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Pivotal Phase III Trial of Novartis Drug Afinitor® Met Primary Endpoint in Study of Patients With Advanced Pancreatic Neuroendocrine Tumors
Date:6/2/2010

from the RADIANT-3 study will be submitted for presentation at the European Society for Medical Oncology annual meeting taking place in Milan, Italy in October. Additionally, worldwide regulatory filings are planned for 2010.

Study details

RADIANT-3 is a Phase III prospective, double-blind, randomized, parallel group, placebo-controlled, multicenter study. The trial examined the efficacy and safety of everolimus plus best supportive care versus placebo plus best supportive care in 410 patients with advanced pancreatic NET, also known as islet cell tumors. Patients who met the study's entry criteria were randomized 1:1 to receive either daily everolimus (10 mg) or daily placebo orally.

The primary endpoint of RADIANT-3 is progression-free survival. Secondary endpoints include safety, objective response rate and overall survival.

About neuroendocrine tumors

Neuroendocrine tumors arise from cells that can produce and secrete a variety of hormones that regulate bodily functions. There are many types of NET that can occur throughout the body; however, most are found in the gastrointestinal tract, pancreas and lungs(3). Because NET are relatively rare, there is no routine screening and patients often experience delays of five to seven years before receiving an accurate diagnosis(3),(4). As a result of this, patients with NET often have advanced disease when diagnosed(3). Although considered a rare cancer, the incidence of NET is increasing dramatically, having quadrupled in the past 30 years(3).

About everolimus

In the US, everolimus is approved under the trade name Afinitor® (everolimus) tablets for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of treatment
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SOURCE Novartis Pharmaceuticals Corporation
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