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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:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Study to Evaluate CORT125134 in Combination With <span class="go-doc-concept go-doc-intervention">Nab-paclitaxel</span> in Patients With Solid Tumors

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

    NCT ID: NCT02762981

    ORG ID: CORT125134-550

    Trial Conditions

    Solid Tumors

    Cellular Diagnosis, Ovarian Epithelial Cancer

    Breast Cancer

    Trial Interventions

    Drug Synonyms Arms
    CORT125134 with nab-paclitaxel Abraxane, nanoparticle albumin-bound paclitaxel CORT125134 with nab-paclitaxel

    Trial 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 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.

    Detailed Description

    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) with food 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.

    Trial Arms

    Name Type Description Interventions
    CORT125134 with nab-paclitaxel Experimental Single Arm, Two Parts: Part 1: Dose Escalation Phase to determine Maximum Tolerated Dose in up to 42 patients for treatment regimen of CORT125134 with nab-paclitaxel. Part 2: Dose Expansion Phase at the Maximum Tolerated Dose in 20 patients per cohort of treatment regimen of CORT125134 with nab-paclitaxel. 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 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.

    Exclusion Criteria:

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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Maximum Tolerated Dose of CORT125134 in Combination with nab-paclitaxel

    Secondary Outcome Measures

    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

    Trial Keywords

    CORT125134

    nabpaclitaxel

    Triple-Negative Breast Cancer

    Ovarian Epithelial Cancer

    GR Antagonist

    Glucocorticoid Receptor Antagonist