Status:
COMPLETED
Vitamin E δ-Tocotrienol (VEDT) Single Dose in Healthy Subjects
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
BioGene Life Science
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 preclini...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01446952
Start Date
September 1 2011
End Date
April 1 2016
Last Update
April 11 2016
Active Locations (1)
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1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612