A PHASE II PILOT STUDY OF METFORMIN TREATMENT IN PATIENTS WITH WELL-DIFFERENTIATED NEUROENDOCRINE TUMORS
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
Neuroendocrine tumors are rare but recent data showed a relevant increase in its incidence. The Mammalian Target of Rapamycin (mTOR), one of most important area of research, has demonstrated be a therapeutic target in these tumors. The metformin has demonstrate in preclinical studies having an antineoplastic action by inhibiting the mTOR pathway, and may be an alternative treatment for this disease.
Eligible patients for this study should have metastatic gastroenteropancreatic neuroendocrine tumors well differentiated (grade 1 or grade 2) and will be treated with metformin 850 mg every 12 hours, and each cycle will consist of 30 days. After 180 days of treatment the efficacy of metformin under the control of disease progression will be evaluated. As a secondary outcome the investigator will check the patient adherence to the treatment, the control of patient symptoms with functioning neuroendocrine tumor, and disease free survival. Also will be performed an analysis of immunohistochemical expression of mTOR pathway proteins of these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic well-differentiated neuroendocrine tumor grade 1 or 2 with histological confirmation;
- •Performance status according to Eastern Cooperative Oncology Group (ECOG) 0 to 2;
- •Able to take pills;
- •Age ≥ 16 years;
- •Ability to Provide Written Informed Consent;
- •Adequate organ function;
排除标准
- •Patient with out of control severe hormonal syndrome;
- •Diabetic patients under metformin treatment, or those who have received treatment with metformin within 3 months;
- •Patient with hypersensitivity to biguanides, kidney or liver failure, or other conditions that predispose to lactic acidosis;
- •History of severe clinical or psychiatric illness, that would prevent participation in the study by clinical judgment;
- •Patients who participate in other protocol with experimental drugs;
- •Patients under any kind of active infection;
- •Patients who have received chemotherapy within 3 weeks;
- •Patients pregnant or lactating;
- •Diabetic patients who require higher dose of metformin 850mg x 2 daily;
研究组 & 干预措施
METFORMIN
850mg of metformin every 12 hours.
干预措施: Metformin (Drug)
结局指标
主要结局
Disease free survival
时间窗: After 180 days of treatment.
次要结局
- Number of Participants with Adverse Events Related to Metformin Measured of Safety and Tolerability(Assessments will be performed until 180 days after treatment initiation)
- Clinical benefit(Assessments will be performed until 180 days after treatment initiation.)
- Biochemical response(Assessment will be performed at day 90 and 180 of treatment.)
- Evaluation of patient's glycemic profile(Assessment will be performed at day 90 and day 180 of treatment.)