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Vitamin E δ-Tocotrienol (VEDT) Single Dose in Healthy Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT01446952•H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.
+2 more criteria

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.

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Key Dates

Start Date

September 1, 2011

Primary Completion Date

September 1, 2012

Completion Date

April 1, 2016

Last Updated

April 11, 2016

Enrollment

ACTUAL participants

Conditions

Pancreatic Cancer

Interventions

Vitamin E δ-Tocotrienol

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 11, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

Resilience and Equity in Aging, Cancer, and Health (REACH)

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients