An Open-Label, Multi-Center, Expanded Access Study of RAD001 in Patients With Metastatic Carcinoma of the Kidney Who Are Intolerant of or Have Progressed Despite Any AvailableVascular Endothelial Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy

Inclusion Criteria

Inclusion criteria:

- ≥ 18 years old; metastatic renal cancer, intolerant of or failed sunitinib and/or
sorafenib

- Adequate bone marrow function, liver function, renal function

- Adequate birth control

Exclusion criteria:

- Previously received RAD001 or other mTOR inhibitors, known hypersensitivity to
rapamycin, chronic systemic treatment with corticosteroids or immunosuppressive
agents (prednisone ≤ 20 mg/day for adrenal insufficiency OK

- Topical or inhaled steroids OK)

- Active bleeding

- Uncontrolled angina, CHF, heart attack ≤ 6 months, uncontrolled diabetes

Other protocol-defined inclusion/exclusion criteria may apply