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Status:

UNKNOWN

Activity and Safety of Everolimus+Octreotide LAR+Metformin in Advanced Pancreatic Well-differentiated NETs

Lead Sponsor:

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Conditions:

Well Differentiated Pancreatic Endocrine Tumor

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

Abnormal PI3K-Akt-mTOR (mammalian target of rapamycin) pathway signaling and autocrine activation of the mTOR pathway, mediated through insulin-like growth factor 1 (IGF1), has been implicated in the ...

Detailed Description

Abnormal PI3K-Akt-mTOR (mammalian target of rapamycin) pathway signaling and autocrine activation of the mTOR pathway, mediated through insulin-like growth factor 1 (IGF1), has been implicated in the ...

Eligibility Criteria

Inclusion

  • Signature of written informed consent (approved by the Institutional Ethics Committee Independent ) obtained after a careful study of screening procedures
  • Age \>= 18 years old.
  • Patients with histological evidence of pNET well-differentiated G1 -G2
  • Configurable tumor disease (according to RECIST (Response Evaluation Criteria In Solid Tumors) ) .
  • Karnofsky Performance Status \>= 60%.
  • Life expectancy greater than 6 months.
  • Is permitted to enroll patients who have not received any treatment for advanced disease or patients pretreated with surgery , chemotherapy or somatostatin analogues .
  • 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( aspartate aminotransferase), ALT (alanine aminotransferase)\<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 ( Creatinine Clearance rate) ≥ 60 mL / min 9 . During the study of male and female patients must use adequate contraceptive methods .

Exclusion

  • Patients with histological evidence of malignant insulinoma ( pNET )
  • Surgeries performed within 28 days prior to the start of treatment.
  • 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.
  • 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.
  • 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.
  • Active or uncontrolled severe infections .
  • Cirrhosis , acute hepatitis or chronic active hepatitis .
  • Poor control of diabetes HbA1c \> = 8.0 % .
  • 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.
  • Using anti - IL6 (Interleukin 6) or IGF1 .
  • Uncontrolled high blood pressure , atrial fibrillation .
  • History of immunosuppression included positive HIV test .
  • No previous or concomitant oncological pathology , except: basal cell skin cancer, in situ , as long as every other cancer patient diseasefree for at least 5 years.
  • They excluded patients with a condition of metabolic acidosis , acute or chronic , including ketoacidosis .
  • History of alcohol abuse , or habitual intake of alcohol (≥ 3 glasses of alcoholic drinks / day) sufficient to cause hepatotoxicity.
  • Prolonged fasting .
  • Severe states of dehydration.

Key Trial Info

Start Date :

June 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2021

Estimated Enrollment :

26 Patients enrolled

Trial Details

Trial ID

NCT02294006

Start Date

June 1 2014

End Date

October 1 2021

Last Update

September 9 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Fondazione IRCCS Istituto Tumori Milano

Milan, Italy, 20133