Pharmacokinetics, Activity, And Safety Of Odm-201 In Chemotherapy-Naive Patients With Metastatic Castration-Resistant Prostate Cancer: An Open-Label Phase I Trial With Long-Term Extension.

230 Background: The open phase I trial, ARAFOR, with long-term extension evaluated pharmacokinetics (PK), antitumor activity and safety of ODM-201 in chemotherapy-naive patients with progressive mCRPC. Methods: PK phase: Patients received one 600 mg dose of ODM-201 capsules (6 x 100 mg) in fed state and one dose of either tablet formulation (TabA or TabB, 2 x 300 mg) in fed and fasted state in random order. Extension: Patients received ODM-201 600 mg (capsule) twice daily until disease progression/ intolerable adverse event (AE). A data cut-off date Apr 4, 2014 was used for analyses. Results: 30 patients were enrolled in PK and treated in the extension phase. Baseline characteristics: median age 68 yrs, ECOG score 0 in 67%, and ECOG 1 in 33% patients, median PSA 18.2 ng/mL. Median time from PC diagnosis to start of ODM-201 treatment was 39 months. Median time on ODM-201 treatment was 9.5 months (trial is on-going). ODM-201 plasma concentration–time curves were similar for the capsule, TabA, and TabB at fe...