Prostate Cancer Clinical Trial
A Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone, or Apalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC)
The purpose of this study is to determine safety, including dose limiting toxicities, and the recommended phase 2 dose (RP2D) of EPI-7386 in separate combinations with (a) abiraterone acetate plus prednisone or prednisolone (AAP) and (b) apalutamide (dose-finding) and to determine the antitumor activity of EPI-7386 in separate combinations with (a) AAP and (b) apalutamide (dose-expansion).
Histologically confirmed prostate adenocarcinoma
Must be able to continue Gonadotropin-releasing hormone agonist (GnRHa) during the study if not surgically castrate
Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1, or 2
Must be able to swallow oral medicines
Contraceptive use by men (and female partners of men enrolled in the study who are of childbearing potential or are pregnant) (birth control) use should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies
Willing and able to adhere to the prohibitions and restrictions specified in this protocol
Known central nervous system (CNS) metastases
Non-metastatic castration-resistant prostate cancer (CRPC) (biochemical or locoregional disease only) is excluded from trial participation
Evidence of predominant neuroendocrine/small cell carcinoma features in archival or baseline tumor biopsy specimen(s)
Symptomatic or impending spinal cord compression, except if participant has received definitive treatment and demonstrates evidence of clinically stable disease
Known disorder affecting gastrointestinal absorption
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There are 4 Locations for this study
Towson Maryland, 21204, United States
Omaha Nebraska, 68130, United States
Myrtle Beach South Carolina, 29572, United States
Calgary Alberta, T2V 1, Canada
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