40 Participants Needed

ZEN003694 Continuation for Prostate Cancer

Recruiting at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Zenith Epigenetics
Must be taking: ZEN003694
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial continues to provide ZEN003694 to patients who have already shown improvement from it in an earlier study. The medication helps by changing certain body functions related to their condition. Patients must have been part of an earlier study with this medication to join this continuation trial.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications, but it does not allow changes to your current treatment for the cancer being studied.

Is ZEN003694 (Enzalutamide) safe for humans?

Enzalutamide, also known as ZEN003694, has been studied in various trials for prostate cancer, and while it has shown benefits in survival and quality of life, patient-reported outcomes suggest that it is generally safe for use in humans.12345

What data supports the effectiveness of the drug enzalutamide for prostate cancer?

Research shows that enzalutamide helps men with prostate cancer live longer, especially those whose cancer has spread or who have already had chemotherapy. It also delays the spread of cancer in patients whose cancer hasn't yet spread.15678

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

ECOG performance status of 0 or 1
Protocol-defined completion in a parent ZEN003694 trial
Patient has clinical benefit as determined by the investigator at the time of entry to the continuation protocol
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Exclusion Criteria

Concurrent participation in another clinical investigational treatment trial
Require addition of or change to a new concomitant therapy to adequately treat the malignancy under study
Discontinued ZEN003694 or withdrew consent to participate in original Zenith Epigenetics-sponsored ZEN003694 study
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Continuation Treatment

Participants continue to receive ZEN003694 in combination with enzalutamide after completing the parent protocol

Follow-up

Participants are monitored for safety and effectiveness after continuation treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Enzalutamide
  • ZEN003694
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Experimental: ZEN003694 in Combination with EnzalutamideExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Zenith Epigenetics

Lead Sponsor

Trials
10
Recruited
590+

Published Research Related to This Trial

In the PROSPER trial involving 1401 patients with non-metastatic, castration-resistant prostate cancer, enzalutamide significantly improved metastasis-free survival compared to placebo, indicating its efficacy as a treatment option.
Patients receiving enzalutamide experienced longer times to clinically meaningful pain progression and symptom worsening, while maintaining a high quality of life, suggesting that enzalutamide not only prolongs survival but also enhances overall well-being.
Patient-reported outcomes following enzalutamide or placebo in men with non-metastatic, castration-resistant prostate cancer (PROSPER): a multicentre, randomised, double-blind, phase 3 trial.Tombal, B., Saad, F., Penson, D., et al.[2021]
MDV3100, an androgen receptor antagonist, has been shown to improve survival in men with metastatic castration-resistant prostate cancer who have previously undergone docetaxel chemotherapy, indicating its efficacy in this patient population.
While comprehensive safety and efficacy data are still pending, MDV3100 is considered a well-tolerated option that could complement existing treatments for advanced prostate cancer, alongside other novel therapies like abiraterone and cabazitaxel.
MDV3100 for the treatment of prostate cancer.Mukherji, D., Pezaro, CJ., De-Bono, JS.[2021]
In a phase 3 trial involving 1199 men with castration-resistant prostate cancer, enzalutamide significantly improved overall survival compared to placebo, with a median survival of 18.4 months versus 13.6 months.
Enzalutamide also showed superior efficacy in secondary outcomes, including a 54% reduction in PSA levels and improved quality of life, although it was associated with higher rates of fatigue and other side effects.
Increased survival with enzalutamide in prostate cancer after chemotherapy.Scher, HI., Fizazi, K., Saad, F., et al.[2022]

Citations

Patient-reported outcomes following enzalutamide or placebo in men with non-metastatic, castration-resistant prostate cancer (PROSPER): a multicentre, randomised, double-blind, phase 3 trial. [2021]
MDV3100 for the treatment of prostate cancer. [2021]
Examining initial treatment and survival among men with metastatic prostate cancer: An analysis from the CaPSURE registry. [2021]
Effect of Visceral Disease Site on Outcomes in Patients With Metastatic Castration-resistant Prostate Cancer Treated With Enzalutamide in the PREVAIL Trial. [2021]
Increased survival with enzalutamide in prostate cancer after chemotherapy. [2022]
Vorinostat in advanced prostate cancer patients progressing on prior chemotherapy (National Cancer Institute Trial 6862): trial results and interleukin-6 analysis: a study by the Department of Defense Prostate Cancer Clinical Trial Consortium and University of Chicago Phase 2 Consortium. [2021]
Health-related Quality of Life at the SPARTAN Final Analysis of Apalutamide for Nonmetastatic Castration-resistant Prostate Cancer Patients Receiving Androgen Deprivation Therapy. [2022]
The impact of enzalutamide on quality of life in men with metastatic hormone-sensitive prostate cancer based on prior therapy, risk, and symptom subgroups. [2022]
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