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A Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of Vitamin E δ-Tocotrienol Following Multiple Dose Administration in Healthy Subjects

Phase 1
18 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

A Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of Vitamin E δ-Tocotrienol Following Multiple Dose Administration in Healthy Subjects

Participants will be accrued in cohorts of three. The decision to dose escalate will be made
by the Cohort Review Committee (CRC) based on safety after the last subject in the current
cohort has completed the Study Treatment Period. The study will consist of the following

- Pre-Treatment Period: The screening period must occur within 7 days of dosing.

- Study Treatment Period (14 days): Vitamin E δ-Tocotrienol will be administered orally
twice daily for 14 consecutive days

- Post-Treatment Period: Subject will return to the study site 7 days after the dose of
Vitamin E δ-Tocotrienol for an end-of-treatment assessment. On day 8 (± 2 days) after
the last dose of study drug, the investigator will obtain follow-up information. Any
serious adverse events (SAEs) present at 7 days after the last dose and possibly
related to study drug will be followed until resolution, stabilization, or initiation
of treatment that confounds the ability to assess the event.

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

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

- 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

- Pregnant or breastfeeding

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Number of Participants With Treatment Related Adverse Events

Outcome Description:

The primary objective of this study is to evaluate the safety and tolerability of Vitamin E δ-Tocotrienol and to determine the maximum administered dose (MAD) or maximum tolerated dose (MTD) of Vitamin E δ-Tocotrienol administered twice daily for 14 days. Safety analyses and summary tables will include data collected for all subjects who receive at least one dose of study drug.

Outcome Time Frame:

3 Weeks Per Participant

Safety Issue:


Principal Investigator

Shivakumar Vignesh, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

October 2011

Completion Date:

November 2014

Related Keywords:

  • Pancreatic Cancer
  • pancreas
  • gastrointestinal
  • GI
  • prevention
  • vitamin E
  • Pancreatic Neoplasms



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612