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Clinical Trial Results

Summaries of Newsworthy Clinical Trial Results
  • Posted: 07/30/2008

Everolimus Extends Progression-Free Survival in Advanced Kidney Cancer

Adapted from the NCI Cancer Bulletin 1.

A 400-patient, international phase III trial 2 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 3).

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 4 (Nexavar) and sunitinib 5 (Sutent). Trial participants may also have been treated with bevacizumab 6 (Avastin) and interferon.

Related Pages



Glossary Terms

everolimus (eh-veh-ROH-lih-mus)
A drug used to treat certain types of pancreatic cancer. It is also used to treat a type of advanced kidney cancer and to treat subependymal giant cell astrocytoma in some patients. It is being studied in the treatment of other types of cancer and other conditions. Everolimus stops cancer cells from dividing and may prevent the growth of new blood vessels that tumors need to grow. It also lowers the body’s immune response. It is a type of kinase inhibitor, a type of angiogenesis inhibitor, and a type of immunosuppressant. Also called Afinitor and RAD001.
primary endpoint (PRY-mayr-ee ...)
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.
progression-free survival (pruh-GREH-shun ... ser-VY-vul)
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works. Also called PFS.
significant (sig-NIH-fih-kunt)
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.

Table of Links

1http://www.cancer.gov/ncicancerbulletin
2http://www.cancer.gov/clinicaltrials/search/view?version=healthprofessional&
;cdrid=527261
3http://www.ncbi.nlm.nih.gov/pubmed/18653228?ordinalpos=1&itool=EntrezSystem
2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
4http://www.cancer.gov/cancertopics/druginfo/sorafenibtosylate
5http://www.cancer.gov/cancertopics/druginfo/sunitinibmalate
6http://www.cancer.gov/cancertopics/druginfo/bevacizumab
7http://www.cancer.gov/clinicaltrials/search
8http://www.cancer.gov/cancertopics/types/kidney