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 would cause an unacceptable safety risk or compromise compliance with the protocol