advanced/ or not resectable well differnciated pancreatic neuroendocrin tumor MedDRA version: 16.1 Level: LLT Classification code 10067518 Term: Pancreatic neuroendocrine tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.1 Level: PT Classification code 10068909 Term: Pancreatic neuroendocrine tumour metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Afinitor
Product Name: Afinitor
Product Code: 039398045
Pharmaceutical Form: Tablet
INN or Proposed INN: Afinitor
CAS Number: 159351-69-6
Other descriptive name: EVEROLIMUS
Trade Name: Sa
Sponsors
Fondazione IRCCS Istituto Nazionale dei tumori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate progression free survival;Secondary Objective: safety, overall survival, response rate;Primary end point(s): safety, overall survival, response rate;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): to evaluate circulant biomarkers levels (IL 6, IGF1);Timepoint(s) of evaluation of this end point: 1 year | — |
Countries
Italy
Contacts
Public ContactTrials center
Fondazione IRCCS Istituto Nazionale dei tumori
Outcome results
None listed