CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 302 enrolled
Drug / intervention
Everolimus +2 moredrug
Likely dose
Everolimus 10 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.

Search/NCT01524783
NCT01524783Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Multicenter, Phase III Study of Everolimus (RAD001) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced NET of GI or Lung Origin

Novartis Pharmaceuticals·interventional·Posted Feb 2, 2012·Updated Aug 5, 2021

In Brief

A Phase 3 clinical trial evaluating Everolimus, Placebo, and 1 other intervention for Advanced NET of GI Origin and 2 related conditions. Completed, enrolled 302 participants across 97 sites in 25 countries.

Detailed Summary

The purpose of this study is to compare the antitumor activity of everolimus plus best supportive care versus placebo plus best supportive care in patients with progressive nonfunctional neuroendocrine tumor (NET) of gastrointestinal (GI) or lung origin without a history of, or current symptoms of carcinoid syndrome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced NET of GI Origin, Advanced NET of Lung Origin, Neuroendocrine Tumors
CountriesAustria, Belgium, Canada, China, Colombia, Czechia, Germany, Greece, Hungary, Italy, Japan, Lebanon, Netherlands, Poland, Russia, Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2, 2012
Enrollment StartMar 30, 2012
Primary CompletionNov 28, 2014
Study CompletionAug 7, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 14.4 years ago

Interventions

Everolimusdrug

Participants were treated with everolimus 10 mg (two 5 mg tablets) once daily orally taken

Placebodrug

Participants were treated with two tablets of matching placebo once daily orally taken.

Best suportive care (BSC)other

Best supportive care includes all care provided to participants deemed necessary by the treating physician, such as but not restricted to anti-diarrheals and analgesics. The optimal care of the patient is based on the treating physician's best medical judgment.