NCT02762981

Study to Evaluate Relacorilant (CORT125134) in Combination With Nab-paclitaxel in Participants With Solid Tumors

Phase 1/2 Study of CORT125134 in Combination With Nab-paclitaxel in Patients With Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	Relacorilant with nab-paclitaxel	Relacorilant is supplied as capsules for oral dosing. Nab-paclitaxel administered as an IV infusion.

Timeline

• Start date: 2016-05-23
• Primary completion: 2020-05-12
• Completion: 2020-09-12
• First posted: 2016-05-05
• Last updated: 2022-12-06
• Results posted: 2022-12-06

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study