By InvitationPhase 1/2

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

United States40 participantsStarted 2019-11-12

Plain-language summary

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Protocol-defined completion in a parent ZEN003694 trial
✓. Patient has clinical benefit as determined by the investigator at the time of entry to the continuation protocol
✓. ECOG performance status of 0 or 1
✓. Acceptable ZEN003694 tolerability, in the judgment of the investigator
✓. 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

✕. Concurrent participation in another clinical investigational treatment trial
✕. Require addition of or change to a new concomitant therapy to adequately treat the malignancy under study
✕. Discontinued ZEN003694 or withdrew consent to participate in original Zenith Epigenetics-sponsored ZEN003694 study
✕. Any other reason that in the opinion of the Investigator would prevent the patient from completing participation or following the study schedule

Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE)

Timeframe: Up to 3 years

NCT IDNCT04145375

SponsorZenith Epigenetics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-31