The purpose of this clinical trial is to determine if GZ17-6.02 delays progression of castration-resistant prostate cancer.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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
Virginia Commonwealth University
Richmond, Virginia, United States
RECRUITINGRadiologic 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
Measure the biochemical response rate of CRPC tumors to GZ17-6.02
Biochemical response measured by percentage of patients with any reduction in PSA, reduction in PSA by at least 30% (PSA30), and reduction in PSA by at least 50% (PSA50).
Time frame: Up to 5 years following end of study treatment
Measure the duration of response of CRPC tumors to GZ17-6.02
Duration of tumor response, measured by time to increase in PSA.
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.
Best objective response (complete response, partial response, or stable disease ≥4 months) in patients with measurable disease by RECIST 1.1.
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
Duration of radiographic response
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
Overall patient survival, defined as date of diagnosis to date of death
Time frame: Up to 5 years following end of study treatment
Determine the safety and tolerability of twice daily treatment with GZ17-6.02
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Incidence of adverse events using Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: Beginning of study treatment through the 30-day follow-up safety assessment up to 5 years