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

NCT ID: NCT04145375

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-12
• Study Completion Date: 2026-12-31

Brief Summary

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

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.

Conditions

mCRPC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

ZEN003694

Intervention Type: DRUG

Up to 120mg

Enzalutamide

Intervention Type: DRUG

160mg

Interventions

ZEN003694

Up to 120mg

Intervention Type: DRUG

Enzalutamide

160mg

Intervention Type: DRUG

Other Intervention Names

Xtandi; MDV3100

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zenith Epigenetics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of California San Francisco Medical Center

San Francisco, California, United States

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

ZEN003694-500

Identifier Type: -

Identifier Source: org_study_id