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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01446952
Recruitment Status : Completed
First Posted : October 5, 2011
Last Update Posted : April 11, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
BioGene Life Science
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Tracking Information
First Submitted Date  ICMJE September 28, 2011
First Posted Date  ICMJE October 5, 2011
Last Update Posted Date April 11, 2016
Study Start Date  ICMJE September 2011
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2011)
Number of Participants With Adverse Events [ Time Frame: 3 weeks per participant ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2011)
  • Number of Participants With Pharmacokinetic (PK) Markers of Vitamin E δ-Tocotrienol [ Time Frame: 3 weeks per participant ]
    Pharmacokinetic (PK) markers of Vitamin E δ-Tocotrienol in the plasma, urine, and neoplastic tissue of participants with pancreatic neoplasia. To determine the effects of dose on the plasma pharmacokinetic (PK) of Vitamin E δ-Tocotrienol when orally administered as a single dose in healthy subjects. Ninety-five percent confidence intervals may be calculated for selected safety and exploratory variables. Dose escalation will be based on safety and available PK data.
  • Number of Participants With Pharmacodynamic (PD) Markers of Vitamin E δ-Tocotrienol [ Time Frame: 3 weeks per participant ]
    Pharmacodynamic (PD) Markers of Vitamin E δ-Tocotrienol in the plasma, urine, and neoplastic tissue of participants with pancreatic neoplasia. To evaluate pharmacodynamic (PD) markers of Vitamin E δ-Tocotrienol activity in peripheral blood. Ninety-five percent confidence intervals may be calculated for selected safety and exploratory variables. Correlative analysis of PD data will be done.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin E δ-Tocotrienol (VEDT) Single Dose in Healthy Subjects
Official Title  ICMJE A Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of Vitamin E δ-Tocotrienol Following Single Dose Administration in Healthy Subjects
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE Drug: 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.
Other Name: Delta-tocotrienol
Study Arms  ICMJE Experimental: 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.
Intervention: Drug: Vitamin E δ-Tocotrienol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2013)
18
Original Estimated Enrollment  ICMJE
 (submitted: October 4, 2011)
42
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01446952
Other Study ID Numbers  ICMJE MCC-16152
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lee Moffitt Cancer Center and Research Institute
Study Sponsor  ICMJE H. Lee Moffitt Cancer Center and Research Institute
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • BioGene Life Science
Investigators  ICMJE
Principal Investigator: Jason Klapman, M.D. H. Lee Moffitt Cancer Center and Research Institute
PRS Account H. Lee Moffitt Cancer Center and Research Institute
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP