Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)

Inclusion Criteria: * Male or Female 18 years or older * Clinically definite diagnosis of Tuberous Sclerosis Complex according to the modified Gomez criteria or sporadic LAM (biopsy-proven or compatible chest CT scan) * Clinically definite diagnosis of renal angiomyolipoma * At least one Angiomyolipoma of ≥ 3 cm in its longest diameter using CT or MRI * Females of child bearing potential must use birth control and have documentation of negative pregnancy test * Written informed consent according to local guidelines Exclusion Criteria: * Recent heart attack, cardiac related chest pain or stroke * Severely impaired lung function * Bleeding related to angiomyolipoma or embolization during 6 months prior to randomization * Clinically significant chylous ascites * Clinically significant hematological or hepatic abnormality * 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 * Recent use of an investigational drug * Bleeding diathesis or on oral anti-vitamin K medication * Uncontrolled high cholesterol * Uncontrolled diabetes * HIV * Inability to attend scheduled clinic visits * Patients with metal implants thus prohibiting MRI evaluations * Angiomyolipoma which requires surgery at the time of randomization * History of malignancy * Severe or uncontrolled medical conditions which…