A Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of Vitamin E δ-Tocotrienol Following Single Dose Administration in Healthy Subjects
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
A Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of Vitamin E δ-Tocotrienol Following Single Dose Administration in Healthy Subjects
Vitamin E tocotrienols have been shown to exhibit cancer-preventive activities in
preclinical studies. Vitamin E tocotrienols are composed of α-, β-, δ-, and γ-tocotrienols.
The investigators preclinical studies indicate that δ-tocotrienol possesses the most potent
antitumor activity against pancreatic cancer. It is believed that this micronutrient may
have a role in the prevention of pancreatic cancer in healthy participants who are at
increased risk of developing the disease.
Inclusion Criteria:
- The participant is ≥ 18 years old
- The participant has an Eastern Cooperative Oncology Group (ECOG) performance status
of ≤ 2.
- The participant has adequate organ function as follows:
- Serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min.
- Bilirubin ≤ the institutional upper limits of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) to be within
institutional normal range.
- Absolute neutrophil count (ANC) ≥ 1000mm³
- Platelet count ≥ 100,000/mm³
- The participant 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.
- Female participants of childbearing potential must have a negative pregnancy test at
screening.
- Able to understand and comply with the requirements of the protocol.
Exclusion Criteria:
- The participant is receiving investigational therapy (other than the investigational
therapy under study).
- The participant has 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.
- The participant has had prior major surgery within 30 days prior to first dose of
study drug.
- The participant has active infection or fever >38.5C within 3 days prior to first
dose of study drug.
- The participant has 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.
- The participant is unable or unwilling to stop taking vitamins, herbal remedies, or
nonprescription medications.
- The participant is pregnant or breastfeeding.
- The participant is unable or unwilling to abide by the study protocol or cooperate
fully with the investigator or designee.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Number of Participants With 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 minimally effective dose (MED) or maximum tolerated dose (MTD) of Vitamin E δ-Tocotrienol administered once. Safety will be assessed by standard clinical findings and laboratory tests. Toxicity grade is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)v.4.0. Ninety-five percent confidence intervals may be calculated for selected safety and exploratory variables.
Outcome Time Frame:
3 weeks per participant
Safety Issue:
Yes
Principal Investigator
Jason Klapman, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
H. Lee Moffitt Cancer Center and Research Institute
Authority:
United States: Food and Drug Administration
Study ID:
MCC-16152
NCT ID:
NCT01446952
Start Date:
September 2011
Completion Date:
October 2014
Related Keywords:
- Pancreatic Cancer
- prevention
- pancreas
- Pancreatic Neoplasms
Name | Location |
|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
