Oral EPI-7386 in Patients with Castration-Resistant Prostate Cancer

Part of paid clinical trials in Port Saint Lucie, Florida.

Sponsor
ESSA Pharmaceuticals
Study ID
NCT04421222
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • EPI-7386 (QD) — DRUG
    Once daily oral dose of EPI-7386
  • EPI-7386 (BID) — DRUG
    Twice daily oral dose of EPI-7386
  • Abiraterone acetate — DRUG
    Once daily dose of abiraterone acetate
  • Apalutamide — DRUG
    Once daily dose of apalutamide

Study Details

This is a phase I, clinical research study of EPI-7386, an investigational drug being studied as a treatment for patients with prostate cancer. All patients in the study will receive EPI-7386. Since this is the first study of EPI-7386 in humans, there is no information about how it affects people or what dose should be used. Therefore, the main purpose of this study is to assess the safety (side effects) of EPI-7386 and to find a dose that can be given without unacceptable side effects. There are other important things that will be evaluated during the study: * How the amount of EPI-7386 in the blood changes over time. * The effect of EPI-7386 on prostate cancer. * The effect of EPI-7386 on certain substances in the body. * The possibility that EPI-7386 can interact with other drugs. The study will be conducted in 2 parts: * Part A: To evaluate the safety and tolerability of EPI-7386 as a single agent via 2 Phases: * Phase 1a: Dose Escalation (mCRPC) * Phase 1b: Dose Expansion (mCRPC) * Part B: To evaluate 2 parallel enrolling cohorts (Cohort 1 and Cohort 2) of EPI-7386 in combination of apalutamide acetate + prednisone (AAP) or apalutamide (APA): * Cohort 1: Combination with AAP in mHSPC or mCRPC patients * Cohort 2: Will evaluate the anti-tumor activity of EPI-7386 for a limited window of time (12 weeks EPI-7386 monotherapy prior to the start of combination therapy with APA) in nmCRPC patients unperturbed by previous 2nd generation anti-androgen therapies or chemotheraphy.

Key Dates

Start date
Jun 23, 2020
Status verified
Feb 2025
Primary completion
Oct 31, 2024
Completion
Dec 3, 2024

Study Design

Enrollment
71 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A/Phase 1a: Cohort 1 (Completed)
    200 mg EPI-7386
  • Experimental: Part A/Phase 1a: Cohort 2 (Completed)
    400 mg EPI-7386
  • Experimental: Part A/Phase 1a: Cohort 3 (Completed)
    600 mg EPI-7386
  • Experimental: Part A/Phase 1a: Cohort 4 (Completed)
    800 mg EPI-7386
  • Experimental: Part A/Phase 1a: Cohort 5 (Completed)
    1000 mg EPI-7386
  • Experimental: Part A/Phase 1a: Cohort 6 (Completed)
    800 mg EPI-7386
  • Experimental: Part A/Phase 1a: Cohort 7 (Completed)
    1200 mg EPI-7386
  • Experimental: Part A/Phase 1b: Cohort 1 (Completed)
    600 mg EPI-7386 BID
  • Experimental: Part A/Phase 1b: Cohort 2
    600 mg EPI-7386 QD
  • Experimental: Part B/Cohort 1a
    600 mg EPI-7386 + 1000 mg Abiraterone Acetate + Prednisone
  • Experimental: Part B/Cohort 1b
    800 mg EPI-7386 + 1000 mg Abiraterone Acetate + Prednisone
  • Experimental: Part B/Cohort 1c
    1200 mg EPI-7386 + 1000 mg Abiraterone Acetate + Prednisone
  • Experimental: Part B/Cohort 2a
    600 mg EPI-7386 monotherapy for 12 weeks then 600 mg EPI-7386 + 240 mg Apalutamide
  • Experimental: Part B/Cohort 2b
    800 mg EPI-7386 monotherapy for 12 weeks then 800 mg EPI-7386 + 240 mg Apalutamide
  • Experimental: Part B/Cohort 2c
    1200 mg EPI-7386 monotherapy for 12 weeks then 1200 mg EPI-7386 + 240 mg Apalutamide

Primary Outcome Measure

The primary safety variable for Part A/Phase 1a of the study is the incidence of protocol-defined DLT during the DLT assessment period (first 28 days of dosing). [ Time Frame: 2 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
Hematology Oncology Associates of the Treasure CoastPort Saint LucieFlorida34952-
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-
Massachusetts General HospitalBostonMassachusetts02215-
Washington University School of Medicine in St. LouisSt LouisMissouri63110-
Comprehensive Cancer Center of NV Las VegasLas VegasNevada89169-
Great Lakes Cancer CenterBuffaloNew York14203-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in Port Saint Lucie, FL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Hematology Oncology Associates of the Treasure Coast· Port Saint Lucie, FLWinship Cancer Institute of Emory University· Atlanta, GAMassachusetts General Hospital· Boston, MAWashington University School of Medicine in St. Louis· St Louis, MOComprehensive Cancer Center of NV Las Vegas· Las Vegas, NVGreat Lakes Cancer Center· Buffalo, NY

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