Vitamin E δ-Tocotrienol Multiple Dose in Healthy Subjects

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The Principal Investigator believes that Vitamin E δ-Tocotrienol will slow the progression of pancreatic cancer cells. Therefore, the investigators must determine the safety and tolerability of Vitamin E δ-Tocotrienol in healthy participants before administering to cancer patients. The investigators will do this by giving participants a dose of up to1600 mg twice a day, not to exceed 3200 mg total for 14 consecutive days.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: BioGene Life Science; National Cancer Institute (NCI)
• Treatments: alpha-Tocopherol; Tocopherols; Tocotrienols; Vitamin E; Vitamins

Criteria

Inclusion Criteria:

• Equal to or greater than 18 years of age

• Eastern Cooperative Oncology Group (ECOG) performance status of ≤2

• Adequate organ function:

• Serum creatinine ≤1.5 mg/dL or calculated creatinine clearance ≥60 mL/min.

• Bilirubin ≤ the intuitional upper limits of normal

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) to be within institutional normal range

• Absolute neutrophil count (ANC) ≥1000mm³

• Platelet count ≥100,000mm³

• Has the capability of understanding the informed consent document and has signed the informed consent document

• Sexually active participants (male and female) must use medically acceptable methods of contraception during the course of the study.

• Women of childbearing potential must have a negative pregnancy test at screening.

• Able to understand and comply with the requirements of the protocol

Exclusion Criteria:

• receiving investigational therapy (other than the investigational therapy under study)

• Have received investigational therapy within 30 days prior to first dose of study drug

• Patients who are unable to swallow capsules

• Patients with prior malignancies, other than squamous or basal cell carcinomas, unless disease free for ≥ 5 years

• Have had prior major surgery within 30 days prior to first dose of study drug

• The patient has active infection or fever >38.5C within 3 days prior to first dose of study drug.

• Have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Unable or unwilling to stop taking vitamins, herbal remedies, or nonprescription medications

• Pregnant or breastfeeding

• Unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee