The purpose of this study was to assess the safety of the combination of relacorilant
(CORT125134), a novel glucocorticoid receptor (GR) antagonist, and nab- paclitaxel in
participants with solid tumors and to determine the preliminary efficacy of the
combination of relacorilant and nab-paclitaxel. The structure for the study was a single
arm, non-randomized, open- label, multicenter trial with no control group.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02762981.
The study consisted of two segments to evaluate alternative dosing schedules of
relacorilant administered at escalating dose levels. Segment I was to evaluate a
continuous-dosing regimen and Segment II was to evaluate an intermittent-dosing regimen.
Enrollment in Segment I and Segment II were mutually exclusive, and the two segments
enrolled participants concurrently.
In Segment I continuous-dosing cohorts, participants received a single nab-paclitaxel
lead-in infusion on Day 1 of Week -2 before Cycle 1, and oral relacorilant lead-in
once-daily of Week -1 before Cycle 1. After the Data Review Committee review of data for
2 dose levels, the nab-paclitaxel lead-in was discontinued. The lead-in period was
followed by oral relacorilant administered continuously once daily, in combination with
nab-paclitaxel infusions on Days 1, 8, and 15 of each 28-day cycle. Segment 1 enrolled a
total of 64 participants.
In Segment II intermittent-dosing cohorts, participants received a single relacorilant
lead-in dose on Day -1 before Cycle 1, followed by oral relacorilant, administered
intermittently the day before, the day of, and the day after nab-paclitaxel infusions on
Days 1, 8, and 15 of each 28-day cycle. Segment II enrolled a total of 21 participants.
Lead OrganizationCorcept Therapeutics Inc
