A Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of Vitamin E δ-Tocotrienol Following Single Dose Administration in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
This is a Phase 1, open-label, non-randomized, dose-finding, study of Vitamin E δ-Tocotrienol in subjects with resectable pancreatic tumors.
详细描述
Vitamin E tocotrienols have been shown to exhibit cancer-preventive activities in preclinical studies. Vitamin E tocotrienols are composed of α-, β-, δ-, and γ-tocotrienols. The investigators preclinical studies indicate that δ-tocotrienol possesses the most potent antitumor activity against pancreatic cancer. It is believed that this micronutrient may have a role in the prevention of pancreatic cancer in healthy participants who are at increased risk of developing the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The participant is ≥ 18 years old
- •The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤
- •The participant has adequate organ function as follows:
- •Serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min.
- •Bilirubin ≤ the institutional upper limits of normal (ULN)
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) to be within institutional normal range.
- •Absolute neutrophil count (ANC) ≥ 1000mm³
- •Platelet count ≥ 100,000/mm³
- •The participant has the capability of understanding the informed consent document and has signed the informed consent document.
- •Sexually active participants (male and female) must use medically acceptable methods of contraception during the course of the study.
- •Female participants of childbearing potential must have a negative pregnancy test at screening.
- •Able to understand and comply with the requirements of the protocol.
排除标准
- •The participant is receiving investigational therapy (other than the investigational therapy under study).
- •The participant has received investigational therapy within 30 days prior to first dose of study drug.
- •Patients who are unable to swallow capsules.
- •Patients with prior malignancies, other than squamous or basal cell carcinomas, unless disease free for ≥ 5 years.
- •The participant has had prior major surgery within 30 days prior to first dose of study drug.
- •The participant has active infection or fever >38.5C within 3 days prior to first dose of study drug.
- •The participant has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •The participant is unable or unwilling to stop taking vitamins, herbal remedies, or nonprescription medications.
- •The participant is pregnant or breastfeeding.
- •The participant is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
研究组 & 干预措施
Dose Escalation
Vitamin E δ-Tocotrienol will be administered orally as a single agent once. Vitamin E δ-Tocotrienol is supplied as 100-mg, 200-mg, and 400-mg capsules.
干预措施: Vitamin E δ-Tocotrienol (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 3 weeks per participant
The primary objective of this study is to evaluate the safety and tolerability of Vitamin E δ-Tocotrienol and to determine the minimally effective dose (MED) or maximum tolerated dose (MTD) of Vitamin E δ-Tocotrienol administered once. Safety will be assessed by standard clinical findings and laboratory tests. Toxicity grade is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)v.4.0. Ninety-five percent confidence intervals may be calculated for selected safety and exploratory variables.
次要结局
- Number of Participants With Pharmacokinetic (PK) Markers of Vitamin E δ-Tocotrienol(3 weeks per participant)
- Number of Participants With Pharmacodynamic (PD) Markers of Vitamin E δ-Tocotrienol(3 weeks per participant)