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NCT04986423 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by Zenith Epigenetics.

Recruiting
Registry status
Phase 2
Development phase
200
Enrollment target
20
Study locations

NCT04986423 is a Phase 2 study of Metastatic Castration-Resistant Prostate Cancer that is actively recruiting participants, run by Zenith Epigenetics. The registered enrollment target is 200 participants, roughly in line with the 195-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target. The trial reports 20 study locations across 17 states.

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The verdict

NCT04986423, a Phase 2 study of Metastatic Castration-Resistant Prostate Cancer, is actively recruiting participants, sponsored by Zenith Epigenetics.

RECRUITING
Registry status
Phase 2
Development phase
200 participants
Enrollment target
20
Study locations

Study Summary

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

Conditions Studied

Metastatic Castration-Resistant Prostate Cancer

Interventions

  • DRUG Enzalutamide
  • DRUG ZEN003694

Study Locations (20)

California

  • California Research Institute - Los Angeles
  • University of California, San Francisco - San Francisco
  • Innovative Clinical Research Institute - Whittier

Florida

  • D&H Cancer Research Center, LLC - Margate
  • BRCR Global - Plantation

Colorado

  • Colorado Urology - Lakewood

Louisiana

  • Hematology Oncology Clinic - Baton Rouge

Maryland

  • Maryland Oncology Hematology, P.A. - Columbia

Michigan

  • University of Michigan Rogel Cancer Center - Ann Arbor

New York

  • Weill Cornell Medical College - New York Presbyterian Hospital - New York

North Carolina

  • Messino Cancer Center - Asheville

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2021-09-08
Est. Completion 2026-06
Phase Phase 2

Sponsor

Zenith Epigenetics

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04986423

The ClinicalTrials.gov registry entry for NCT04986423 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 195-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target. The listed sponsor is Zenith Epigenetics, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Metastatic Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Enzalutamide is the first listed.

NCT04986423 reports 20 study locations spanning 17 distinct geographic areas - top geographies include California, Florida, Colorado.

Frequently Asked Questions

What is clinical trial NCT04986423 about?

NCT04986423 is a clinical study titled "ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer". 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. Th...

What is the current status of trial NCT04986423?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2021-09-08. Estimated completion is 2026-06.

What conditions does trial NCT04986423 study?

This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer.

What interventions are being tested in trial NCT04986423?

The interventions under investigation include: Enzalutamide (DRUG), ZEN003694 (DRUG).

Who is sponsoring clinical trial NCT04986423?

This trial is sponsored by Zenith Epigenetics, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04986423 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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