Abstract
Objective: This was a single-institution, phase II, Simon 2-stage with safety lead-in study of the oral androgen-receptor (AR+) antagonist, enzalutamide, in patients with recurrent AR+ ovarian cancer with measurable disease and 1–3 prior lines of chemotherapy. The primary objective was to determine the proportion of patients surviving progression free for 6 months (PFS6) and overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, with 7/58 responses or PFS6 of 13 being considered a positive study.
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