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New treatment option for Castration-resistant Prostate Cancer
Official title GZ17-6.02 in Advanced CRPC After Progression on Anti-Androgen Therapy
ClinicalTrials.gov ID: NCT06636123
What this study is testing
What is Investigational Agent Administration?
Investigational Agent Administration is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for castration-resistant prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this clinical trial is to determine if GZ17-6.02 delays progression of castration-resistant prostate cancer.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Patients diagnosed with prostate cancer and treated with androgen deprivation therapy (ADT) and at least one androgen receptor pathway inhibitor...
- 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 days between...
- Measurable disease by RECIST v1.1 on chest/abdomen/pelvis CT or evaluable disease observed on bone scan.
You likely can't join if
- Any investigational agent: within 4 weeks OR within a time interval less than at least 5 half-lives of the investigational agent, whichever is...
- Low PSA (≤10 ng/mL) at initial presentation (before ADT or at symptomatic progression in the castrate setting) plus high volume (≥20) bone metastases.
- Simultaneous enrollment in any other cancer treatment treatment clinical trial.
- Active, uncontrolled diarrhea leading to dehydration or electrolyte disturbances not controlled with oral repletion.
- Grade ≥3 uncontrolled infection.
- Major surgery (in the opinion of the treating investigator) ≤3 weeks before initiating study treatment.
See the full eligibility 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)...
- 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 days between assessments. PSA levels prior to study enrollment are considered and...
- Measurable disease by RECIST v1.1 on chest/abdomen/pelvis CT or evaluable disease observed on bone scan.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Appropriate hepatic function defined by a total bilirubin (TBL) ≤1.5 × the upper limit of normal (ULN), alanine aminotransferase (ALT) AND aspartate aminotransferase (AST) ≤3 × ULN at screening.
- Appropriate kidney function defined by calculated or actual creatinine clearance ≥30 mL/min
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3.
- Platelets ≥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 the last dose of study treatment.
- Patients with sexual partners of childbearing potential must agree to use highly effective methods of contraception throughout the study
- Ability to understand and the willingness to sign a written informed consent document
- 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.
- Low PSA (≤10 ng/mL) at initial presentation (before ADT or at symptomatic progression in the castrate setting) plus high volume (≥20) bone metastases.
- Simultaneous enrollment in any other cancer treatment treatment clinical trial.
- Active, uncontrolled diarrhea leading to dehydration or electrolyte disturbances not controlled with oral repletion.
- Grade ≥3 uncontrolled infection.
- Major surgery (in the opinion of the treating investigator) ≤3 weeks before initiating study treatment.
- Not having fully recovered to a grade of 1 or lower from any surgery-related adverse effects within the 3 weeks preceding the start of the study treatment.
- Small cell, anaplastic, or neuroendocrine component.
- Known active brain metastasis.
- Known active leptomeningeal disease.
- Planned ongoing treatment with other drugs thought to potentially have adverse interactions with either of the medications included in the study treatment must be discontinued ≥2 weeks prior to initiating study...
- Monoamine oxidase inhibitors (MAOI) use; must discontinue use 10 days prior to initiating study therapy.
- Strong or moderate CYP1A2, CYP3A4 and CYP2C19 inhibitors.
- Rucaparib, Olaparib and Talazoparib, due to their common findings of liver enzyme elevation.
- Inability to swallow medication.
- Known hypersensitivity to GZ17-6.02 components (curcumin, harmine, and isovanillin) or excipients.
- Known or suspected malabsorption condition or obstruction.
- Active untreated hepatitis B or C" and "Known liver cirrhosis of any cause, active nonalcoholic steatohepatitis, or nonalcoholic fatty liver disease. Note: no additional testing necessary to confirm
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Richmond, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.