Recruitment
The study was conducted at 3 sites in New Zealand, 1 site in Australia,
and 3 sites in Taiwan between 26 Aug 2015 and 27 Mar 2019. 6 patients
were recruited at one site (Dunedin, NZ) into the first cohort. Based on
interim safety and PK data, it was elected to recruit 34 further
patients at the same dose schedule.
In total, a total of 42 subjects were randomised, two participants
experienced AEs prior to receiving any study drug and were withdrawn,
and 40 subjects received study drug (37 received both OPE and IV
paclitaxel, 2 received OPE only, and 1 received IV paclitaxel only). Two
patients who received both treatments collected IV PK samples only up to
the end of infusion and hence were incomplete regarding PK assessment.
As such, 40 participants were considered for the safety analysis, and 35
were included for the PK analysis set (see fig 1 for further detail).