NCT01374451

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

A Randomized, Open-label Phase II Multicenter Study Evaluating the Efficacy of Oral Everolimus Alone or in Combination With Pasireotide LAR i.m. in Advanced Progressive Pancreatic Neuroendocrine Tumors (PNET) - The COOPERATE-2 Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Islet Cell Tumor

Interventions

Type	Name	Description
DRUG	Everolimus	Everolimus was supplied as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets
DRUG	Pasireotide LAR	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).

Timeline

• Start date: 2011-06-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2011-06-16
• Last updated: 2016-12-20
• Results posted: 2016-12-20

Locations

47 sites across 19 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Denmark, France, Germany, Hungary, Italy, Japan, Netherlands, New Zealand, Spain, Sweden, Thailand, Turkey (Türkiye), United Kingdom