[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564972":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":49,"collaborators":19,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":19,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":19,"enrollmentInfo":60,"targetDuration":19,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":19,"overallStatus":32,"whyStopped":19,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Virginia Commonwealth University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Investigational Agent Administration","EXPERIMENTAL","GZ17-6.02: 375mg twice daily",[13],"Drug: Investigational Agent Administration",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","GZ17-6.02 will be taken orally with a high-fat meal at a fixed dose of 375 mg twice daily each day of a 28-day cycle, continuing until progression or intolerable toxicity",[9],null,[21],{"name":22,"affiliation":5,"role":23},"John Melson, MD","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Massey IIT Research Operations","CONTACT","804-628-6430","masseyepd@vcu.edu",[31],{"facility":5,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Richmond","Virginia","23298","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-77.46026,37.55376,{"lat":42,"lon":41},[45,48],{"name":46,"role":27,"phone":28,"phoneExt":19,"email":47},"Massey CTO GU Team","masseygu@vcu.edu",{"name":22,"role":23,"phone":19,"phoneExt":19,"email":19},{"type":50,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100564972","phase-1-gz17-602-in-advanced-crpc-after-progression-on-anti-androgen-therapy-100564972",false,"NCT06636123","GZ17-6.02 in Advanced CRPC After Progression on Anti-Androgen Therapy","GZ17-6.02 in Advanced Castration-Resistant Prostate Cancer (CRPC) After Progression on Anti-Androgen Therapy","Inclusion Criteria:\n\n* Patients diagnosed with prostate cancer and treated with androgen deprivation therapy (ADT) and at least one androgen receptor pathway inhibitor (ARPI) (eg, abiraterone, enzalutamide, apalutamide or darolutamide). Previous prostate-specific membrane antigen (PSMA)-targeted therapy or cytotoxic chemotherapy is allowed but not required.\n* Androgen levels ≤50 ng\u002FdL (≤1.73 nmol\u002FL).\n* Disease progression following ADT and ARPI treatment described\n* PSA progression over 2 assessments, defined as rising PSA values from 2 consecutive assessments with an interval of at least 7 days between assessments. PSA levels prior to study enrollment are considered and appropriate for inclusion.\n* Measurable disease by RECIST v1.1 on chest\u002Fabdomen\u002Fpelvis CT or evaluable disease observed on bone scan.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2\n* Appropriate hepatic function defined by a total bilirubin (TBL) ≤1.5 × the upper limit of normal (ULN), alanine aminotransferase (ALT) AND aspartate aminotransferase (AST) ≤3 × ULN at screening.\n* Appropriate kidney function defined by calculated or actual creatinine clearance ≥30 mL\u002Fmin\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3.\n* Platelets ≥100,000 cells\u002Fmm3.\n* Serum hemoglobin level ≥8 g\u002FdL.\n* Agree to not donate blood or sperm during the study and for 90 days after the last dose of study treatment.\n* Patients with sexual partners of childbearing potential must agree to use highly effective methods of contraception throughout the study\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Any investigational agent:\n\nwithin 4 weeks OR within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, before initiating study treatment.\n\n* Low PSA (≤10 ng\u002FmL) at initial presentation (before ADT or at symptomatic progression in the castrate setting) plus high volume (≥20) bone metastases.\n* Simultaneous enrollment in any other cancer treatment interventional clinical trial.\n* Active, uncontrolled diarrhea leading to dehydration or electrolyte disturbances not controlled with oral repletion.\n* Grade ≥3 uncontrolled infection.\n* Major surgery (in the opinion of the treating investigator) ≤3 weeks before initiating study treatment.\n* Not having fully recovered to a grade of 1 or lower from any surgery-related adverse effects within the 3 weeks preceding the start of the study treatment.\n* Small cell, anaplastic, or neuroendocrine component.\n* Known active brain metastasis.\n* Known active leptomeningeal disease.\n* Planned ongoing treatment with other drugs thought to potentially have adverse interactions with either of the medications included in the study treatment must be discontinued ≥2 weeks prior to initiating study treatment unless otherwise noted:\n\n  * Monoamine oxidase inhibitors (MAOI) use; must discontinue use 10 days prior to initiating study therapy.\n  * Strong or moderate CYP1A2, CYP3A4 and CYP2C19 inhibitors.\n  * Rucaparib, Olaparib and Talazoparib, due to their common findings of liver enzyme elevation.\n* Inability to swallow medication.\n* Known hypersensitivity to GZ17-6.02 components (curcumin, harmine, and isovanillin) or excipients.\n* Known or suspected malabsorption condition or obstruction.\n* Active untreated hepatitis B or C\" and \"Known liver cirrhosis of any cause, active nonalcoholic steatohepatitis, or nonalcoholic fatty liver disease. Note: no additional testing necessary to confirm\n* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements","MALE","18 Years",{"count":61,"type":62},30,"ESTIMATED","INTERVENTIONAL",[65],"PHASE1","The purpose of this clinical trial is to determine if GZ17-6.02 delays progression of castration-resistant prostate cancer.",[68],"Castration-resistant Prostate Cancer","2026-01-23",{"date":71,"type":72},"2026-01-27","ACTUAL",{"date":74,"type":72},"2025-02-18",{"date":76,"type":62},"2031-10-31",{"name":5,"class":6},1]