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New treatment option for Osteosarcoma
Official title Metformin as Maintenance Therapy in Patients With Bone Sarcoma and High Risk of Relapse
ClinicalTrials.gov ID: NCT04758000
What this study is testing
What is Metformin Hydrochloride?
Metformin Hydrochloride is an investigational medicine, being studied as a potential treatment for osteosarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Primitive bone sarcoma are rare tumors with low options of therapy for patient treatment. 1.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 and older
You may be able to join if
- Non metastatic osteosarcoma patients with necrosis ≤ 60 % in the end of post-operatory chemotherapy treatment (within 45 days.from the end of...
- Osteosarcoma or Ewing sarcoma patients free from the disease after first relapse (within 45 days.from the local surgery or 45 days from the end of...
- ≥ 14 years.
- Patient should not be participating in other clinical study.
- Patients should be able to swallow.
You likely can't join if
- Type B diabetic patient
- Metastatic patients
- Patients with acute metabolic acidosis (lactic acidosis, diabetic ketoacidosis).
- Patients with renal insufficiency (GFR \< 70 ml/min).
- Patients with acute conditions that could cause kidney alterations as dehydration, severe infection and shock.
- Patients with hepatic insufficiency as acute alcohol intoxication and alcoholism.
See the full eligibility criteria
- Non metastatic osteosarcoma patients with necrosis ≤ 60 % in the end of post-operatory chemotherapy treatment (within 45 days.from the end of chemotherapy treatment).
- Osteosarcoma or Ewing sarcoma patients free from the disease after first relapse (within 45 days.from the local surgery or 45 days from the end of chemotherapy treatment).
- ≥ 14 years.
- Patient should not be participating in other clinical study.
- Patients should be able to swallow.
- Screening up to 30 days from the end of chemotherapy treatment or relapse.
- Start therapy up to 30 days from the screening.
- Normal renal function (creatinine \<1,3 mg/L, clearance creatinine ≥ 70 ml/min) end liver function (total serum bilirubina \<1,2 mg/dL, except Gilbert syndrome patients), AST e ALT \<1,8 times the normal range value
- Type B diabetic patient
- Metastatic patients
- Patients with acute metabolic acidosis (lactic acidosis, diabetic ketoacidosis).
- Patients with renal insufficiency (GFR \< 70 ml/min).
- Patients with acute conditions that could cause kidney alterations as dehydration, severe infection and shock.
- Patients with hepatic insufficiency as acute alcohol intoxication and alcoholism.
- Patients with medical conditions that could cause tissue hypoxia: decompensated heart failure, respiratory failure, recent myocardial infarction, shock.
- Patient who does not meet the inclusion criteria
- Pregnant and breastfeeding patients, or young women at childbearing age who cannot exclude the state of pregnancy (possibly excluded by serum pregnancy test (BhCG test), in accordance with the recommendations of the...
The study team makes the final eligibility decision.
Where it's taking place
- Bologna, Italy
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bologna, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.