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Efficacy and Safety of Everolimus (RAD001) Compared to Placebo in Patients With Advanced Neuroendocrine Tumors

NCT00510068 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2015-07-01

Study results available
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Summary

The purpose of this study was to evaluate progression free survival in those participants assigned everolimus 10 mg/day plus Best Supportive Care versus those assigned to placebo plus Best Supportive Care in Advanced Neuroendocrine Tumors of pancreatic origin.

Conditions

  • Advanced Neuroendocrine Tumors of Pancreatic Origin

Interventions

DRUG

Everolimus

A 10-mg dose of everolimus was given by continuous oral daily dosing of two 5-mg tablets.

DRUG

Everolimus Placebo

a 10-mg dose of matching placebo to Everolimus was given by continuous oral daily dosing of two 5-mg tablets.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2010-02-28
Completion
2014-03-31

Countries

  • United States
  • Belgium
  • Brazil
  • Canada
  • France
  • Germany
  • Greece
  • Italy
  • Japan
  • Netherlands
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

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 NCT00510068 on ClinicalTrials.gov