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

• ClinicalTrials.gov Identifier: NCT04145375
• Recruitment Status: Enrolling by invitation
• First Posted: October 30, 2019
• Last Update Posted: October 30, 2019
• Sponsor: Zenith Epigenetics
• Information provided by (Responsible Party): Zenith Epigenetics

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
mCRPC	Drug: ZEN003694; Drug: Enzalutamide	Phase 1; Phase 2

Detailed Description:

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.

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
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	Drug: ZEN003694; Up to 120mg; Drug: Enzalutamide; 160mg; Other Names: Xtandi; MDV3100

Outcome Measures

Primary Outcome Measures :

1. Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE) [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :

1. Evaluate radiographic response rate by PCWG2 criteria [ Time Frame: Up to 3 years ]
2. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Protocol-defined completion in a parent ZEN003694 trial
2. Patient has clinical benefit as determined by the investigator at the time of entry to the continuation protocol
3. ECOG performance status of 0 or 1
4. Acceptable ZEN003694 tolerability, in the judgment of the investigator
5. 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:

1. Concurrent participation in another clinical investigational treatment trial
2. Require addition of or change to a new concomitant therapy to adequately treat the malignancy under study
3. Discontinued ZEN003694 or withdrew consent to participate in original Zenith Epigenetics-sponsored ZEN003694 study
4. Any other reason that in the opinion of the Investigator would prevent the patient from completing participation or following the study schedule

Contacts and Locations

Locations

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

Sponsors and Collaborators

Zenith Epigenetics

More Information

• Responsible Party: Zenith Epigenetics
• ClinicalTrials.gov Identifier: NCT04145375 History of Changes
• Other Study ID Numbers: ZEN003694-500
• First Posted: October 30, 2019
• 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

Keywords provided by Zenith Epigenetics:

Zenith; prostate cancer