MITO-11: A randomized multicenter phase II trial testing the addition of pazopanib to weekly paclitaxel in platinum-resistant or -refractory advanced ovarian cancer (AOC).

5503^ Background: few drugs are available for patients (pts) with platinum resistant or refractory AOC; their efficacy is scanty. Evidence on antiangiogenic drugs efficacy in AOC is increasing. Pazopanib is an oral multi-kinase inhibitor of VEGFR-1, -2, -3, PDGFR-α and -β and c-Kit with antiangiogenic properties. Methods: AOC pts with disease progressing during or within 6 months from the last platinum-based chemotherapy, aged≤75, ECOG PS 0-1 were eligible for a multicenter comparative randomized phase 2 trial of weekly paclitaxel (wP, 80 mg/m² dd 1, 8, 15 q 28) vs wPP (wP + pazopanib 800 mg/day); both treatments could continue until progression. Primary endpoint was progression-free survival (PFS). With 61 events, the trial would have 80% power to detect a 0.65 hazard ratio (HR), prolonging median PFS from 3 to 4.6 months with one-tail alfa = 0.20; 72 pts were planned. Partially supported by GSK. Clinicaltrials.gov NCT 01644825. Results: 74 pts (37 in each arm) were enrolled by 11 centers. Median age 57;...