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Postitive trial results for Novartis


Data released following a clinical trial has shown that Afinitor (also known as RAD001, everolimus) halted tumor growth in 55% of patients with advanced gastric cancer, a condition for which there are limited treatment options.

In addition 45% of patients in the study demonstrated some tumor shrinkage.

The data will be presented at the American Society of Clinical Oncology’s 2009 Gastrointestinal Cancers Symposium on January 15, 2009.

The open label, single arm, multi-centre phase II study of 54 patients conducted in Japan, is designed to assess the efficacy and safety of Afinitor in patients with advanced gastric cancer whose disease progressed despite prior treatment.

Patients enrolled in the trial were heavily pretreated. All trial participants were from Japan and of Asian descent.

“There are very limited treatment options for patients who progressed despite the standard treatment for this aggressive cancer,” said Atsushi Ohtsu, director, Research Center for Innovative Oncology, National Cancer Center Hospital East, Chiba, Japan.

“The results from this study demonstrate that Afinitor has the potential to provide an effective new option for these patients.”

A global phase III clinical trial program to evaluate the efficacy and safety of Afinitor monotherapy in approximately 500 advanced gastric cancer patients will begin enrollment this year.

For more information on this clinical trial please click on the link below:

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