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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
18
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.
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
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.
Time frame: 3 weeks per participant
Number of Participants With Pharmacokinetic (PK) Markers of Vitamin E δ-Tocotrienol
Pharmacokinetic (PK) markers of Vitamin E δ-Tocotrienol in the plasma, urine, and neoplastic tissue of participants with pancreatic neoplasia. To determine the effects of dose on the plasma pharmacokinetic (PK) of Vitamin E δ-Tocotrienol when orally administered as a single dose in healthy subjects. Ninety-five percent confidence intervals may be calculated for selected safety and exploratory variables. Dose escalation will be based on safety and available PK data.
Time frame: 3 weeks per participant
Number of Participants With Pharmacodynamic (PD) Markers of Vitamin E δ-Tocotrienol
Pharmacodynamic (PD) Markers of Vitamin E δ-Tocotrienol in the plasma, urine, and neoplastic tissue of participants with pancreatic neoplasia. To evaluate pharmacodynamic (PD) markers of Vitamin E δ-Tocotrienol activity in peripheral blood. Ninety-five percent confidence intervals may be calculated for selected safety and exploratory variables. Correlative analysis of PD data will be done.
Time frame: 3 weeks per participant
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