FDAnews
www.fdanews.com/articles/100635-novacea-halts-ascent-2-trial-in-advanced-prostate-cancer

Novacea Halts ASCENT-2 Trial in Advanced Prostate Cancer

November 5, 2007

Novacea has ended its Phase III ASCENT-2 clinical trial of Asentar, the company’s treatment for patients with androgen-independent prostate cancer, due to an imbalance of deaths between the two treatment arms.

The company and its partner, Schering-Plough, will analyze data to attempt to understand the cause of the higher death rate in the Asentar plus Taxotere (docetaxel) group. The study was comparing the benefits of weekly Asentar plus Taxotere to the current standard of care, Novacea said.

More than 900 of the planned total of 1,200 patients were enrolled in this study at multiple centers in the U.S., Canada, Germany and central Europe.