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 Ib/II Single-Arm Multi-Center Study of IONIS-AR-2.5Rx, a Next Generation Androgen Receptor Antisense Oligonucleotide, in combination with Enzalutamide in Metastatic Castration Resistant Prostate Cancer

    Cancer Categories
    • Genitourinary (GU)
    Karmanos Trial ID
    • 2020-093
    NCT ID
    • NCT03300505
    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
    Phase Ib: To determine the maximum tolerated dose (MTD) of IONIS-AR-2.5Rx in combination with enzalutamide.
    Phase II: To estimate the anti-tumor efficacy of IONIS-AR-2.5Rx in combination with enzalutamide as measured by PSA response rate in patients with metastatic castration resistant prostate cancer.

    Secondary Objectives
    1. To estimate secondary measures efficacy of IONIS-AR-2.5Rx in combination with enzalutamide in CRPC subjects including radiographic progression-free survival (rPFS) by PCWG3-modified RECIST 1, 30% PSA reduction proportion, PSA progression-free survival, Duration of Therapy (DOT), Duration of Response (DOR), PFS and OS.
    2. To determine the safety and toxicity of IONIS-AR-5Rx, the Androgen Receptor AntiSense Oligonucleotide (AR ASO) in patients with metastatic castration resistant prostate cancer.
  • 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