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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.

A 400-patient, international phase III trial 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).

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