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

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ClinicalTrials.gov Identifier: NCT04145375
Recruitment Status : Enrolling by invitation
First Posted : October 30, 2019
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Zenith Epigenetics

Study Description
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Brief Summary:
Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol

Condition or disease Intervention/treatment Phase
mCRPC Drug: ZEN003694 Drug: Enzalutamide Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol
Actual Study Start Date : November 12, 2019
Estimated Primary Completion Date : November 11, 2022
Estimated Study Completion Date : November 11, 2022

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Arms and Interventions
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Arm Intervention/treatment
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
 Drug: ZEN003694
Up to 120mg

Drug: Enzalutamide
160mg
Other Names:
  • Xtandi
  • MDV3100


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE) [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. Evaluate radiographic response rate by RECIST 1.1 criteria [ Time Frame: Up to 3 years ]
  2. 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04145375


Locations
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United States, California
University of California San Francisco Medical Center
San Francisco, California, United States, 94104
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Zenith Epigenetics
More Information
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Responsible Party: Zenith Epigenetics
ClinicalTrials.gov Identifier: NCT04145375    
Other Study ID Numbers: ZEN003694-500
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zenith Epigenetics:
Zenith
prostate cancer