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

Gregory Springett, M.D., Ph.D.H., Moffitt Cancer Center (USA)

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

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 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.

Secondary Outcome: To characterize the safety and tolerability of Vitamin E δ-Tocotrienol when orally administered at up to 5.6 times the predicted biological effective dose (1600mg twice daily) for 14 (± 2) consecutive days and one dose the day of surgery in patients with pancreatic neoplasia.

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.

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