Zenith Epigenetics
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.
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. Requ…
Up to 120mg
160mg
Arctuva estimate
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