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Clinical Trials in the USA / NCT04145375
Enrolling by invitation Phase 1/2

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

NCT04145375 · tracked via the Priya Life Science USA tracker
Sponsor
Zenith Epigenetics
Phase
Phase 1/2
Started
2019-11-12
Last updated
2026-05-08

Condition(s) studied

mCRPC

Investigational drug(s) / intervention(s)

ZEN003694Enzalutamide

ZEN003694: Up to 120mg

Enzalutamide: 160mg

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
University of California San Francisco Medical Center San Francisco California
Oregon Health & Science University Portland Oregon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04145375 on ClinicalTrials.gov ↗ ← All trials in the USA