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

Study Overview
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Brief Summary
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Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol

Detailed Description
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This is an open label, non-randomized, single-arm continuation protocol study using ZEN003694. Patients who have completed participation in their original (parent) ZEN003694 protocol and have clinical benefit as determined by the investigator may continue to receive treatment with ZEN003694 in the continuation protocol. The patient must have been enrolled in a Zenith Epigenetics sponsored ZEN003694 therapeutic study to be eligible for participation in this continuation protocol.

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

Conditions
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mCRPC

Intervention / Treatment
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* Drug: ZEN003694
* Drug: Enzalutamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: ZEN003694 in Combination with Enzalutamide<br>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 | Drug: ZEN003694<br>* Up to 120mg<br>Drug: Enzalutamide<br>* 160mg<br>* Other names: MDV3100;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE) |  | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate radiographic response rate by RECIST 1.1 criteria |  | 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 |  | Up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zenith, prostate cancer