Actively Recruiting
GZ17-6.02 in Advanced Castration-Resistant Prostate Cancer After Progression on Anti-Androgen Therapy
Led by Virginia Commonwealth University · Updated on 2026-01-27
30
Participants Needed
1
Research Sites
235 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether GZ17-6.02 can delay the progression of castration-resistant prostate cancer in men who have previously undergone androgen deprivation therapy and treatment with an androgen receptor pathway inhibitor. It is a phase Ib single-arm study focusing on men with advanced prostate cancer that no longer responds to hormone therapies. The study also aims to assess the safety and tolerability of GZ17-6.02 while exploring patient-reported outcomes. Participants will receive GZ17-6.02 orally at a fixed dose of 375 mg twice daily with a high-fat meal, following a 28-day cycle that continues until disease progression or intolerable side effects occur. This study involves only one treatment group where all participants receive the investigational agent. The treatment is a combination of curcumin, harmine, and isovanillin. There is no placebo or comparison group. During the study, participants will be monitored through imaging scans such as CT and bone scans to assess disease progression. Researchers will measure radiologic progression-free survival over 6 months and up to 5 years after treatment ends. Other evaluations include biochemical responses, duration of tumor response, overall survival, and safety assessments up to 5 years post-treatment. Participants will have follow-up visits including a 30-day safety check after treatment completion.
CONDITIONS
Brief Title
GZ17-6.02 in Advanced CRPC After Progression on Anti-Androgen Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with prostate cancer and treated with androgen deprivation therapy and at least one androgen receptor pathway inhibitor
- Androgen levels of 50 ng/dL or lower
- Evidence of disease progression after prior hormone therapies
- PSA progression confirmed by two rising assessments at least 7 days apart
- Measurable disease by RECIST v1.1 on CT scan or evaluable disease on bone scan
- ECOG performance status of 0, 1, or 2
- Adequate liver function with total bilirubin ≤1.5 times upper limit of normal and ALT and AST ≤3 times upper limit of normal
- Adequate kidney function with creatinine clearance ≥30 mL/min
- Absolute neutrophil count ≥1,500 cells/mm3
- Platelet count ≥100,000 cells/mm3
- Serum hemoglobin level ≥8 g/dL
- Agree to not donate blood or sperm during the study and for 90 days after last dose
- Use highly effective contraception if having sexual partners of childbearing potential
- Ability and willingness to provide written informed consent
You will not qualify if you...
- Use of any investigational agent within 4 weeks or less than 5 half-lives before starting study treatment
- Low PSA (≤10 ng/mL) at initial presentation with high volume (≥20) bone metastases
- Enrollment in another cancer treatment clinical trial
- Active, uncontrolled diarrhea causing dehydration or electrolyte imbalance
- Grade 3 or higher uncontrolled infection
- Major surgery within 3 weeks before starting study treatment
- Not fully recovered to grade 1 or lower from surgery-related side effects within 3 weeks prior to study
- Presence of small cell, anaplastic, or neuroendocrine prostate cancer components
- Known active brain metastases or leptomeningeal disease
- Use of drugs with potential adverse interactions that cannot be stopped 2 weeks before treatment, including MAO inhibitors and certain liver enzyme inhibitors
- Inability to swallow medication
- Known allergy to components of GZ17-6.02 or its excipients
- Known or suspected malabsorption or obstruction
- Active untreated hepatitis B or C
- Known liver cirrhosis, active nonalcoholic steatohepatitis, or fatty liver disease
- Medical, psychological, or social conditions that may increase risk or limit adherence to study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until progression or intolerable toxicity
Participants take the investigational drug GZ17-6.02 orally with a high-fat meal twice daily during 28-day cycles until disease progression or intolerable side effects occur.
Regular visits to monitor health and response during treatment cycles
Duration - Up to 5 years after end of study treatment
Participants are monitored for safety, tolerability, and long-term outcomes after stopping treatment.
Periodic follow-up visits during the 30-day safety assessment and long-term monitoring up to 5 years
Trial Site Locations
Total: 1 location
1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
M
Massey IIT Research Operations
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here