Pancreatic Neoplasms Clinical Trial
Official title:
A Phase I Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Vitamin E δ-Tocotrienol Administered to Subjects With Resectable Pancreatic Exocrine Neoplasia
The purpose of this study is to determine the safest dose of the study drug Vitamin E Delta-tocotrienol, how often it should be taken, and how well people with pancreatic tumors tolerate Vitamin E Delta-tocotrienol.
Delta-tocotrienol is a natural Vitamin E compound that has been consumed by humans as a
dietary supplement. The Food and Drug Administration (FDA) has not approved it for sale as a
drug. Vitamin E Delta-tocotrienol is being investigated for the prevention and treatment of
pancreatic tumors. The usefulness of the Vitamin E Delta-tocotrienol in treating human
tumors is unknown.
This study consists of the following: (1) a Pre-Treatment Period in which participants are
consented and qualified for the study; (2) a Study Treatment Period in which participant
will receive Vitamin E δ-Tocotrienol administered orally twice daily for 14 (±2) consecutive
days and once on the day of surgery, with associated pharmacokinetic and pharmacodynamic
sampling; (3) a Post Treatment Period in which laboratory and physical examinations are
performed. Adverse events will be recorded throughout the study.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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