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

PHASE2CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2013

Conditions
Neurofibromatosis Type II
Interventions
DRUG

Everolimus (RAD001) , Afinitor®

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.

Trial Locations (1)

10016

New York University Medical Center, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

collaborator

The Children's Tumor Foundation

OTHER

lead

NYU Langone Health

OTHER