Related Pages Search for Clinical Trials 1 NCI's PDQ® Cancer Clinical Trials Registry. Kidney Cancer Home Page 2 NCI's gateway for information about kidney cancer.

Adapted from the NCI Cancer Bulletin, vol. 5/no. 6, March 18, 2008 (see the current issue ³).

A 400-patient, international phase III trial ⁴ testing the drug everolimus in patients with advanced kidney cancer was stopped after meeting its primary endpoint, the drug's manufacturer, Novartis, reported February 28, 2008.

Results of the trial were published by the Lancet on July 23, 2008 (see the journal abstract ⁵).

The trial's Independent Data Monitoring Committee recommended that the trial be halted and patients in the placebo arm of the study be offered everolimus after an interim analysis showed a significant improvement in progression-free survival in patients given everolimus.

Everolimus, also known as RAD001, inhibits mTOR, a protein that regulates tumor cell division and angiogenesis.

Patients in this cancer trial had advanced, progressive disease despite treatment with other recently approved agents for advanced kidney cancer, including sorafenib ⁶ (Nexavar) and sunitinib ⁷ (Sutent). Trial participants may also have been treated with bevacizumab ⁸ (Avastin) and interferon.

Glossary Terms

A drug used to treat advanced kidney cancer that did not respond to treatment with certain other anticancer drugs. It is also being studied in the treatment of other types of cancer. Everolimus stops cancer cells from dividing and may block the growth of new blood vessels that tumors need to grow. It also decreases the body’s immune responses. It is a type of immunosuppressant and a type of antiangiogenesis agent. Also called Afinitor and RAD001.

The main result that is measured at the end of a study to see if a given treatment worked (e.g., the number of deaths or the difference in survival between the treatment group and the control group). What the primary endpoint will be is decided before the study begins.

The length of time during and after treatment in which a patient is living with a disease that does not get worse. Progression-free survival may be used in a clinical study or trial to help find out how well a new treatment works. Also called PFS.

In statistics, describes a mathematical measure of difference between groups. The difference is said to be significant if it is greater than what might be expected to happen by chance alone. Also called statistically significant.