Angelica Herbal Supplement AGN-Cogni.Q Acute Dose Safety and Pharmacokinetics (PK) Dose-Response in Prostate Cancer Patients (PK Dose Trial)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Safety blood lab tests
研究概览
简要总结
This study is to obtain acute dose safety and pharmacokinetics/pharmacodynamics (PK/PD) data in a dose-response trial in prostate cancer patients.
详细描述
The long-term goal of the study is to conduct human clinical trials to test Angelica gigas Nakai (AGN) root alcoholic extract herbal supplement product (AGN-Cogni.Q, or Cogni.QTM, made with INM®176 proprietary ingredient, Quality of Life Laboratories, Purchase, NY) as a safe and potential efficacious modality for prostate cancer interception akin to secondary prevention to delay hormonal therapy or avoid it entirely after patients have developed recurrent disease following their standard of care (SOC) surgery and radiation curative treatment. The acute dose safety and pharmacokinetics (PK) and pharmacodynamics (PD) information in the target patient population from the current proposed acute PK dose-response trial will inform the optimal design and execution of the longer-term safety and efficacy (phase I/II) trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Willingness and ability to give informed consent.
- •Agree to comply with all study procedures and attend all study visits to the best of their ability.
- •Male with age >=40 years.
- •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:
- •Patients treated forprostate cancer and no detectable disease on imaging and clinical determination are eligible for enrollment, regardless of risk category.
- •Patients in the low-risk and favorable intermediate-risk groups who are not currently receiving any treatment or have declined any treatment.
- •Not on concurrent androgen deprivation therapy.
- •ECOG performance status 0-
- •Life expectancy of greater than 12 months.
- •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.
- •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.
- •Subjects must stop the CYP3A4 and CYP2C19 strong inhibitors or inducers 2 weeks prior to the start of the study and during the study.
- •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.
排除标准
- •Subjects with distant metastatic cancer. Node positive prostate cancer patients are allowed after completion of treatment.
- •Subjects who are receiving chemotherapy, or oral TKI, or immunotherapy (checkpoint inhibitor).
- •Subjects who are receiving any other investigational agents.
- •Uncontrolled intercurrent illness that would limit compliance with study requirements.
- •All vulnerable patient populations.
- •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.
- •Use of androgen deprivation therapy (ADT) or anti-androgen therapy including LHRH agonist, antagonist, GNRH analogs, and antiandrogens.
- •Subjects who are taking Warfarin/Coumadin.
研究组 & 干预措施
AGN-Cogni.Q
Dose level +1 (800 mg, 4 Cogni.Q capsules, Fast at least 2 h before dose and 1 h after) Dose level +2 (1,200 mg, 6 Cogni.Q capsules, Fast at least 2 h before dose and 1 h after) Dose level +3 (1,600 mg, 8 Cogni.Q capsules, Fast at least 2 h before dose and 1 h after)
干预措施: AGN-Cogni.Q (Drug)
结局指标
主要结局
Safety blood lab tests
时间窗: 5-6 weeks
CBC diff for hematological safety and CMP for liver and kidney safety at baseline and 24 +/- 2 h after dose and before the next dose level (the latter also serves as baseline for the next dose).
Electrocardiography (EKG) QTC Interval
时间窗: 5-6 weeks
Cardiac safety measured by EKG QT Interval at baseline, at 5 hours (+/-60mins) and 24 h (+/-2hrs) after study drug treatment every study visit (usually weekly) up to 5 weeks
Cardiac Safety Via Electrocardiography (EKG)
时间窗: Baseline (pre-dose) and 5 hours post-dose on each dosing day and at 24 hours (Up to 5 weeks).
Evaluation of cardiac rhythm and repolarization using 12-lead EKG to identify any treatment-emergent abnormalities. Unit of Measure: Number of participants with treatment-emergent EKG abnormalities.
Safety Blood Laboratory Tests
时间窗: 24 hours post-dose and prior to each subsequent dose level (Up to 5 weeks).
Evaluation of hematological and metabolic safety via Complete Blood Count (CBC) with differential, Comprehensive Metabolic Panel (CMP), and coagulation tests (INR, PT, PTT) to identify any treatment-emergent abnormalities.
次要结局
- Peak Plasma Concentration (Cmax)(4-6 weeks)
- Plasma Concentration versus time curve (AUC)(4-6 weeks)
- Pharmacokinetics: Peak Plasma Concentration (Cmax) of D, DA, and DOH(0 to 24 hours post-dose for each dosing visit (Up to 5 weeks))
- Plasma Concentration Versus Time Curve (AUC)(0 to 24 hours post-dose for each dosing visit (Up to 5 weeks))
- Change From Baseline in NK, CD4+ T, and CD8+ T Cell Percentages at 24 Hours.(Baseline (0 hours) and Day 2 (24 hours post-dose).)
- Body Temperature Measurements From Baseline Through 24 Hours Post-dose(Baseline (0 hours) and 24 hours post-dose.)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(From first dose of study drug to 4 weeks (± 7 days) following the last dose.)
研究者
Junxuan Lu
Professor
Milton S. Hershey Medical Center