2024-520228-28-00招募中2 期
Phase 2, open-label, single-arm study on the use of metformin as adjunctive therapy in high-grade glioma
Universita Degli Studi Di Milano Bicocca1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年2月10日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- PFS assessed at V3 (at approximately 6 months after treatment initiation). Progression is defined as recurrence from documentable disease on MRI by assessment with RANO (Response Assessment in Neurooncology) criteria (MRI T1w-Gd; T2 Flair)
研究概览
简要总结
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)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
PFS assessed at V3 (at approximately 6 months after treatment initiation). Progression is defined as recurrence from documentable disease on MRI by assessment with RANO (Response Assessment in Neurooncology) criteria (MRI T1w-Gd; T2 Flair)
PFS assessed at V3 (at approximately 6 months after treatment initiation). Progression is defined as recurrence from documentable disease on MRI by assessment with RANO (Response Assessment in Neurooncology) criteria (MRI T1w-Gd; T2 Flair)
次要结局
- Health-related quality of life measured by EORTC QLQ-C30 and MMSE questionnaires assessed at V0 and V3. The data obtained will be compared with population data
- Safety will be assessed throughout the study as type, frequency and severity of grade III and IV events. Tolerability will be assessed as number of discontinuations or dose reduction and by evaluation of clinical and hematochemical parameters (blood count, liver and kidney toxicity, blood glucose) assessed during the study.
- Plasma measurement of circulating metabolites, adiponectin and proteomic analysis as potential prognostic and response markers. Overall assessment of this endpoint will be performed at the end of the study.
- In vitro response of cells taken from patients' tissue samples during surgery to treatment with TMZ or TMZ plus MET or vehicle measured as cell growth inhibition and correlation with clinical response (PFS) of the same patient. - Transcriptomic analysis to identify the molecular phenotype of cells taken from patients' tissue samples during surgery and comparison between clinical response and molecular phenotype. Evaluation of these endpoints will be performed at the end of recruitment.
研究者
Rosa Moresco
Scientific
Universita Degli Studi Di Milano Bicocca
研究点 (1)
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