AGN-CognI.Q Acute Dose Safety and Pharmacokinetics Dose-Response in Prostate Cancer Patients

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milton S. Hershey Medical Center

Criteria

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. Histologically confirmed prostate cancer diagnosis in the past. Subjects with history of neuroendocrine or small cell prostate cancer histology will be excluded.

5. Not on concurrent androgen deprivation therapy.

6. ECOG performance status 0-2.

7. Life expectancy of greater than 12 months.

8. 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).

9. 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.

Exclusion Criteria:

1. Subjects with metastatic cancer as determined by chest and abdominal CT scan, PET/CT (conventional FDG or prostate specific imaging such as AXUMIN or PSMA directed PET), MRI, bone scan within the past 12 months. Choice of imaging is per physician's discretion.

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. Subjects currently taking herbal supplements containing AGN extract, including CognI.Q, Decursinol-50, Ache Action, Fast-Acting Joint Formula, EstroG-100/Profemin. However, they could be enrolled after discontinuation and washout for 4 weeks from the last dose.

6. All vulnerable patient populations.

7. 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.

8. Use of androgen deprivation therapy (ADT) or anti-androgen therapy including LHRH agonist, antagonist, GNRH analogs, and antiandrogens.