At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 429 enrolled
Drug / intervention
Octreotide +2 moredrug
Likely dose
Octreotide 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind Placebo-controlled, Multicenter Phase III Study in Patients With Advanced Carcinoid Tumor Receiving Octreotide Depot and Everolimus 10 mg/Day or Octreotide Depot and Placebo
In Brief
A Phase 3 clinical trial evaluating Octreotide, Placebo, and 1 other intervention for Carcinoid Tumor and Malignant Carcinoid Syndrome. Completed, enrolled 429 participants across 70 sites in 15 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoid Tumor, Malignant Carcinoid Syndrome
CountriesAustralia, Belgium, Canada, Czechia, Finland, France, Germany, Greece, Italy, Netherlands, Slovakia, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2006
First PostedDec 2006
Primary CompletionApr 2010
Study CompletionJun 2013
TodayJul 2026
First PostedDec 15, 2006
Enrollment StartDec 1, 2006
Primary CompletionApr 1, 2010
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.5 years ago
Interventions
Octreotidedrug
Octreotide 30 mg intramuscularly (i.m.) every 28 days.
Placebodrug
A 10-mg oral daily dosing regimen (two 5-mg tablets) of matching placebo.
Everolimusdrug
A 10-mg oral daily dosing regimen (two 5-mg tablets) of everolimus.