NL-OMON34831已完成2 期
A phase II, randomized, placebo controlled study to evaluate the efficacy of the combination of gemcitabine, erlotinib and metformin in patients with locally advanced and metastastatic pancreatic cancer - metformin and pancreatic cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-Cytological or histological confirmed carcinoma of the pancreas
- •-Measurable lesion according to RECIST criteria
- •-ECOG/ WHO performance 0-2
- •-Age > 18 years
- •-Life expectancy > 3 months
- •-Adequate renal function (creatinine < 150 µmol/L and/ or a creatinine clearance > 60 ml/ L)
- •-Adequate liver function (bilirubin < 1.5 times upper limit of normal, ALAT or ASAT < 5.0 times upper limit of normal in case of liver metastases and < 2.5 the upper limit of normal in absence of liver metastases).
- •-Adequate bone marrow function (WBC > 3.0 x 10 9/L, platelets > 100 x 10 9/L)
- •-Mentally, physically, and geographically able to undergo treatment and follow up
排除标准
- •-Clinical or radiological evidence of CNS metastases
- •-Pregnancy (positive serum pregnancy test) and lactation
- •-Serious concomitant systemic disorder that would compromise the safety of the patient, at the discretion of the investigator
- •-Patients who have any severe and/or uncontrolled medical conditions such as:
- •* unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction
- •* 6 months prior to randomization, serious uncontrolled cardiac arrhythmia,
- •* uncontrolled diabetes as defined by fasting serum glucose >2X ULN.
- •* active or uncontrolled severe infection.
- •* cirrhosis, chronic active hepatitis or chronic persistent hepatitis
- •* severely impaired lung function
- •-Previous treatment with erlotinib and/ or gemcitabine
- •-Patients with a known hypersensitivity to metformin
- •-Use of metformin in the previous 6 months
研究者
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