A Phase 1 interventional study of Vitamin E δ-Tocotrienol in Pancreatic Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-11.
Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Phase 1, Interventional, and Prevention
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.
H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
The participant has adequate organ function as follows:
Exclusion Criteria:
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.
Drug: Vitamin E δ-Tocotrienol
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.
Also known as: Delta-tocotrienol
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
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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H. Lee Moffitt Cancer Center and Research Institute