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

Sponsor: Zenith Epigenetics

Sponsor score: 0

ClinicalTrials ID:NCT04145375

This open-label, single-arm study allows patients who benefited from a prior ZEN003694 trial to continue treatment. Eligibility requires protocol completion, clinical benefit, ECOG status 0-1, and acceptable tolerability. Treatment includes ZEN003694 (up to 120mg) and Enzalutamide (160mg), starting within 14 days post-parent trial, unless otherwise approved.

Patient Parameters

Program Overview

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.

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

Locations

FACILITYZIPCITYSTATE
University of California San Francisco Medical Center94104San FranciscoCalifornia
Oregon Health & Science University97239PortlandOregon

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