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

Completed · Phase 1

Conditions studied: Pancreatic Cancer

In brief

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

Key facts

Study ID

NCT01446952

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

18

Starts

2011-09-01

Expected to finish

2016-04-01

Last updated by the study team

2016-04-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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