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A Biological Prospective Study in Patients With Metastatic Pancreatic NETs Treated With Everolimus

NCT02305810 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2018-11-07

No results posted yet for this study

Summary

Everolimus represents an approved therapy for patients with advanced well/moderately differentiated pancreatic NETs. Although some patients could benefit from this drug in terms of long-term tumor growth control, others are resistant upfront or become resistant during treatment. Therefore, it is crucial to detect some biological factors which can help to identify the responsive tumors. Given that Everolimus is a biological agent and its mechanism of action can be partially directed towards angiogenesis its effects can be studied on different levels and with different methods. Upfront and early surrogate predictive markers of activity/efficacy can be studied on tumor tissue, tumor imaging, and peripheral blood. mTOR pathways alterations, circulating endothelial cells, and other circulating angoigenic factors will be correlated with clinical outcome. Tumor perfusion and circulating markers will be studied also as markers of response compared with the morphological imaging.

Conditions

  • Pancreatic Neuroendocrine Tumour Metastatic

Interventions

DRUG

Everolimus 10 mg daily

everolimus is a recently approved mTOR inhibitor in advanced progressing well/moderately differentiated pancreatic neuroendocrine tumors

Sponsors & Collaborators

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Nicola Fazio, MD,PhD · European Institute of Oncology

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2017-01-12
Completion
2018-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02305810 on ClinicalTrials.gov