Clinical trial · Interventional
Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol
NCT04145375CI-TRIAL-00110860enrolling by invitationPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| mCRPC | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enzalutamide | Drug | Enzalutamide | ALIAS |
| ZEN003694 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: ZEN003694 in Combination with Enzalutamide
- description
- Patients who have completed participation in their original ZEN003694-002 protocol and have clinical benefit as determined by the investigator may continue to receive treatment with ZEN003694 in combination with enzalutamide
- interventionNames
- Drug: ZEN003694
- Drug: Enzalutamide
Primary outcomes (1)
- measure
- Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE)
- timeFrame
- Up to 3 years
Secondary outcomes (2)
- measure
- Evaluate radiographic response rate by RECIST 1.1 criteria
- timeFrame
- Up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.