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

• Status: Enrolling by invitation
• Trial end date: 2022-11-11
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zenith Epigenetics

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