A Study to Determine the Effectiveness of Escalating Doses of RAD001 (Everolimus) in Patients With Lymphangioleiomyomatosis

Inclusion Criteria:

• Female aged >/= 18 years with a diagnosis of LAM
• Pulmonary function abnormalities as follows:
• FEV1 of ≤ 80% of the predicted value following administration of a standard dose of a short acting β2-agonist (*200 µg Salbutamol, measured between 10 and 15 minutes of inhalation) OR
• FEV1 < 90% of the predicted value of bronchodilator following administration of a standard dose of a short acting β2-agonist (*200 µg Salbutamol, measured between 10 and 15 minutes of inhalation) and DLco (uncorrected) <80% predicted.
• Female patients including those of childbearing potential will be included in this study.
• Negative pregnancy test at screening and baseline

Exclusion Criteria:

• FEV1<50% of predicted post-bronchodilator.
• Change in FVC (ml) > ± 15% of screening value at baseline visit (not less than 14d after screening visit).
• Use of any medicine containing estrogen in the 4 months prior to the screening visit and for the duration of the study
• Significant hematologic, renal, hepatic laboratory abnormality or amylase > 1.5x the upper limit of the normal range at the screening or baseline visits
• Fasting blood glucose > 126mg/dl or random blood glucose >200mg/dl at screening and/or baseline
• Recent surgery (involving entry into a body cavity or requiring sutures) within 2 months of the screening visit or any evidence of unhealed surgical wound.
• Uncontrolled hyperlipidemia (defined as persistent elevation of total cholesterol or triglycerides >6.5nM/L) or a history of clinical atherosclerotic disease including heart attack, angina, peripheral vascular disease or stroke.
• Previous organ transplantation
• Inability to give informed consent
• Inability to perform pulmonary function or 6 minute walk tests and imaging assessments

Other protocol-defined inclusion/exclusion criteria may apply