Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: ZEN003694 in Combination with Enzalutamide | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZEN003694 | Drug | Up to 120mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE) | Up to 3 years |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco Medical Center | San Francisco | California | 94104 | United States | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C540278 | enzalutamide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Enzalutamide |
| Drug |
160mg |
|
|
| Oregon Health & Science University |
| Portland |
| Oregon |
| 97239 |
| United States |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |