Angelica Herbal Supplement AGN-CognI.Q Acute Dose Safety and Pharmacokinetics (PK) Dose-Response in Prostate Cancer Patients (PK Dose Trial)

PSCI-21-173

This study is to obtain acute dose safety and pharmacokinetics/pharmacodynamics (PK/PD) data in a dose-response trial in prostate cancer patients.

2023-05-02

2024-05-30

2024-11-30

Recruiting

Early phase I

12

Inclusion Criteria: 1. Willingness and ability to give informed consent. 2. Agree to comply with all study procedures and attend all study visits to the best of their ability. 3. Male with age \>=40 years. 4. History of prostate cancer diagnosis in the past. Subjects with history of neuroendocrine or small cell prostate cancer will be excluded. 5. Patients with localized prostate cancer in low-risk group who were not on treatment or declined any treatment are eligible. 6. Patients with localized prostate cancer in favorable intermediate-risk group who declined any treatment are eligible. 7. Not on concurrent androgen deprivation therapy. 8. ECOG performance status 0-2. 9. Life expectancy of greater than 12 months. 10. Subjects must have normal liver and kidney function as defined below: * a) total bilirubin within normal institutional limits, * b) AST(SGOT)/ALT(SGPT) \< 2.5 X institutional upper limit of normal, * c) Creatinine within 1.5 ULN of institutional limits OR creatinine clearance \> 30 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal. * d) Adequate bone marrow function (Hgb ≥ 9.0 g/dL, Platelets ≥ 100 x 109/L, absolute neutrophil count of ≥ 1.5 x 109/L). 11. Subjects must agree to use two medically accepted method of contraception and must agree to continue use this method while on the trial and through at least one week after the last dose of study drug. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD) known to have a failure rate of less than 1% per year, or steroidal contraceptive (oral, transdermal, implanted, or injected) in conjunction with a barrier method. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) withdrawal, spermicides only, or lactational amenorrhea are not acceptable methods of contraception. 12. Subjects must stop the CYP3A4 and CYPC19 strong inhibitors or inducers 2 weeks prior to the start of the study and during the study. 13. Subjects currently taking herbal supplements containing AGN extract, including CognI.Q, Decursinol-50, Ache Action, Fast-Acting Joint Formula, EstroG-100/Profemin must discontinue these or any other supplements continuing these products 4 weeks prior to starting study drug. Exclusion Criteria: 1. Subjects with distant metastatic cancer. Node positive prostate cancer patients are allowed after completion of treatment. 2. Subjects who are receiving chemotherapy, or oral TKI, or immunotherapy (checkpoint inhibitor). 3. Subjects who are receiving any other investigational agents. 4. Uncontrolled intercurrent illness that would limit compliance with study requirements. 5. All vulnerable patient populations. 6. History of New York Heart Association Class III or IV heart failure, history of a myocardial infarction within 6 months, any uncontrolled cardiac arrhythmia, or any other cardiac related problem that would be considered a contraindication for participation in the opinion of the treating physician. 7. Use of androgen deprivation therapy (ADT) or anti-androgen therapy including LHRH agonist, antagonist, GNRH analogs, and antiandrogens. 8. Subjects who are taking Warfarin/Coumadin.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': "After the first subject is enrolled, a 14-day waiting period must occur between each subject before the next subject can be enrolled and dosed. If one subject develops a DLT at any dose level, that subject will cease treatment but will continue safety assessments follow-ups. If a second subject develops a DLT at the same dose level, the trial will be stopped and the dose level below will be the MTD. Any subjects who are at higher dose level at the time of 2nd DLT occurrence, will also stop with no further escalation. All subjects will start at the 800 mg dose (visit 2). Each subject will continue to the next week's dose until a DLT has been reached. However, if 2 DLTs occur at the starting 800 mg dose level, trial will be suspended.", 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ESTIMATED'}}

2024-01-17