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
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
Maximum Tolerated Dose (MTD)
To determine the recommended Phase II dose of Vitamin E δ-Tocotrienol which will be defined as the biologic effective dose (BED) which induces significant apoptosis in the pancreatic neoplastic cells of resected tumor specimens following oral administration of Vitamin E δ-Tocotrienol twice daily for 14 (± 2)days prior to surgery, and one dose the day of surgery.
12 weeks per participant
Gregory Springett, M.D., Ph.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|