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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02762981
Recruitment Status : Active, not recruiting
First Posted : May 5, 2016
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics

Tracking Information
First Submitted Date  ICMJE April 11, 2016
First Posted Date  ICMJE May 5, 2016
Last Update Posted Date August 28, 2019
Actual Study Start Date  ICMJE May 2016
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2016)
Maximum Tolerated Dose of CORT125134 in Combination with nab-paclitaxel [ Time Frame: 10 months ]
The Maximum Tolerated Dose of CORT125134 with nab-paclitaxel in patients with solid tumors as measured by the number of patients with dose-limiting toxicities
Change History Complete list of historical versions of study NCT02762981 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2018)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2016)
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: 24 months ]
The safety profile of CORT125134 with nab-paclitaxel in patients with solid tumors in a dose finding phase and in patients with specific tumor types treated with the Maximum Tolerated Dose
Current Other Pre-specified Outcome Measures
 (submitted: March 13, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Pharmacogenomic (PG) markers [ Time Frame: Baseline ]
    To evaluate pharmacogenomic (PG) markers to assess genetic factors affecting drug metabolism and transporters.
Original Other Pre-specified Outcome Measures
 (submitted: May 3, 2016)
Preliminary anticancer activity (objective response rate [ORR%]) of CORT125134 with nab-paclitaxel [ Time Frame: 12 months ]
ORR% as defined by RECIST v1.1 in cohorts of patient treated with the Maximum Tolerated Dose
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate CORT125134 in Combination With Nab-paclitaxel in Patients With Solid Tumors
Official Title  ICMJE Phase 1/2 Study of CORT125134 in Combination With Nab-paclitaxel in Patients With Solid Tumors
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumors
Intervention  ICMJE 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
Study Arms  ICMJE 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.

Intervention: Drug: CORT125134 with nab-paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 13, 2018)
146
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2016)
82
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02762981
Other Study ID Numbers  ICMJE CORT125134-550
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Corcept Therapeutics
Study Sponsor  ICMJE Corcept Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Corcept Therepeutics
PRS Account Corcept Therapeutics
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP