A Phase II Study of Everolimus for Previously Untreated Sporadic Angiomyolipomas of the Kidney

Full Title

A Phase II study of Sporadic Angiomyolipomas (AMLs) Growth Kinetics While on Everolimus Therapy (SAGE)


Angiomyolipomas (AMLs) are the most common non-cancerous tumors of the kidney. They are composed of blood vessels, muscle cells, and fat cells. The purpose of this study is to see if the drug everolimus is safe and effective in people with sporadic AMLs who have not yet received treatment.

Everolimus inhibits a molecule called mTOR, which helps cancer cells grow. It is already approved for treating an advanced form of kidney cancer called renal cell carcinoma, as well as AMLs associated with a genetic disorder called tuberous sclerosis complex. Its use in this study is considered investigational. Everolimus is taken orally (by mouth).


To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have an AML that is greater than 3 cm in size.
  • Patients may not have received prior treatment for their AML.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. A. Ari Hakimi at 646-422-4497.