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)

Summary

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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

82

Study ID:

NCT05295927

Recruitment Status:

Suspended

Sponsor:

Janssen Research & Development, LLC

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There are 4 Locations for this study

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Chesapeake Urology Research Associates
Towson Maryland, 21204, United States
GU Research Network
Omaha Nebraska, 68130, United States
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States
Prostate Cancer Centre
Calgary Alberta, T2V 1, Canada

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

82

Study ID:

NCT05295927

Recruitment Status:

Suspended

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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