Last updated on March 2018

Study to Evaluate CORT125134 in Combination With Nab-paclitaxel in Patients With Solid Tumors


Brief description of study

The purpose of this study is to assess the safety of the combination of CORT125134, a novel glucocorticoid receptor (GR) antagonist, and nab- paclitaxel in patients with solid tumors and to determine the preliminary efficacy of the combination of CORT125134 and nab-paclitaxel. The structure for the study is a single arm, non-randomized, open- label, multicenter trial with no control group.

Detailed Study Description

The study will consist of two segments to evaluate alternative dosing schedules of CORT125134 (Part 1) and a dose expansion which will occur once the development regimen for Segment I and Segment II has been determined (Part 2). Segment I will evaluate a continuous-dosing regimen and Segment II will evaluate an intermittent-dosing regimen. Enrollment in Segment I and Segment II will be mutually exclusive, and the two segments will enroll patients concurrently.

Segment I, Part 1: dose-escalation cohorts will be enrolled with approximately 62 patients to determine the maximum tolerated dose (MTD) and the development regimen for the continuous-dosing regimen. Treatment will be administered in 28-day cycles.

A continuous dosing cohort will be explored in patients with pancreatic cancer. Segment I, Part 2: Enrollment in Part 2 of the study (dose expansion) will occur once the development regimen for Segment I has been determined.

Segment II, Part 1: dose-escalation cohorts will be enrolled with approximately 24 patients to determine the MTD and the development regimen for the intermittent-dosing regimen. Treatment on Segment II Part I will be administered in 28-day cycles.

Segment II, Part 2: Enrollment in Part 2 of the study (dose expansion) will occur once the development regimen for Segment II has been determined.

Clinical Study Identifier: NCT02762981

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Northern Utah Associates

Ogden, UT United States
2.66miles
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Recruitment Status: Open


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