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

mCRPC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04145375
• Other study ID #: ZEN003694-500
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• Start date: November 12, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Zenith Epigenetics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• mCRPC

Intervention

Drug:
• ZEN003694
Up to 120mg
• Enzalutamide
160mg

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon
United States	University of California San Francisco Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Zenith Epigenetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE)		Up to 3 years
Secondary	Evaluate radiographic response rate by RECIST 1.1 criteria		Up to 3 years
Secondary	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