Dosing and Effectiveness Study of Sorafenib and RAD001 in the Treatment of Patients With Advanced Kidney Cancer

The drugs used in this trial are called targeted drugs as they target specific activities
that are carried out by cancer cells that make them grow and spread. Sorafenib is an
approved drug for the treatment of advanced kidney cancer. RAD001 is an experimental drug
that has been used in other research studies with other types of cancer. In this trial, the
use of RAD001 and sorafenib together for the treatment of kidney cancer is experimental. In
the Phase I portion of this study 13-16 patients will be treated with the same dose of
sorafenib and different doses of RAD001. The purpose is to see what is a safe dose of
RAD001 when combined with sorafenib in the treatment of kidney cancer. Once this dose of
RAD001 is determined, about 65 more patients will be treated to see how effective this
combination of drugs is against this kidney cancer.

Both of these drugs are taken by mouth. Sorafenib will be taken twice a day. RAD001 is
taken by mouth weekly. Patients will be able to continue treatment as long as their disease
does not worsen or side effects become intolerable.