Clinical Trials /

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

NCT02762981

Description:

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.

Related Conditions:
  • Breast Carcinoma
  • Malignant Solid Tumor
  • Ovarian Carcinoma
Recruiting Status:

Completed

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT02762981

Trial Eligibility

Document

Title

  • Brief Title: Study to Evaluate CORT125134 in Combination With Nab-paclitaxel in Patients With Solid Tumors
  • Official Title: Phase 1/2 Study of CORT125134 in Combination With Nab-paclitaxel in Patients With Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: CORT125134-550
  • NCT ID: NCT02762981

Conditions

  • Solid Tumors

Interventions

DrugSynonymsArms
CORT125134 with nab-paclitaxelAbraxane, Nanoparticle albumin-bound paclitaxel, RelacorilantCORT125134 with nab-paclitaxel

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
CORT125134 with nab-paclitaxelExperimentalPart 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.
  • CORT125134 with nab-paclitaxel

Eligibility 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.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose of CORT125134 in Combination with nab-paclitaxel
Time Frame:24 months
Safety Issue:
Description: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

Measure: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
Safety Issue:
Description:To characterize the safety profile of the combination of CORT125134 and nab-paclitaxel.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Corcept Therapeutics

Trial Keywords

  • CORT125134
  • nabpaclitaxel
  • Triple-Negative Breast Cancer
  • Ovarian Epithelial Cancer
  • GR Antagonist
  • Glucocorticoid Receptor Antagonist
  • Pancreatic Cancer
  • Solid Tumors

Last Updated

May 18, 2021