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