Phase I study of Everolimus combined with Metformin for patients with advanced cancer - Everolimus and Metformin for advanced cancer

Academisch Medisch Centrum0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•- Signed informed content obtained prior to treatment
•- Cytological or histological confirmed malignancies
•- ECOG/ WHO performance 0-2
•- Age > 18 years
•- Life expectancy of at least 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, * 3 × ULN for patients known to have Gilbert Syndrome, 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).
•- Fasting serum cholesterol * 7.75 mmol/L and fasting triglycerides * 2.5 × ULN. In case one or both of these thresholds are exceeded, the patient can only be included after initiation of statin therapy or other lipid lowering drugs (eg fibrates), and when the above mentioned values have been achieved.
•- Adequate bone marrow function ((Absolute neutrophil count (ANC * 1.5 109/L ,platelets > 100 x 10 9/L)
•- Mentally, physically, and geographically able to undergo treatment and follow up

•- 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, active or uncontrolled severe infection, cirrhosis, chronic active hepatitis or chronic persistent hepatitis (see screening for hepatitis Appendix A), severely impaired lung function
•- Uncontrolled diabetes as defined by fasting serum glucose >2X ULN.
•- Patients with a known hypersensitivity to metformin
•- Use of metformin in the previous 6 months
•- Patients that have received everolimus in the past
•- Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin)
•-Concomitant use of strong CYP3A4, 3A5 and 2C8 inhibitors or inducers (see section 2.1.12

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