drugset / Trial / NCT02305810

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

NCT02305810 ↗

Phase 2 Completed 54 enrolled European Institute of Oncology
NaSingle-groupOpen-labelBasic science

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule 10 mg —