drugset / Trial / NCT02687958

Study of Everolimus as Maintenance Therapy for Metastatic NEC With Pulmonary or Gastroenteropancreatic Origin

NCT02687958 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

Cisplatin and Etoposide is the standard of care in NEC originating from the gastro-intestinal tract and lung, based on retrospective studies. Nevertheless the prognosis of this group of patients is still poor with median survival of less than 20 months. Everolimus is an mammilian target of rapamycin (mTOR) inhibitor that has been demonstrated to be active in patients with well and moderately differentiated primitive neuroectodermal tumor (pNET). Recently, the Investigators demonstrated that the mammilian target of rapamycin (mTOR) pathway is overexpressed in NEC. Based on the activity of Everolimus in the treatment of patients with well and moderately differentiated p-NET and on the evidence that even poorly differentiated forms express the pathway of m-TOR is conceivable that Everolimus could be active even in NEC.

Timeline

Start
2015-05
Primary completion
2022-12
Completion
2023-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule 10 mg —