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

• ClinicalTrials.gov Identifier: NCT04145375
• Recruitment Status: Enrolling by invitation
• First Posted: October 30, 2019
• Last Update Posted: October 30, 2019
• Sponsor: Zenith Epigenetics
• Information provided by (Responsible Party): Zenith Epigenetics

Tracking Information

• First Submitted Date: October 28, 2019
• First Posted Date: October 30, 2019
• Last Update Posted Date: October 30, 2019
• Estimated Study Start Date: November 11, 2019
• Estimated Primary Completion Date: November 11, 2022 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 28, 2019): Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE) [ Time Frame: Up to 3 years ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 28, 2019)

• Evaluate radiographic response rate by PCWG2 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol
• Official Title: Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol
• 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.
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: mCRPC

Intervention

• Drug: ZEN003694
  Up to 120mg
• Drug: Enzalutamide
  160mg
  Other Names:

  • Xtandi
  • MDV3100

Study Arms

Experimental: Experimental: ZEN003694 in Combination with Enzalutamide

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

Interventions:

• Drug: ZEN003694
• Drug: Enzalutamide

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: October 28, 2019): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 11, 2022
• Estimated Primary Completion Date: November 11, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04145375
• Other Study ID Numbers: ZEN003694-500
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Zenith Epigenetics
• Study Sponsor: Zenith Epigenetics
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Zenith Epigenetics
• Verification Date: October 2019