Methods
The studies underwent formal IRB review and were registered at clinicaltrials.gov (Sensitive: NCT01033123; Resistant: NCT01033292). Each study was designed as a multi-center, single-arm phase 2 using a Simon 2-stage design. In both studies, the primary endpoint was objective response rate (ORR), evaluated in all patients who received at least 1 dose of study drug and had 2 post-baseline assessments or progression/death within 60 days of last assessment. Secondary endpoints were progression free survival (PFS) and safety using NCI-CTCAE v3.0. A CA125 response was defined as 50% fall in CA125 initially >2× ULN and maintained for at least 28 days. A prospectively planned exploratory analysis of the relation between 