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.
Interventional
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
No
Gregory Springett, M.D., Ph.D.
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
MCC-15630
NCT00985777
September 2009
December 2013
Name | Location |
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H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |