NCT01628913

Efficacy and Safety of BEZ235 Compared to Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumors

Randomized Phase II Study of BEZ235 or Everolimus in Advanced Pancreatic Neuroendocrine Tumors

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a multicenter, open label, randomized phase II study to evaluate the efficacy and safety of BEZ235 as compared to everolimus in patients with advanced, low to intermediate grade pancreatic neuroendocrine tumor (pNET).

Detailed description

Patients with advanced (unresectable or metastatic), low to intermediate grade (histologically confirmed well and moderately differentiated) pancreatic neuroendocrine tumor (pNET) were randomized to either BEZ235 or everolimus. The study was planned to include 140 patients, with 70 patients in the BEZ235 treatment group and 70 patients in the everolimus treatment group. An interim analysis was conducted on 62 randomized patients. The study was terminated as the BEZ235 treatment did not demonstrate a progression free survival advantage to everolimus treatment.

Conditions

• Pancreatic Neuroendocrine Tumors (pNET)

Interventions

Type	Name	Description
DRUG	BEZ235	BEZ235 400 mg bid p.o. (by mouth, twice daily)
DRUG	Everolimus	Everolimus 10 mg qd p.o. (by mouth, daily)

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2012-06-27
• Last updated: 2016-04-07
• Results posted: 2016-04-07

Locations

26 sites across 8 countries: United States, France, Italy, Netherlands, Russia, Spain, Switzerland, United Kingdom