Conditions: Islet Cell Tumor
Keywords: Pancreatic Neuroendocrine tumors PNET Pasireotide Everolimus Advanced progressive pancreatic neuroendocrine tumor
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 160
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im arm 2: everolimus 10 mg once daily po alone

Interventions: intervention 1: Everolimus intervention 2: Pasireotide LAR
Intervention descriptions: intervention 1: Everolimus was supplied as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets intervention 2: Pasireotide LAR intra-muscular depot injections were supplied as a powder in vials containing 20 mg and 40 mg with ampoules containing 2 mL of vehicle (for reconstitution).

Protocol document: