Vitamin E δ-Tocotrienol (VEDT) Single Dose in Healthy Subjects

NCT ID: NCT01446952

Last Updated: 2016-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2016-04-30

Brief Summary

This is a Phase 1, open-label, non-randomized, dose-finding, study of Vitamin E δ-Tocotrienol in subjects with resectable pancreatic tumors.

Detailed Description

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Dose Escalation

Vitamin E δ-Tocotrienol will be administered orally as a single agent once. Vitamin E δ-Tocotrienol is supplied as 100-mg, 200-mg, and 400-mg capsules.

Group Type: EXPERIMENTAL

Vitamin E δ-Tocotrienol

Intervention Type: DRUG

The first cohort will be dosed with δ-tocotrienol at 200 mg. A minimum of 3 participants is planned for each dosing cohort with Vitamin E δ-Tocotrienol dose escalation dependent on safety from prior cohorts.

Interventions

Vitamin E δ-Tocotrienol

The first cohort will be dosed with δ-tocotrienol at 200 mg. A minimum of 3 participants is planned for each dosing cohort with Vitamin E δ-Tocotrienol dose escalation dependent on safety from prior cohorts.

Intervention Type: DRUG

Other Intervention Names

Delta-tocotrienol

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

BioGene Life Science

INDUSTRY

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Klapman, M.D.

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Countries

United States

Other Identifiers

MCC-16152

Identifier Type: -

Identifier Source: org_study_id