Open-label, phase i dose-escalation study of sodium selenate, a novel activator of PP2A, in patients with castration-resistant prostate cancer

Abstract

Background: Angiogenesis is fundamental to the progression of many solid tumours including prostate cancer. Sodium selenate is a small, water-soluble, orally bioavailable activator of PP2A phosphatase with anti-angiogenic properties. Methods: This was a dose-escalation phase I study in men with asymptomatic, chemotherapy-nave, castration-resistant prostate cancer. The primary objective was to determine the maximum tolerated dose (MTD). Secondary objectives included establishing the safety, tolerability and pharmacokinetic profile. Results: A total of 19 patients were enrolled. The MTD was 60 mg per day. Dose-limiting toxicity (fatigue and diarrhoea) was observed at 90 mg per day. The most fr..