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