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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

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

Surgical castration or continuous medical castration for ≥ 8 weeks prior to screening; serum testosterone < 50 ng/dL confirmed within 4 weeks of first administration of study drug

Must not have

Have received prior systemic anti-cancer therapy within 2 weeks or five half-lives, whichever is shorter, prior to the first administration of study drug

Failure to recover to Grade 1 or lower toxicity related to prior systemic therapy (excluding alopecia and neuropathy) prior to study entry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization up to 30 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had cancer treatment within the last 2 weeks or five half-lives before starting the study drug.

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I still have side effects from previous treatments, except for hair loss and nerve issues.

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I have not had radiation therapy in the last 2 weeks.

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I have had brain metastases, seizures, or conditions that could lead to seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization up to 30 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cohort A: Radiographic progression-free survival (rPFS) by BICR

Secondary study objectives

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

58%

Visual impairment

52%

Nausea

42%

Fatigue

32%

Decreased appetite

32%

Dysgeusia

19%

Thrombocytopenia

16%

Diarrhea

10%

Weight decreased

10%

Photosensitivity reaction

10%

Constipation

10%

Photopsia

10%

Taste disorder

10%

Vomiting

10%

Dizziness

10%

Blood creatinine increased

Intervertebral discitis

Acute kidney injury

Musculoskeletal pain

Myocardial ischaemia

Spinal cord compression

Rash maculopapular

100%

80%

60%

40%

20%

Study treatment Arm

DE/DC A+B 96 mg ZEN003694 + Enzalutamide

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 A+B 120 mg ZEN003694 + Enzalutamide

DE A+B 144 mg ZEN003694 + Enzalutamide

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Group III: 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.

Group IV: Cohort A - EnzalutamideActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ZEN003694

2016

Completed Phase 2

~120

Enzalutamide

2014

Completed Phase 4