Vitamin E δ-Tocotrienol (VEDT) Single Dose in Healthy Subjects
A Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of Vitamin E δ-Tocotrienol Following Single Dose Administration in Healthy Subjects
This is a Phase 1, open-label, non-randomized, dose-finding, study of Vitamin E δ-Tocotrienol in subjects with resectable pancreatic tumors.
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.
The first cohort will be dosed with δ-tocotrienol at 200 mg. A minimum of 3 participants is planned for each dosing cohort with Vitamin E δ-Tocotrienol dose escalation dependent on safety from prior cohorts.
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.
Inclusion Criteria: The participant is ≥ 18 years old The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. 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. Exclusion Criteria: 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.