EUCTR2014-000888-41-IT招募中1 期
Activity and safety of Everolimus in combination with octreotide LAR and Metformin in patients with advanced pancreatic well-differentiated Neuroendocrine Tumors (pWDNETs): a Phase II, open, monocentric, prospective study. - MetNET1 trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 43
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
- 性别
- All
入选标准
- •Signature of written informed consent (approved by the Institutional Ethics Committee Independent ) obtained after a careful study of screening procedures .
- •2 . Age >= 18 years old.
- •3 . Patients with histological evidence of pNET well-differentiated G1 -G2 .
- •4 . Configurable tumor disease (according to RECIST ) .
- •5 . Karnofsky Performance Status >= 60%.
- •6 . Life expectancy greater than 6 months.
- •7 . Is permitted to enroll patients who have not received any treatment for advanced disease or patients pretreated with surgery , chemotherapy or somatostatin analogues .
- •8 . Basal blood tests :
- •- Counts of neutrophils in absolute value > 1.5 x 109 / L.
- •- Platelet count > 100 x 109 / L.
- •- Hemoglobin > 9 g / dl .
- •- Total Bilirubin < 1.5 times the upper limit of normal .
- •- AST, ALT <2.5 times the upper limit of normal in patients without evidence of liver metastases.
- •- AST, ALT <2.5 times the upper limit of normal in patients with evidence of liver metastases.
- •- Alkaline phosphatase <2.5 times the upper limit of normal in patients with evidence of hepatic metastases
- •- Values ??of serum creatinine < 1.5 mg / dl. - CCr = 60 mL / min
- •9 . During the study of male and female patients must use adequate contraceptive methods .
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 34
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •1 . Patients with histological evidence of malignant insulinoma ( pNET )
- •2 . Surgeries performed within 28 days prior to the start of treatment.
- •3 . Evidence of metastasis at the level of the central nervous system or spinal cord compression . Patients should be subjected to a recent study MRI or CT scan at least 28 days from the date of randomization.
- •4 . Clinically significant cardiovascular disease , such as cardiovascular accidents occurred in less than 6 months, unstable angina , congestive heart failure grade greater than or equal to II ( according to the classification of the New York Heart Association NYHA ) series cardiac arrhythmias that require treatment.
- •5 . Important comorbidities , metabolic disorders , clinical examination or laboratory investigations , which contraindicate the use of drugs to study, or patients at high risk of complications from the treatment.
- •6 . Active or uncontrolled severe infections .
- •7 . Cirrhosis , acute hepatitis or chronic active hepatitis .
- •8 . Poor control of diabetes HbA1c > = 8.0 % .
- •9 . Diabetic patients who are treated with metformin are eligible if they have enabled the treatment with metformin for less than 6 months. Are excluded diabetic patients who make use of other hypoglycemic agents such as sulfonylureas, insulin , glinides as monotherapy or in combination with metformin.
- •10 . Using anti - IL6 or IGF1 .
- •11 . Uncontrolled high blood pressure , atrial fibrillation .
- •12 . History of immunosuppression included positive HIV test .
- •13 . No previous or concomitant oncological pathology , except: basal cell skin cancer, in situ , as long as every other cancer patient disease-free for at least 5 years.
- •14 . They excluded patients with a condition of metabolic acidosis , acute or chronic , including ketoacitosi .
- •15 . History of alcohol abuse , or habitual intake of alcohol (= 3 glasses of alcoholic drinks / day) sufficient to cause hepatotoxicity.
- •16 . Prolonged fasting .
- •17 . Severe states of dehydration.
研究者
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