Ongoing
Objective: 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.
Study Type: Interventional
Study Design: Open Label, Safety Efficacy Study
Subjects: Patients with resectable pancreatic neoplasia
Intervention: Vitamin E delta-tocotrienol (Davos Life Science Pte Ltd)
Primary Outcome:
- 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
Secondary Outcome:
- To characterize the safety and tolerability of Vitamin E δ-Tocotrienol
Methodology: 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.