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ZEN003694 Continuation for Prostate Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Zenith Epigenetics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is continuing for patients who experienced clinical benefit while enrolled in a previous trial for the same drug.

Who is the study for?

This trial is for prostate cancer patients who saw benefits from a previous ZEN003694 study. They should be in good physical condition (ECOG status of 0 or 1) and have handled the drug well before. Participants must start this follow-up within two weeks after their last dose in the original trial, unless given more time by the sponsor.Check my eligibility

What is being tested?

The study continues treatment with ZEN003694 for those who benefited previously, alongside Enzalutamide, an established prostate cancer medication. The aim is to see if ongoing treatment maintains or improves patient outcomes.See study design

What are the potential side effects?

While specific side effects are not listed here, participants must have tolerated ZEN003694 well during prior trials to join this continuation protocol. Side effects may include those experienced earlier plus any associated with Enzalutamide.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE)

Secondary outcome measures

Evaluate Overall survival (OS): Time from date of first dose of ZEN003694 in the parent protocol or randomization to the date of death from any cause

Evaluate radiographic response rate by RECIST 1.1 criteria

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%

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

1Treatment groups

Experimental Treatment

Group I: Experimental: ZEN003694 in Combination with EnzalutamideExperimental Treatment2 Interventions

Patients who have completed participation in their original ZEN003694-002 protocol and have clinical benefit as determined by the investigator may continue to receive treatment with ZEN003694 in combination with enzalutamide

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enzalutamide

2014

Completed Phase 4

~2760

ZEN003694

2016

Completed Phase 2

~120

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Zenith EpigeneticsLead Sponsor

9 Previous Clinical Trials

572 Total Patients Enrolled

Media Library

ZEN003694 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04145375 — Phase 1 & 2

Prostate Cancer Research Study Groups: Experimental: ZEN003694 in Combination with Enzalutamide

Prostate Cancer Clinical Trial 2023: ZEN003694 Highlights & Side Effects. Trial Name: NCT04145375 — Phase 1 & 2

ZEN003694 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04145375 — Phase 1 & 2

Frequently Asked Questions

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

Are there any precedents for the ZEN003694 clinical trial?

"ZEN003694 was first studied in 2005 at Rosemere Cancer Centre. So far, there have been 86 completed clinical trials and 103 active studies. Many of the active studies are being conducted in San Francisco, California."

Answered by AI

How many people are being accepted into this experiment?

"The study was last updated over two months ago and is not currently looking for patients. If you're interested in other research trials, there are 9 mcrpc studies and 103 ZEN003694 studies that are still enrolling participants."

Answered by AI

Are there any current openings for this type of medical treatment?

"This particular research study is not enrolling patients at the moment. The clinical trial was initially posted on November 12th, 2019 and was updated most recently on May 31st, 2022. If you are seeking other studies, there are 9 mcrpc trials and 103 ZEN003694 studies that are currently looking for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol

2019. "Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04145375.