ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Zenith Epigenetics
Study ID
NCT04986423
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • ZEN003694 — DRUG
    72 mg PO QD
  • Enzalutamide — DRUG
    160 mg PO QD

Study Details

This is an open-label, randomized, Phase 2b study of ZEN003694 in combination with enzalutamide vs. enzalutamide monotherapy in patients with mCRPC who have progressed on prior abiraterone by PCWG3 criteria. Disease must have progressed on only abiraterone by PCWG3 criteria prior to study entry. The patient population will be separated into two cohorts: Cohort A: Patients with poor response to prior abiraterone defined as: * Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: \< 12 months duration on abiraterone or failure to achieve PSA nadir of 0.2 ng/mL while taking abiraterone, or; * Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: \< 6 months duration on abiraterone or failure to achieve PSA50 response while on abiraterone Cohort B: Patients with response to prior abiraterone, defined as: * Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: ≥ 12 months duration on abiraterone and nadir PSA \< 0.2 ng/mL, or; * Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: ≥ 6 months duration on abiraterone and confirmed PSA50 response

Key Dates

Start date
Sep 8, 2021
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A - ZEN003694 + Enzalutamide
    Patients will be administered enzalutamide (160 mg) orally once daily for 21 days prior to the initiation of the combination therapy (Lead-in) to reach steady state concentration (Css) prior to Cycle 1. After the Lead-in, ZEN003694 (72 mg) will be administered orally one daily in combination with daily enzalutamide for 28-day cycles.
  • Active Comparator: Cohort A - Enzalutamide
    Patients will be administered enzalutamide (160 mg) orally once daily for 21 days prior to Cycle 1 Day 1 (Lead-in). After the Lead-in, patients will be administered enzalutamide 160 mg orally once daily for 28-day cycles. Active control patients will have the option to cross-over to treatment with ZEN003694 in combination with enzalutamide upon confirmed radiographic progression by PCWG3 criteria by independent central review.
  • Experimental: Cohort B - ZEN003694 + Enzalutamide
    Patients will be administered enzalutamide (160 mg) orally once daily for 21 days prior to the initiation of the combination therapy (Lead-in) to reach steady state concentration (Css) prior to Cycle 1. After the Lead-in, ZEN003694 (72 mg) will be administered orally one daily in combination with daily enzalutamide for 28-day cycles.
  • Active Comparator: Cohort B - Enzalutamide
    Patients will be administered enzalutamide (160 mg) orally once daily for 21 days prior to Cycle 1 Day 1 (Lead-in). After the Lead-in, patients will be administered enzalutamide 160 mg orally once daily for 28-day cycles. Active control patients will have the option to cross-over to treatment with ZEN003694 in combination with enzalutamide upon confirmed radiographic progression by PCWG3 criteria by independent central review.

Primary Outcome Measure

Cohort A: Radiographic progression-free survival (rPFS) by BICR [ Time Frame: Randomization up to 30 months ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
California Research InstituteLos AngelesCalifornia90027-
University of California, San FranciscoSan FranciscoCalifornia94158-
Innovative Clinical Research InstituteWhittierCalifornia90603-
Colorado UrologyLakewoodColorado80228-
D&H Cancer Research Center, LLCMargateFlorida33063-
BRCR GlobalPlantationFlorida33322-
Hematology Oncology ClinicBaton RougeLouisiana70809-
Maryland Oncology Hematology, P.A.ColumbiaMaryland21044-
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109-
Weill Cornell Medical College - New York Presbyterian HospitalNew YorkNew York10065-
Messino Cancer CenterAshevilleNorth Carolina28806-
Northwest Cancer Specialists, P.C.PortlandOregon97223-
Urology Associates, P.C.NashvilleTennessee37209-
Texas Oncology - Central SouthAustinTexas78731-
Virginia Cancer SpecialistsFairfaxVirginia22031-
Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in Los Angeles, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
California Research Institute· Los Angeles, CAUniversity of California, San Francisco· San Francisco, CAInnovative Clinical Research Institute· Whittier, CAColorado Urology· Lakewood, COD&H Cancer Research Center, LLC· Margate, FLBRCR Global· Plantation, FL

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