GZ17-6.02 for Prostate Cancer

Overseen By Massey IIT Research Operations

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Virginia Commonwealth University

Must be taking: Androgen deprivation therapy

Must not be taking: MAOIs, CYP inhibitors, PARP inhibitors

Disqualifiers: Brain metastasis, Hepatitis B/C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this clinical trial is to determine if GZ17-6.02 delays progression of castration-resistant prostate cancer.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does require stopping certain drugs that might interact with the study treatment at least 2 weeks before starting. If you're taking monoamine oxidase inhibitors, you need to stop them 10 days before starting the trial.

Research Team

John Melson, MD

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

Men with advanced prostate cancer that's resistant to hormone therapy can join this trial. They must have rising PSA levels, adequate blood counts, and agree to use contraception if they have partners who could become pregnant. Participants need normal liver and kidney function, no severe infections or brain metastases, and a performance status indicating they are relatively active.

Inclusion Criteria

My PSA levels have increased over two tests at least a week apart.

Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3

Platelets ≥100,000 cells/mm3

Exclusion Criteria

Any investigational agent within 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

I have a condition that affects how my body absorbs nutrients.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GZ17-6.02, a combination of curcumin, harmine, and isovanillin, 375mg twice daily

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Treatment Details

Interventions

• GZ17-6.02

Trial Overview The trial is testing GZ17-6.02 to see if it slows down the progression of castration-resistant prostate cancer in patients who've already tried anti-androgen therapy. It involves taking an investigational drug made from curcumin, harmine, and isovanillin.

Participant Groups

Group I: Investigational Agent Administration Experimental Treatment 1 Intervention

GZ17-6.02: 375mg twice daily

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+