A Phase 1/2 Study of EPI-7386 in Combination with Enzalutamide Compared with Enzalutamide Alone in Subjects with Metastatic Castration-Resistant Prostate Cancer
Researchers think the study drug, EPI-7386, may be an effective treatment for metastatic castration-resistant prostate cancer (mCRPC) because the drug works by interfering with the function of the male hormone system that leads to the growth of prostate cancer. Enzalutamide is an androgen receptor inhibitor that works by blocking the action of male hormones (androgens) like testosterone to slow down the growth of prostate cancer. Enzalutamide is approved by the Food & Drug Administration (FDA) and is commonly used as a standard of care option for men with advanced or metastatic castration-resistant prostate cancer. Since EPI-7386 and enzalutamide have not been combined together in humans, we are doing this study to find out whether EPI-7386, in combination with a fixed dose of enzalutamide, compared to standard of care enzalutamide alone, is a safe and effective treatment for men who have mCRPC. Study will be done at Spindrift Clinic location.
This is a Phase 1/2 study of EPI-7386 orally administered in combination with enzalutamide in subjects with mCRPC. The main objectives of Phase 1 of this study will be to evaluate potential drug-drug interactions (DDI) between EPI-7386 and enzalutamide. The main objective of the Phase 2 is to evaluate the antitumor activity of EPI7386 in combination with a fied dose of enzaluta
1) Males aged 18 years or older
2) Histologically, pathologically, or cytologically confirmed prostate adenocarcinoma
3) Presence of metastatic disease at study entry
4) Naïve to second generation anti-androgens
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