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

  • Active Not Recruiting
  • Treatment
  • Interventional
  • Drug
  • PHASE1
  • Milton S. Hershey Medical Center
  • 40 Years -


Study Purpose

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

Intervention

Drug : AGN-CognI.Q


Eligibility Requirements

info icon Willingness and ability to give informed consent.

info icon Agree to comply with all study procedures and attend all study visits to the best of their ability.

info icon Male with age \>=40 years.

info icon History of prostate cancer diagnosis. Subjects with history of neuroendocrine or small cell prostate cancer will be excluded. Subjects are eligible if meet one or more of the below criteria: 1. Patients treated forprostate cancer and no detectable disease on imaging and clinical determination are eligible for enrollment, regardless of risk category. 2. Patients in the low-risk and favorable intermediate-risk groups who are not currently receiving any treatment or have declined any treatment.

info icon Not on concurrent androgen deprivation therapy.

info icon ECOG performance status 0-2.

info icon Life expectancy of greater than 12 months.

info icon 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 \> 50 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 (ANC) of ≥ 1.5 x 109/L), except for subjects with a history of chronic benign neutropenia, where an ANC of ≥ 1.0 x 109/L are eligible.

info icon 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.

info icon Subjects must stop the CYP3A4 and CYP2C19 strong inhibitors or inducers 2 weeks prior to the start of the study and during the study.

info icon 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 containing these products 4 weeks prior to starting study drug.

info icon Subjects with distant metastatic cancer. Node positive prostate cancer patients are allowed after completion of treatment.

info icon Subjects who are receiving chemotherapy, or oral TKI, or immunotherapy (checkpoint inhibitor).

info icon Subjects who are receiving any other investigational agents.

info icon Uncontrolled intercurrent illness that would limit compliance with study requirements.

info icon All vulnerable patient populations.

info icon 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.

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

info icon Subjects who are taking Warfarin/Coumadin.

Recruiting status

Active Not Recruiting

Estimated enrollment

12

 
Study start date

May 02, 2023

Study end date

Sep 30, 2025

Last updated

Mar 23, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Drug

Study phase

PHASE1

Allocation

Na

 

Sponsor:

Milton S. Hershey Medical Center

Collaborator:

N/A

Investigator:

Monika Joshi, MD

NCT05375539

Clinic Location Investigator Distance RECRUITING STATUS Contact