CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Everolimus (RAD001) , Afinitor®drug
Likely dose
Everolimus (RAD001) , Afinitor® 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/NCT01419639
NCT01419639Phase 2Completed
CompareCT.gov

Phase II Study of Everolimus (RAD001) in Children and Adults With Neurofibromatosis Type 2

NYU Langone Health·interventional·Posted Aug 18, 2011·Updated Jul 18, 2017

In Brief

A Phase 2 clinical trial evaluating Everolimus (RAD001) , Afinitor® for Neurofibromatosis Type II. Completed, enrolled 10 participants across 1 site.

Detailed Summary

This trial studies whether Everolimus is efficacious in treating neurofibromatosis 2.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeurofibromatosis Type II
CountriesUnited States
CollaboratorsNovartis Pharmaceuticals, The Children's Tumor Foundation

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 18, 2011
Enrollment StartOct 1, 2011
Primary CompletionDec 1, 2012
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.9 years ago

Interventions

Everolimus (RAD001) , Afinitor®drug

Everolimus will be provided by Novartis. Everolimus is formulated as tablets for oral administration of 2.5 mg, 5 mg, 10 mg strength. Everolimus will be self-administered (by the patients themselves) or administered by the patient's parent or guardian (for minors). The investigator will instruct the patient to take the study drug exactly as specified in the protocol. Depending the age-based dosing schedule, everolimus should be administered orally once (or twice) daily, preferably in the morning (and evening), at the same time every day with our without food. Everolimus tablets should be swallowed whole with a glass of water. The tablets must not be chewed or crushed. In cases where tablets can not be swallowed, the tablets should be disintegrated in water just prior to being taken. Everolimus will be administered orally as per the age-based dosing schedule continuously from study day 1 until progression of disease or unacceptable toxicity.