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)
Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE) — Up to 3 years
Trial sites (2)
Facility
City
Region
Status
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.
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