A Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone, or Apalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC)

Part of paid clinical trials in Towson, Maryland.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05295927
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EPI-7386 — DRUG
    EPI-7386 will be administered orally once daily.
  • Abiraterone Acetate — DRUG
    Abiraterone Acetate will be administered orally once daily.
  • Prednisone or Prednisolone — DRUG
    Prednisone or Prednisolone will be administered orally twice daily.
  • Apalutamide — DRUG
    Apalutamide will be administered orally once daily.

Study Details

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).

Key Dates

Start date
Mar 23, 2022
Status verified
Jan 2025
Primary completion
Sep 30, 2022
Completion
Sep 30, 2022

Study Design

Enrollment
3 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A: EPI-7386 + Abiraterone Acetate Plus Prednisone (AAP)
    Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive EPI-7386 + AAP to determine the recommended phase 2 dose (RP2D) dose of EPI-7386 in combination with AAP in dose finding portion of the study. In dose expansion portion of the study, participants will receive EPI-7386 RP2D in combination with AAP.
  • Experimental: Group B: EPI-3786 + Apalutamide
    Participants with mCRPC will receive EPI-7386 + apalutamide to determine RP2D dose of EPI-7386 in combination with apalutamide in dose finding portion of the study. In dose expansion portion of the study, participants will receive EPI-7386 RP2D in combination with apalutamide.

Primary Outcome Measure

Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 3 Years 3 Months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Chesapeake Urology Research AssociatesTowsonMaryland21204-
GU Research NetworkOmahaNebraska68130-
Carolina Urologic Research CenterMyrtle BeachSouth Carolina29572-

Find similar trials in Towson, MD

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Chesapeake Urology Research Associates· Towson, MDGU Research Network· Omaha, NECarolina Urologic Research Center· Myrtle Beach, SC

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