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
  • A Multicenter, Open-Label, Parallel, Phase 1b/2a Study of PLX2853 in Combination with Abiraterone Acetate and Prednisone and Phase 1b/2a Study of PLX2853 in Combination with Olaparib in Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC)

    Cancer Categories
    • Genitourinary (GU)
    Karmanos Trial ID
    • 2020-128
    NCT ID
    • NCT04556617
    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:

    PLX2853 + Abiraterone Acetate + Prednisone Combination

    Phase 1b:
    Primary Objectives
    • To evaluate the safety and tolerability of PLX2853 + abiraterone acetate + prednisone including dose limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) in subjects with mCRPC who develop disease progression while currently receiving initial treatment with abiraterone acetate and prednisone

    Secondary Objectives
    • To characterize the PK of PLX2853 and abiraterone and efficacy of PLX2853 combined with abiraterone acetate + prednisone in subjects with mCRPC who develop disease progression while currently receiving initial treatment with abiraterone acetate and prednisone

    Phase 2a:
    Primary Objectives
    • To evaluate the efficacy of PLX2853 + abiraterone acetate + prednisone at the RP2D in subjects with mCRPC who develop disease progression while currently receiving initial treatment with abiraterone acetate and prednisone

    Secondary Objectives
    • To further characterize the safety and PK of PLX2853 and abiraterone when PLX2853 is combined with abiraterone acetate + prednisone in subjects with mCRPC who develop disease progression while currently receiving initial treatment with abiraterone acetate and prednisone

    PLX2853 + Olaparib Combination

    Phase 1b:
    Primary Objectives
    • To evaluate the safety and tolerability of PLX2853 + olaparib including dose limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) in subjects with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated mCRPC who have progressed following prior treatment with abiraterone acetate and prednisone or with enzalutamide

    Secondary Objectives
    • To characterize the PK of PLX2853 and olaparib and efficacy of PLX2853 combined with olaparib in subjects with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated mCRPC who have progressed following prior treatment with abiraterone acetate and prednisone or with enzalutamide

    Phase 2a:
    Primary Objective
    • To evaluate the efficacy of PLX2853 + olaparib at the RP2D in subjects with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated mCRPC who have progressed following prior treatment with abiraterone acetate and prednisone or with enzalutamide

    Secondary Objectives
    • To further characterize the safety and PK of PLX2853 and olaparib when PLX2853 is combined with olaparib in subjects with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated mCRPC who have progressed following prior treatment with abiraterone acetate and prednisone or with enzalutamide

  • 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