GZ17-6.02 in Advanced Castration-Resistant Prostate Cancer (CRPC) After Progression on Anti-Androgen Therapy
Virginia Commonwealth University
Summary
The purpose of this clinical trial is to determine if GZ17-6.02 delays progression of castration-resistant prostate cancer.
Description
This single-arm phase Ib study will assess whether GZ17-6.02, a combination of curcumin, harmine, and isovanillin, delays radiographic progression of castration-resistant prostate cancer among men previously treated with androgen deprivation therapy and an androgen receptor pathway inhibitor. All participants in the study will receive GZ17-6.02. The study will also assess the safety and tolerability of GZ17-6.02 and explore patient-reported outcomes.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * 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. * Androgen levels ≤50 ng/dL (≤1.73 nmol/L). * Disease progression following ADT and ARPI treatment described * PSA progression over 2 assessments, defined as rising PSA values from 2 consecutive assessments with an interval of at least 7 da…
Interventions
- DrugInvestigational Agent Administration
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
Location
- Virginia Commonwealth UniversityRichmond, Virginia