ARRAY-162-311 The MILO Study Study Design Schema Patients with recurrent or persistent low‑grade serous carcinomas of the ovary, fallopian tube or primary peritoneum Must have received prior platinum-containing therapy, but no more than 3 prior chemotherapies; unlimited prior hormonal therapy N = 360 Binimetinib 45 mg BID N = 240 Randomization 2:1 Physician’s Choice Chemo (paclitaxel, topotecan or pegylated liposomal doxorubicin) N = 120 Stratification Platinum-free interval Prior systemic treatment CROSSOVER Binimetinib 45 mg BID Primary endpoint: Progression-free Survival by Blinded Independent Central Review Secondary endpoints: Overall Survival, ORR, DOR, DCR, Safety, PK, QOL MILO: MEK Inhibitor in Low Grade Serous Ovarian Cancer 1 confidential
Study terminated 1 april 2016 Study interupted 1 april 2016 after planned futility analysis Final enrollment 341 randomized of 360 planned Data base will be definitvely closed 29 June 2016 Confidential
Centri MITO – final enrollment figures