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news.Novacea has reported preliminary findings from its Ascent-2 Phase III clinical trial, which compared Asentar in combination with Taxotere chemotherapy to Taxotere alone in patients with androgen-independent prostate cancer.
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The Ascent-2 trial was terminated by Novacea in November 2007 due to an unexplained imbalance of deaths between the treatment and control arms of the trial. Ascent-2 was an open-label trial that randomized patients to either combination therapy with Asentar and Taxotere or Taxotere alone.
As of the termination date of Ascent-2, Novacea had enrolled over 950 of the planned total enrollment of 1,200 androgen-independent prostate cancer (AIPC) patients in the trial at multiple centers in various countries, including the US, Canada, Germany, and Central Europe.
Novacea’s preliminary evaluation of the Ascent-2 data reflects median survival of 16.7 months in the treatment arm, which included Asentar in combination with once-weekly Taxotere, as compared to median survival of 18.5 months in the control arm of the study, in which Taxotere was administered every three weeks.
In the treatment arm of Ascent-2, 11.5% of AIPC patients completed their planned treatment, as compared to 21% of AIPC patients who completed their planned treatment in the control arm of the study. The overall incidence of grade 3 (severe) and grade 4 (life-threatening or disabling) adverse events was 51.4% in the treatment arm, as compared to 50% in the control arm.
Edward Schnipper, executive vice president and chief medical officer of Novacea, said: “We are in the process of updating our data analyses and preparing a complete response to the FDA regarding releasing the clinical hold on the Asentar investigational new drug application.”