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

NCT01628913 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2016-04-07

Study results available
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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).

Conditions

  • Pancreatic Neuroendocrine Tumors (pNET)

Interventions

DRUG

BEZ235

BEZ235 400 mg bid p.o. (by mouth, twice daily)

DRUG

Everolimus

Everolimus 10 mg qd p.o. (by mouth, daily)

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States
  • France
  • Italy
  • Netherlands
  • Russia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01628913 on ClinicalTrials.gov