Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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).

Official Title

A Phase 1b Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone or Apalutamide in mCRPC (ARES: Androgen Receptor Eradication Study)

Keywords

Prostatic Neoplasms Prednisone Prednisolone Abiraterone Acetate EPI-7386 Prednisone or Prednisolone Apalutamide

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California San Francisco not yet accepting patients
    San Francisco California 94158-2549 United States
  • Cedars- Sinai Medical Center not yet accepting patients
    Los Angeles California 90048 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT05295927
Phase
Phase 1 Research Study
Study Type
Interventional
Participants
Expecting 82 study participants
Last Updated