GZ17-6.02 in Advanced Castration-Resistant Prostate Cancer (CRPC) After Progression on Anti-Androgen Therapy
Summary
The purpose of this clinical trial is to determine if GZ17-6.02 delays progression of castration-resistant prostate cancer.
Detailed 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.
Arms & 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
Outcome measures
Primary
Radiologic progression-free survival (rPFS) for 6 months or longer
Number of participants with rPFS for 6 months or longer
Time frame: 6 months and up to 5 years after end of study treatment
Secondary
Measure the biochemical response rate of CRPC tumors to GZ17-6.02
Time frame: Up to 5 years following end of study treatment
Measure the duration of response of CRPC tumors to GZ17-6.02
Time frame: Up to 5 years following end of study treatment
Assess the objective response rate (ORR) in CRPC patients treated with twice daily GZ17-6.02.
Time frame: Up to 5 years following end of study treatment
Measure the duration of radiographic response in CRPC patients treated with twice daily GZ17-6.02
Time frame: Up to 5 years following end of study treatment
Measure overall survival (OS) in CRPC patients treated with twice daily GZ17-6.02
Time frame: Up to 5 years following end of study treatment
Determine the safety and tolerability of twice daily treatment with GZ17-6.02
Time frame: Beginning of study treatment through the 30-day follow-up safety assessment up to 5 years
Eligibility criteria
Study locations (1)
Virginia Commonwealth University
Richmond, Virginia, 23298