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Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor

NCT00412061 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 429

Last updated 2014-11-21

Study results available
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Summary

The purpose of this study was to evaluate whether everolimus 10 mg / day added to treatment with depot octreotide prolongs progression free survival compared to treatment with octreotide alone in patients with advanced carcinoid tumor.

Conditions

  • Carcinoid Tumor
  • Malignant Carcinoid Syndrome

Interventions

DRUG

Octreotide

Octreotide 30 mg intramuscularly (i.m.) every 28 days.

DRUG

Placebo

A 10-mg oral daily dosing regimen (two 5-mg tablets) of matching placebo.

DRUG

Everolimus

A 10-mg oral daily dosing regimen (two 5-mg tablets) of everolimus.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2010-04-30
Completion
2013-06-30

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • Finland
  • France
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

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 NCT00412061 on ClinicalTrials.gov