mCRPC
Conditions
Keywords
Zenith, prostate cancer
Brief summary
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
DRUGZEN003694
Up to 120mg
DRUGEnzalutamide
160mg
Sponsors
Zenith Epigenetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE) | Up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate radiographic response rate by RECIST 1.1 criteria | 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 | Up to 3 years |
Countries
United States
Outcome results
None listed