Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Up to 120mg
160mg
University of California San Francisco Medical Center
San Francisco, California, United States
Oregon Health & Science University
Portland, Oregon, United States
Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE)
Time frame: Up to 3 years
Evaluate radiographic response rate by RECIST 1.1 criteria
Time frame: 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
Time frame: Up to 3 years
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