for which no standard treatment is available/ various types of cancer for which no standard treatment is available various malignancies
Conditions
Interventions
Treatment with everolimus orally once daily and metformin orally BID. Both will
be taken contninuously.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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 60 ml/ L) - Adequate liver function (bilirubin 100 x 10 9/L) - Mentally, physically, and geographically able to undergo treatment and follow up
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: assessment of the dose limiting toxicity (DLT) and the maximal tolerated dose (MTD) of the combination of everolimus and metformin. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: - Efficacy: response rate in patients with measurable disease - Safety: treatment toxicity - Exploratory endpoint: iInvestigation of potential biomarker development based on assessment of skin biopsies and blood samples | — |
Countries
Netherlands
Outcome results
None listed