[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04145375":3,"trial-entities:NCT04145375":84,"trial-summary:NCT04145375":88},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":6,"detailed_description":15,"conditions":16,"keywords":18,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":26,"interventions":29,"primary_outcomes":43,"secondary_outcomes":47,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":14,"eligibility_criteria":55,"std_ages":59,"locations":62,"central_contacts":80,"overall_officials":81,"references":82,"see_also_links":83},"NCT04145375","ZEN003694-500","Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol","ENROLLING_BY_INVITATION","2027-12-31","2026-05","2026-05-08","2019-11-12","Zenith Epigenetics","INDUSTRY",false,"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.",[17],"mCRPC",[19,20],"Zenith","prostate cancer","INTERVENTIONAL","TREATMENT",[24,25],"PHASE1","PHASE2",{"count":27,"type":28},40,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","ZEN003694","Up to 120mg",[35],"Experimental: ZEN003694 in Combination with Enzalutamide",{"type":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Enzalutamide","160mg",[35],[41,42],"Xtandi","MDV3100",[44],{"measure":45,"timeFrame":46},"Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE)","Up to 3 years",[48,50],{"measure":49,"timeFrame":46},"Evaluate radiographic response rate by RECIST 1.1 criteria",{"measure":51,"timeFrame":46},"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","ALL","18 Years",null,{"inclusion":56,"exclusion":57,"raw_text":58},[],[],"Inclusion Criteria:\n\n1. Protocol-defined completion in a parent ZEN003694 trial\n2. Patient has clinical benefit as determined by the investigator at the time of entry to the continuation protocol\n3. ECOG performance status of 0 or 1\n4. Acceptable ZEN003694 tolerability, in the judgment of the investigator\n5. 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\n\nExclusion Criteria:\n\n1. Concurrent participation in another clinical investigational treatment trial\n2. Require addition of or change to a new concomitant therapy to adequately treat the malignancy under study\n3. Discontinued ZEN003694 or withdrew consent to participate in original Zenith Epigenetics-sponsored ZEN003694 study\n4. Any other reason that in the opinion of the Investigator would prevent the patient from completing participation or following the study schedule",[60,61],"ADULT","OLDER_ADULT",[63,72],{"facility":64,"city":65,"state":66,"zip":67,"country":68,"geoPoint":69},"University of California San Francisco Medical Center","San Francisco","California","94104","United States",{"lat":70,"lon":71},37.77493,-122.41942,{"facility":73,"city":74,"state":75,"zip":76,"country":68,"geoPoint":77},"Oregon Health & Science University","Portland","Oregon","97239",{"lat":78,"lon":79},45.52345,-122.67621,[],[],[],[],{"nct_id":4,"conditions":85,"biomarkers":87},[86],"Prostate Carcinoma",[],{"nct_id":4,"found":89,"summary":90,"prompt_version":100},true,{"design":91,"status":92,"heading":93,"summary":94,"follow_up":95,"word_count":96,"commitments":97,"compensation":98,"drugs_mentioned":99},"This is an open-label, non-randomized study, meaning everyone receives the same treatment and you and your doctors will know what you are taking. It aims to enroll about 40 participants.","completed","Continuation Study for ZEN003694 in Metastatic Castration-Resistant Prostate Cancer","This study is for people with metastatic castration-resistant prostate cancer (mCRPC), meaning prostate cancer that has spread and no longer responds to treatments that lower testosterone. It's a continuation study for those who have already participated in a ZEN003694 trial and are still benefiting from the treatment. You would continue to receive ZEN003694, possibly along with Enzalutamide. The main goal is to track any side effects (adverse events) you might experience while taking ZEN003694. To join, you must have completed a previous ZEN003694 study, be showing clinical benefit, and have a good performance status (ECOG 0 or 1).","Your treatment-related side effects will be monitored for up to 3 years.",98,"You would continue to receive ZEN003694, potentially up to 120mg, and possibly Enzalutamide at 160mg. The study will monitor for side effects for up to 3 years.","Not stated in the trial record.",[32,37],"v2"]