A Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of Vitamin E δ-Tocotrienol Following Single Dose Administration in Healthy Subjects
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Number of Participants With Adverse Events
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.
3 weeks per participant
Jason Klapman, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|