CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 34 enrolled
Drug / intervention
Everolimus +1 moredrug
Likely dose
Everolimus 2.5 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/NCT01789281
NCT01789281Phase 4Completed
CompareCT.gov

An Open-label, Multi-center Everolimus Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Everolimus Study and Are Judged by the Investigator to Benefit From Continued Everolimus Treatment

Novartis Pharmaceuticals·interventional·Posted Feb 12, 2013·Updated Jun 11, 2021

In Brief

A Phase 4 clinical trial evaluating Everolimus and Sandostatin LAR Depot for Neoplasms. Completed, enrolled 34 participants across 24 sites in 9 countries.

Detailed Summary

Study to allow access to everolimus for patients who are on everolimus treatment in a Novartis-sponsored study and are benefiting from the treatment as judged by the investigator

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesCzechia, Italy, Netherlands, Russia, South Korea, Spain, Thailand, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 12, 2013
Enrollment StartMay 14, 2013
Primary CompletionAug 28, 2020
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 13.4 years ago

Interventions

Everolimusdrug

Everolimus was provided by the investigator in 2.5 mg, 5 mg or 10 mg tablets for daily oral administration. The starting dose of everolimus was the same as the last dose that was given in the parent study. Dose modification thereafter was done at the discretion of the Investigator based upon what is in the subject's best interest.

Sandostatin LAR Depotdrug

Sandostatin LAR Depot was provided by Novartis or by the investigational site considering local regulations. The dose and frequency of Sandostatin LAR Intramuscular injections was the same as the last dose that was given in the parent study.