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

Sponsor
Zenith Epigenetics (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04145375
Collaborator
(none)
40
Enrollment
2
Locations
1
Arm
37.6
Anticipated Duration (Months)
20
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
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

Study Type:
Interventional
Anticipated 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 :
Nov 12, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

    Primary Outcome Measures

    1. Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE) [Up to 3 years]

    Secondary Outcome Measures

    1. Evaluate radiographic response rate by RECIST 1.1 criteria [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 [Up to 3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California San Francisco Medical Center San Francisco California United States 94104
    2 Oregon Health & Science University Portland Oregon United States 97239

    Sponsors and Collaborators

    • Zenith Epigenetics

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zenith Epigenetics
    ClinicalTrials.gov Identifier:
    NCT04145375
    Other Study ID Numbers:
    • ZEN003694-500
    First Posted:
    Oct 30, 2019
    Last Update Posted:
    Jun 1, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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

    Study Results

    No Results Posted as of Jun 1, 2022