Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Pamela Munster

Description

Summary

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.

Official Title

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

Details

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.

Keywords

Solid Tumors CORT125134 nabpaclitaxel Triple-Negative Breast Cancer Ovarian Epithelial Cancer GR Antagonist Glucocorticoid Receptor Antagonist Pancreatic Cancer Paclitaxel Albumin-Bound Paclitaxel CORT125134 with nab-paclitaxel

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patients with advanced or metastatic solid tumors who have disease progression after treatment with available therapies and for whom nab-paclitaxel treatment is appropriate.
  • Measurable or evaluable disease.
  • Up to 3 prior cytotoxic chemotherapeutics regimens or myelosuppressive therapies in the advanced setting.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • For Part 2 Only: Platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer, or Triple Negative Breast Cancer with measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in at least 1 lesion, that in the opinion of the Investigator is appropriate to treat with nab-paclitaxel.

You CAN'T join if...

  • Any major surgery within 4 weeks prior to the first dose of study drug.
  • Some protocol specified treatments prior to the first dose of study drug.

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94115 United States
  • HonorHealth Research Institute accepting new patients
    Scottsdale Arizona 85258 United States

Lead Scientist

  • Pamela Munster
    Professor, Medicine. Authored (or co-authored) 92 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Corcept Therapeutics
ID
NCT02762981
Phase
Phase 1/2
Study Type
Interventional
Last Updated