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Summary

Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

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 in patients with solid tumors. The structure for the study is a single arm, non-randomized, open-label, multicenter trial with no control group. The study will be conducted at approximately 8 sites with approximately 82 evaluable patients.

Official Title

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

Details

This study is conducted in two parts:

Part 1, a dose escalation phase, in which the Maximum Tolerated Dose (MTD) and Development Regimen will be determined in up to 42 patients with advanced or metastatic solid tumors. Treatment will be administered in 28-day cycles, with the exception of the first cycle, which will have a lead-in of 7 days dosing of CORT125134. CORT125134 is administered orally (PO) once daily for 28 days. Nab-paclitaxel will be administered intravenously (IV) on days 1, 8 and 15.

Part 2, a dose expansion phase in which a preliminary estimate of efficacy will be made in expansion groups of approximately 20 patients each.

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

Keywords

Solid Tumors Cellular Diagnosis, Ovarian Epithelial Cancer Breast Cancer CORT125134 nabpaclitaxel Triple-Negative Breast Cancer Ovarian Epithelial Cancer GR Antagonist Glucocorticoid Receptor Antagonist Paclitaxel Albumin-Bound 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 chemotherapeutics regimens in the advanced setting.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • For Part 2 Only: Platinum-resistant ovarian 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...

  • Systemic, inhaled or prescription strength topical corticosteroids within 21 days.

Locations

  • HonorHealth Research Institute accepting new patients
    Scottsdale, Arizona, 85258, United States
  • Northern Utah Associates accepting new patients
    Ogden, Utah, 84403, United States
  • University of Chicago Medical Center accepting new patients
    Chicago, Illinois, 60637, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Corcept Therapeutics
ID
NCT02762981
Phase
Phase 1/2
Lead Scientist
Pamela Munster
Study Type
Interventional
Last Updated
February 1, 2017
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