Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol
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ClinicalTrials.gov Identifier: NCT04145375 |
Recruitment Status :
Enrolling by invitation
First Posted : October 30, 2019
Last Update Posted : October 30, 2019
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Condition or disease | Intervention/treatment | Phase |
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mCRPC | Drug: ZEN003694 Drug: Enzalutamide | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol |
Estimated Study Start Date : | November 11, 2019 |
Estimated Primary Completion Date : | November 11, 2022 |
Estimated Study Completion Date : | November 11, 2022 |

Arm | Intervention/treatment |
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Experimental: Experimental: ZEN003694 in Combination with Enzalutamide
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
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Drug: ZEN003694
Up to 120mg Drug: Enzalutamide 160mg
Other Names:
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- Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE) [ Time Frame: Up to 3 years ]
- Evaluate radiographic response rate by PCWG2 criteria [ Time Frame: Up to 3 years ]
- 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 [ Time Frame: Up to 3 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- ECOG performance status of 0 or 1
- Acceptable ZEN003694 tolerability, in the judgment of the investigator
- Initiation of dosing in this continuation trial to occur within two weeks (14 days) of completing dosing in the parent trial, unless more time is approved by the sponsor in writing
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
- Any other reason that in the opinion of the Investigator would prevent the patient from completing participation or following the study schedule

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04145375
United States, California | |
University of California San Francisco Medical Center | |
San Francisco, California, United States, 94104 | |
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97239 |
Responsible Party: | Zenith Epigenetics |
ClinicalTrials.gov Identifier: | NCT04145375 History of Changes |
Other Study ID Numbers: |
ZEN003694-500 |
First Posted: | October 30, 2019 Key Record Dates |
Last Update Posted: | October 30, 2019 |
Last Verified: | October 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Zenith prostate cancer |