A phase II trial of iniparib (BSI-201) in combination with gemcitabine/carboplatin (GC) in patients with platinum-sensitive recurrent ovarian cancer.

5004 Background: GC is an established chemotherapy combination for patients with platinum-sensitive recurrent ovarian cancer, with an associated overall response rate (ORR) of 47.2% (Pfisterer et al. JCO 2006; 24:4699). Addition of iniparib (BSI-201), an anticancer agent with poly(ADP-ribose) polymerase inhibitory activity, to GC potentiates the activity of GC alone, with low incremental toxicities, in patients with metastatic triple-negative breast cancer (O’Shaughnessy et al. NEJM 2011). This study was designed to evaluate the efficacy and safety of iniparib in combination with GC in patients with platinum-sensitive recurrent ovarian cancer. Methods: This multicenter, single-arm phase 2 study used a Simon two-stage design (Stage I n=17; total N=41). Eligible patients were ≥18 years with a histological diagnosis of epithelial ovarian carcinoma, fallopian tube cancer, or primary peritoneal carcinoma and demonstration of platinum-sensitive disease, defined by relapse ≥6 months following primary treatment t...