Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1)

Inclusion Criteria:

All Ages
Definite diagnosis of Tuberous Sclerosis according to the modified Gomez criteria
At least one Subependymal Giant Cell Astrocytoma of at least 1 cm in diameter
Evidence of SEGA worsening as compared to prior MRI scans
Females of child bearing potential must use birth control
Written informed consent

Exclusion Criteria:

SEGA related surgery is likely to be required in the opinion of the investigator
Recent heart attack, cardiac related chest pain or stroke
Severely impaired lung function
Severe liver dysfunction
Severe kidney dysfunction
Pregnancy or breast feeding
Current infection
History of organ transplant
Surgery within two months prior to study enrollment
Prior therapy with a medication in the same class as Everolimus
Uncontrolled high cholesterol
Uncontrolled diabetes
HIV
Patients with metal implants thus prohibiting MRI evaluations

Other protocol-defined inclusion/exclusion criteria may apply