Exposure-Response Relationship Of Open-Label (Ol) Amg 386 Monotherapy In Patients (Pts) With Recurrent Ovarian Cancer

5072 Background: AMG 386, an investigational peptibody, inhibits tumor angiogenesis by preventing angiopoietins 1/2 and Tie2 receptor interaction. A phase II, double-blind, controlled study (NCT00479817) evaluated toxicity and efficacy of AMG 386 + paclitaxel (P) in recurrent ovarian cancer pts. Increased AMG 386 exposure in that study was associated with longer progression-free survival (PFS; Lu et al., JCO 2010; 28 [Suppl]: 5042). Here, these analyses were applied to pts electing OL AMG 386 monotherapy after progression in the placebo group. Methods: Pts with recurrent epithelial ovarian, fallopian tube, or peritoneal cancer (≤3 prior anticancer therapies, GOG ≤1) were randomized 1:1:1 to P IV QW (3 on/1 off) + AMG 386 (3 or 10 mg/kg) or placebo IV QW. In the placebo group, pts who progressed and stayed eligible could receive OL AMG 386 10 mg/kg IV QW monotherapy. In pts receiving AMG 386 monotherapy, post-hoc analyses evaluated PFS per RECIST, objective response rate (ORR), adverse events (AEs), and th...