drugset / Trial / NCT01374451

Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET

NCT01374451

Phase 2 Terminated 160 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will estimate the treatment effect of everolimus in combination with pasireotide LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced progressive PNET. A planned primary analysis was completed with data cut of 02-Apr-2014. The study did not meet its primary objective, which was based on progression-free survival (PFS) as per local radiology assessment and was prematurely terminated with the last patient last visit on 19-Feb-2015. However, it is important to note that the data did not reveal any new safety concerns. It was decided to stop the study and this decision was shared with the study sites on 31-Jul-2014.

Timeline

Start
2011-06
Primary completion
2015-02
Completion
2015-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule 10 mg Oral
Subject Pasireotide Other / unclassified 60 mg Intramuscular