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Clinical trial on the use of metformin in addition to standard therapy in patients with high-grade glioma
EU CTIS ID: 2024-520228-28-00
What this study is testing
Determine efficacy at the recommended dose of metformin in patients with glioblastoma. Efficacy will be assessed by PFS at 6 months after initiation of treatment. Radiographic response will be assessed by RANO (Response Assessment in Neurooncology) criteria compared with the patient's condition at baseline (MRI performed postsurgery)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - Patients with newly diagnosed histologically confirmed GBM (WHO grade IV, IDH wild type) undergoing surgical resection;
- - Hypomethylation or hypermethylation of MGMT evaluated post-surgery;
- - Adult patients (=18 years), both sexes;
- - Patients undergoing Stupp protocol including patients aged >70 years performing hypofractionated protocol and three weeks of chemotherapy;
- - Karnofsky Performance Status (KPS) > 60 assessed post-surgery;
- - Life expectancy at least 6 months defined by tumor lesion size and location;
You likely can't join if
- - Multicenter GBMs;
- - Patients diagnosed with diabetes or diabetes-related conditions;
- - Other active malignancies;
- - Hypersensitivity, intolerance to metformin or excipients;
- - Impaired renal function with creatinine clearance < 60 mL/min assessed at recruitment; liver failure assessed at recruitment by clinical history and examination of ALT, AST and total bilirubin; and other contraindications to metformin use;
- - Taking metformin, insulin or other biguanides, regardless of the reason;
See the full eligibility criteria
- - Patients with newly diagnosed histologically confirmed GBM (WHO grade IV, IDH wild type) undergoing surgical resection;
- - Hypomethylation or hypermethylation of MGMT evaluated post-surgery;
- - Adult patients (=18 years), both sexes;
- - Patients undergoing Stupp protocol including patients aged >70 years performing hypofractionated protocol and three weeks of chemotherapy;
- - Karnofsky Performance Status (KPS) > 60 assessed post-surgery;
- - Life expectancy at least 6 months defined by tumor lesion size and location;
- - Freely given written informed consent prior to any study-related activity. Patients must be able to communicate with the investigator and comply with study procedures;
- - Women of childbearing age must test negative for pregnancy at enrollment and, if they have sex, must agree to use specific contraceptive methods. Female subjects of childbearing age, i.e., fertile, after menarche and until post-menopause unless permanently infertile, who are sexually active, must apply a highly effective method of birth control with a low failure rate (i.e., less than 1 percent per year), such as combined hormonal contraception (containing estrogen and progestin) combined with ovulation inhibition (oral intravaginal, or transdermal), progestin-only hormonal contraception associated with ovulation inhibition (oral, injectable, or implantable), intrauterine device (IUD), intrauterine hormone delivery system (IUS), bilateral tubal occlusion, vasectomized partner, or sexual abstinence, throughout the treatment period and for four weeks after the last dose of the study treatment. Hormonal methods other than levonorgestrel-containing devices or medroxyprogesterone injections should be supplemented with the use of a male condom. Women of nonfertile age may be included if surgically sterile or postmenopausal for at least 2 years. The investigator is responsible for determining whether the patient has adopted an appropriate method of contraception for participation in the study.
- - Male subjects with female partners of childbearing age must use condoms during treatment and until the end of relevant systemic exposure.
- - Multicenter GBMs;
- - Patients diagnosed with diabetes or diabetes-related conditions;
- - Other active malignancies;
- - Hypersensitivity, intolerance to metformin or excipients;
- - Impaired renal function with creatinine clearance < 60 mL/min assessed at recruitment; liver failure assessed at recruitment by clinical history and examination of ALT, AST and total bilirubin; and other contraindications to metformin use;
- - Taking metformin, insulin or other biguanides, regardless of the reason;
- - Pregnancy or lactation;
- - The patient has serious pre-existing medical conditions that, in the opinion of the investigator, would preclude participation in this study.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.