10
Participants
Start Date
October 31, 2011
Primary Completion Date
December 31, 2012
Study Completion Date
December 31, 2013
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.
New York University Medical Center, New York
Collaborators (1)
Novartis Pharmaceuticals
INDUSTRY
The Children's Tumor Foundation
OTHER
NYU Langone Health
OTHER