Phase I/II ARADES trial of new-generation anti-androgen presented at ESMO congress
Dr Christophe Massard, investigator in the ODM-201 ARADES trial, has presented initial results from the Phase I component of the ARADES trial at the ESMO 2012 Congress (European Society for Medical Oncology), in Vienna, Austria. The ARADES trial is a first-in-man, open-label, Phase I/II safety, pharmacokinetic and proof-of-concept study of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (mCRPC). Based on the Phase I results, expansion of the ARADES study (Phase II component) started in June 2012 and is ongoing in multiple European countries and in the US. The ARADES trial is sponsored by Orion and Endo Pharmaceuticals, a subsidiary of Endo Health Solutions.
According to data from the Phase I component, ODM-201 has been well-tolerated, with no significant treatment-related adverse events. Prostate specific antigen (PSA) response (defined as >=50 per cent PSA decrease) was obtained in 13 (87 per cent) of 15 patients currently evaluable at 12 weeks. All six docetaxel-pre-treated patients had a PSA decrease at 12 weeks. All evaluable patients so far achieved a partial response or remained stable, according to a set of published rules that define when cancer patients improve, stay the same, or worsen during treatments, at 12 weeks.