Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ZEN003694, Enzalutamide.
- Who it may be relevant to
- Registry conditions: mCRPC. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol
Detailed description
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.
Interventions
- Drug ZEN003694
Up to 120mg - Drug Enzalutamide
160mg
Primary outcome measures
- Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE) [Time frame: Up to 3 years]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- University of California San Francisco Medical Center — San Francisco
- Oregon Health & Science University — Portland
Identifiers
NCT: NCT04145375 · ZEN003694-500