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Androgen Receptor Inhibitor

ZEN003694 + Enzalutamide for Prostate Cancer

Phase 2
Recruiting
Research Sponsored by Zenith Epigenetics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who are not candidates for chemotherapy in the opinion of the investigator or patients who decline chemotherapy
Cohort A only - Patient must meet definition of poor responder to abiraterone by one of the following: 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 Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: < 6 months duration on abiraterone or failure to achieve a PSA50 response
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization up to 30 months
Awards & highlights

Study Summary

This trial is testing a new drug, ZEN003694, to see if it is more effective than the current standard of care, enzalutamide, in patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed on prior abiraterone. Patients will be randomized to receive either ZEN003694 in combination with enzalutamide or enzalutamide monotherapy. The primary endpoint is radiographic progression-free survival (rPFS) by PCWG3 criteria.

Who is the study for?
Men over 18 with metastatic, castration-resistant prostate cancer that worsened after abiraterone treatment. They must have low testosterone levels and not be candidates for chemotherapy or refuse it. There are two groups: one had a poor response to abiraterone, the other had a better response.Check my eligibility
What is being tested?
This study is testing ZEN003694 combined with enzalutamide against enzalutamide alone in men whose prostate cancer has progressed despite previous treatment with abiraterone. It's an open-label trial where patients know which treatment they're getting.See study design
What are the potential side effects?
Possible side effects of ZEN003694 and enzalutamide include fatigue, digestive issues, skin reactions, hormonal changes like hot flashes, high blood pressure, and potential risks to heart health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I cannot or do not want to undergo chemotherapy.
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I have prostate cancer and did not respond well to abiraterone treatment.
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I have been on hormone therapy for prostate cancer for at least 8 weeks, and my testosterone levels are low.
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My cancer has worsened despite being treated with abiraterone.
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I am a man aged 18 or older.
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My prostate cancer has spread and is not responding to hormone therapy.
Select...
I responded well to abiraterone for my prostate cancer and can care for myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization up to 30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization up to 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohort A: Radiographic progression-free survival (rPFS) by BICR
Secondary outcome measures
Cohort A + B: Overall survival (OS)
Cohort A + B: PSA50 response rate
Cohort A + B: Progression-free survival (PFS) by investigator assessment
+12 more

Side effects data

From 2019 Phase 1 & 2 trial • 75 Patients • NCT02711956
75%
Visual impairment
25%
Haematuria
25%
Fatigue
25%
Weight decreased
25%
Enterococcal bacteraemia
25%
Pathological fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
DE A+B 36 mg ZEN003694 + Enzalutamide
DE/DC A+B 48 mg ZEN003694 + Enzalutamide
DE A+B 60 mg ZEN003694 + Enzalutamide
DE A+B 72 mg ZEN003694 + Enzalutamide
DE/DC A+B 96 mg ZEN003694 + Enzalutamide
DE A+B 120 mg ZEN003694 + Enzalutamide
DE A+B 144 mg ZEN003694 + Enzalutamide

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Cohort B - ZEN003694 + EnzalutamideExperimental Treatment2 Interventions
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.
Group II: Cohort A - ZEN003694 + EnzalutamideExperimental Treatment2 Interventions
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.
Group III: Cohort A - EnzalutamideActive Control1 Intervention
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.
Group IV: Cohort B - EnzalutamideActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ZEN003694
2016
Completed Phase 2
~120
Enzalutamide
2014
Completed Phase 4
~2760

Find a Location

Who is running the clinical trial?

Newsoara Biopharma Co., Ltd.Industry Sponsor
6 Previous Clinical Trials
776 Total Patients Enrolled
Zenith EpigeneticsLead Sponsor
9 Previous Clinical Trials
412 Total Patients Enrolled
Astellas Pharma IncIndustry Sponsor
689 Previous Clinical Trials
219,839 Total Patients Enrolled
36 Trials studying Prostate Cancer
8,642 Patients Enrolled for Prostate Cancer

Media Library

Enzalutamide (Androgen Receptor Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04986423 — Phase 2
Prostate Cancer Research Study Groups: Cohort A - ZEN003694 + Enzalutamide, Cohort A - Enzalutamide, Cohort B - ZEN003694 + Enzalutamide, Cohort B - Enzalutamide
Prostate Cancer Clinical Trial 2023: Enzalutamide Highlights & Side Effects. Trial Name: NCT04986423 — Phase 2
Enzalutamide (Androgen Receptor Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04986423 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What verdict has the Food and Drug Administration reached regarding ZEN003694?

"Our team at Power assigned a score of 2 to ZEN003694 due to the lack of efficacy data, though there is some evidence confirming its safety."

Answered by AI

Are there any precedents for using ZEN003694 in clinical trials?

"The first medical trial for ZEN003694 was initiated in 2005 at Rosemere Cancer Centre of Royal Preston Hospital. As of now, a total of 86 trials have been fully completed, with 98 more on-going studies occurring primarily in Lakewood, Colorado."

Answered by AI

How many medical institutions are conducting this trial?

"The trial is currently operational in 8 centres, spanning Lakewood, New york and Asheville. It's important to pick the site closest to you so that travel obligations are minimized if participation is chosen."

Answered by AI

What is the upper bound on participants for this clinical study?

"To move forward with the study, Zenith Epigenetics requires 200 qualified patients. The sponsor will be managing this trial from multiple locations such as Colorado Urology in Lakewood and Weill Cornell Medical College - New york Presbyterian Hospital in Manhattan."

Answered by AI

Does this research endeavor accept additional participants?

"That is accurate. The information compiled on clinicaltrials.gov shows that this medical trial, which was first created on the 8th of September 2021, is currently enrolling participants. 200 test subjects will be accepted at a total of 8 different sites."

Answered by AI
~57 spots leftby Mar 2025