ZEN003694 Continuation for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Zenith Epigenetics

No Placebo Group

Trial Summary

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.

Research Team

Eligibility Criteria

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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Treatment Details

Interventions

Enzalutamide (Hormone Therapy)
ZEN003694 (Other)

Trial OverviewThe 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.

Participant Groups

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