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

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: advanced/ or not resectable well differnciated pancreatic neuroendocrin tumor
Sponsor: Fondazione IRCCS Istituto Nazionale dei tumori
Enrollment: 43
Status: Active, not recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

March 10, 2014

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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.

•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 .