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A Pharmacokinetic/Pharmacodynamic Study of the Glucocorticoid Receptor Antagonist Mifepristone Combined with Enzalutamide in Castrate-Resistant Prostate Cancer

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University of Chicago Chicago United States

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This is a Clinical Exploration Award funding a clinical trial for patients with metastatic, castration resistant prostate cancer CRPC. For patients with metastatic CRPC, there are few established therapeutic options and the prognosis remains dire. The overarching goal of this award is to build on concept that under the selective pressure of androgen receptor AR targeted therapies, prostate cancer adapts. One way it adapts is by upregulating another hormone receptor, the glucocorticoid receptor GR, which may compensate for diminished AR activity. The clinical trial within this award is a phase III clinical trial of the GR antagonist mifepristone in combination with the FDA-approved AR antagonist enzalutamide. Within the phase I portion, the study will examine the pharmacokinetics and safety of the two drugs in combination. The phase II portion is a multi-site

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Technical Report,01 Dec 2013,30 Nov 2019



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Approved For Public Release;

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