Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • Phase 1/2a Dose-Escalation and Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CORT125281 with Enzalutamide in Patients with Metastatic Castration-Resistant Prostate Cancer

    Cancer Categories
    • Genitourinary (GU)
    Karmanos Trial ID
    • 2018-124
    NCT ID
    • NCT03437941
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase I
    Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
    • Phase I/II
    Principal Investigator

    Objective:

    Primary Objective:
    • Determine the maximum tolerated dose (MTD) and/or biologically active doses of CORT125281 in combination with enzalutamide to identify the recommended dose (RD) for Phase 2 studies
    Secondary Objectives:
    • Evaluate the safety and tolerability of CORT125281 in combination with enzalutamide
    • Characterize the preliminary efficacy of CORT125281 in combination with enzalutamide by determining the objective response rate (ORR), proportion of patients with a reduction in prostate-specific antigen (PSA) level by >50%, time to a symptomatic skeletal event (SSE), radiographic progression-free survival (rPFS) at 4, 6, and 12 months, duration of response, and overall survival
    • Assess time to PSA progression and clinical progression, including the proportion of patients progression-free at 4, 6, and 12 months
    • Determine the pharmacokinetic (PK) profile of CORT125281 and enzalutamide, when co-administered
    • Determine the effect of food on the PK of CORT125281
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Phone: 800-527-6266

    Karmanos Cancer Institute at Lawrence and Idell Weisberg Cancer Treatment Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266