse surgery). - Start of treatment within 30 minutes after screening - Normal renal function (creatinine 60) and liver function (serum bilirubin =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Type I or II diabetes - Patient with metastatic disease - Patients with kidney failure of any degree - Patient who does not meet the inclusion criteria

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of EFS (Event Free Survival) in patients with osteosarcoma and Ewing's Sarcoma at high risk of relapse compared to that found in historical controls.;Secondary Objective: Evaluate metformin toxicity (blood tests, clinical evaluation), compliance of therapy with EORTC QLQ C-30 questionnaire for adults based on age.;Primary end point(s): - In cohort 1 (localized osteosarcomas with poor necrosis) increase EFS to 3 years from 35% (personal case references) to 60%. - In cohort 2 (patients made disease-free after relapse both osteosarcomas and Ewing's sarcomas) increase Post Relapse Disease Free Survival (PRDFS) to 1 year after achieving complete post- relapse remission from 20% (historical references) to 45%.;Timepoint(s) of evaluation of this end point: 3 years	—

Measure

Time frame

Main Objective: Evaluation of EFS (Event Free Survival) in patients with osteosarcoma and Ewing's Sarcoma at high risk of relapse compared to that found in historical controls.;Secondary Objective: Evaluate metformin toxicity (blood tests, clinical evaluation), compliance of therapy with EORTC QLQ C-30 questionnaire for adults based on age.;Primary end point(s): - In cohort 1 (localized osteosarcomas with poor necrosis) increase EFS to 3 years from 35% (personal case references) to 60%. - In cohort 2 (patients made disease-free after relapse both osteosarcomas and Ewing's sarcomas) increase Post Relapse Disease Free Survival (PRDFS) to 1 year after achieving complete post- relapse remission from 20% (historical references) to 45%.;Timepoint(s) of evaluation of this end point: 3 years

—

Countries

Italy

Contacts

Public ContactSSD Chemioterapia dei tumori dell'a

IRCCS Istituto Ortopedico Rizzoli

alessandra.longhi@ior.it0516366277

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026