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

Disqualifiers: Other trials, New therapies, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 5 6 7 8}

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

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

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?

Group I: Experimental: ZEN003694 in Combination with Enzalutamide Experimental Treatment 2 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased survival with enzalutamide in prostate cancer after chemotherapy. Scher, HI., Fizazi, K., Saad, F., et al.[2022]

In the SPARTAN study involving 1207 patients with nonmetastatic castration-resistant prostate cancer, apalutamide significantly improved health-related quality of life (HRQoL) compared to placebo, with patients maintaining better scores over time.

Patients receiving apalutamide experienced minimal side effects and reported no worsening of fatigue, while those on placebo showed a decline in quality of life after about one year, highlighting the efficacy and tolerability of apalutamide in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-related Quality of Life at the SPARTAN Final Analysis of Apalutamide for Nonmetastatic Castration-resistant Prostate Cancer Patients Receiving Androgen Deprivation Therapy. Oudard, S., Hadaschik, B., Saad, F., et al.[2022]

In a phase 3 study with 1150 patients, enzalutamide combined with androgen deprivation therapy (ADT) significantly delayed the time to first confirmed clinically meaningful deterioration in pain and health-related quality of life (HRQoL) compared to ADT alone.

Specific subgroups, such as those with prior radiotherapy or low baseline HRQoL, experienced notable benefits, with enzalutamide delaying the worsening of pain and maintaining high HRQoL scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of enzalutamide on quality of life in men with metastatic hormone-sensitive prostate cancer based on prior therapy, risk, and symptom subgroups. Stenzl, A., Szmulewitz, RZ., Petrylak, D., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

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]

2. England pubmed.ncbi.nlm.nih.gov

MDV3100 for the treatment of prostate cancer. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Examining initial treatment and survival among men with metastatic prostate cancer: An analysis from the CaPSURE registry. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of Visceral Disease Site on Outcomes in Patients With Metastatic Castration-resistant Prostate Cancer Treated With Enzalutamide in the PREVAIL Trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Increased survival with enzalutamide in prostate cancer after chemotherapy. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

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]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Health-related Quality of Life at the SPARTAN Final Analysis of Apalutamide for Nonmetastatic Castration-resistant Prostate Cancer Patients Receiving Androgen Deprivation Therapy. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

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]