1. 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

2. 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

3. Centri MITO – final enrollment figures