ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02762981
Recruitment Status : Recruiting
First Posted : May 5, 2016
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics

Brief 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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: CORT125134 with nab-paclitaxel Phase 1 Phase 2

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of CORT125134 in Combination With Nab-paclitaxel in Patients With Solid Tumors
Actual Study Start Date : May 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: CORT125134 with nab-paclitaxel

Part I - Dose Escalation:

Patients will be treated with CORT125134 in combination with nab-paclitaxel at escalating dose levels in either a Continuous-Dosing Regimen or an Intermittent-Dosing Regimen.

Part 2 - Dose Expansion:

Expansion cohorts in the Continuous-Dosing and Intermittent-Dosing Regimens will be enrolled to better characterize the antitumor activity in patients with specific tumor types and to better define the safety profile.

Drug: CORT125134 with nab-paclitaxel
CORT125134 is supplied as capsules for oral dosing. Nab-paclitaxel administered as an IV infusion.
Other Names:
  • Abraxane
  • Nanoparticle albumin-bound paclitaxel
  • Relacorilant




Primary Outcome Measures :
  1. Maximum Tolerated Dose of CORT125134 in Combination with nab-paclitaxel [ Time Frame: 24 months ]
    The Maximum Tolerated Dose and the development regimen of CORT125134 with nab-paclitaxel in patients with solid tumors as measured by the number of patients with dose-limiting toxicities


Secondary Outcome Measures :
  1. Number of Treatment-Related Adverse Events as Assessed by CTCAE version 4.0 for Patients with Solid Tumors Treated with CORT125134 in combination with nab-paclitaxel [ Time Frame: 28 days after last patient dosed ]
    To characterize the safety profile of the combination of CORT125134 and nab-paclitaxel.


Other Outcome Measures:
  1. Objective response rate [ORR], progression free survival [PFS], and overall survival [OS] patients with solid tumors [ Time Frame: 12 months from the enrollment of the final subject ]
    To characterize the preliminary anticancer activity (objective response rate [ORR], progression free survival [PFS], and overall survival [OS]) of the combination of CORT125134 and nab-paclitaxel in patients with solid tumors in a dose-finding phase and in patients with specific tumor types.

  2. Objective response rate [ORR], progression free survival [PFS], and overall survival [OS] in patients with GR-positive or GR negative solid tumors. [ Time Frame: 12 months from the enrollment of the final subject ]
    The preliminary anticancer activity (ORR, PFS, and OS) of the combination of CORT125134 and nab-paclitaxel in patients with GR-positive or GR negative solid tumors.

  3. Pharmacokinetics (PK) and exposure-response [ Time Frame: 2 weeks after last patient Cycle 1 Day 1 ]
    To characterize the pharmacokinetics (PK) and exposure-response of the combination of CORT125134 and nab paclitaxel in patients with solid tumors in a dose-finding phase and in patients with specific tumor types.

  4. Pharmacodynamics (PD) indicative of modulation of GR function, including hormonal changes and FKBP5 [ Time Frame: Baseline through end of treatment ]
    The pharmacodynamics (PD) of the combination of CORT125134 and nab-paclitaxel indicative of modulation of GR function, including hormonal changes and FKBP5.

  5. Molecular, cellular, and soluble markers in peripheral blood and/or tumor tissue [ Time Frame: Baseline through end of treatment ]
    To evaluate molecular, cellular, and soluble markers in peripheral blood and/or tumor tissue that may be relevant to the mechanism of action of or response/resistance to CORT125134.

  6. Pharmacogenomic (PG) markers [ Time Frame: Baseline ]
    To evaluate pharmacogenomic (PG) markers to assess genetic factors affecting drug metabolism and transporters.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02762981


Contacts
Contact: 550 Study Team corceptstudy550@corcept.com

Locations
United States, Arizona
HonorHealth Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94115
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
United States, Utah
Northern Utah Associates Completed
Ogden, Utah, United States, 84403
Sponsors and Collaborators
Corcept Therapeutics
Investigators
Study Director: Medical Monitor Corcept Therepeutics

Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT02762981     History of Changes
Other Study ID Numbers: CORT125134-550
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Corcept Therapeutics:
CORT125134
nabpaclitaxel
Triple-Negative Breast Cancer
Ovarian Epithelial Cancer
GR Antagonist
Glucocorticoid Receptor Antagonist
Pancreatic Cancer
Solid Tumors

Additional relevant MeSH terms:
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action