Overview

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

Status:
Completed
Trial end date:
2018-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
European Institute of Oncology
Treatments:
Everolimus
Sirolimus
Criteria
Inclusion Criteria:

1. Histological diagnosis of metastatic well/moderately differentiated pancreatic
neuroendocrine tumor

2. Patient incoming to be treated with everolimus outside clinical trials or within a
clinical trial that permits the concurrent inclusion in an ancillary trial

3. Written informed consent must be signed and dated by the patient and the investigator
prior to inclusion.

Exclusion Criteria:

1. Patients with poorly differentiated neuroendocrine carcinoma, adenocarcinoid, goblet
cell carcinoid, small cell carcinoma, Merkel cell carcinoma.

2. Patients with pancreatic NETs not eligible to be treated with everolimus

3. Patients with ongoing everolimus treatment

4. Prior therapy with mTOR inhibitors