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

NCT04145375 | Enrolling By Invitation Phase 1 FDA Drug

• 1 other identifier: ZEN003694-500
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

mCRPC

Keywords

Zenith; prostate cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE)

  Up to 3 years

Secondary Outcomes (2)

• 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

Study Arms (1)

Experimental: ZEN003694 in Combination with Enzalutamide

EXPERIMENTAL

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; Drug: Enzalutamide

Interventions

ZEN003694 DRUG

Up to 120mg

Experimental: ZEN003694 in Combination with Enzalutamide

Enzalutamide DRUG

160mg

Also known as: Xtandi, MDV3100

Experimental: ZEN003694 in Combination with Enzalutamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zenith Epigenetics: lead

Study Sites (2)

University of California San Francisco Medical Center

San Francisco, California, 94104, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

enzalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: November 12, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)