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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
BioGene Life Science
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01446952
First received: September 28, 2011
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Pancreatic Cancer
Drug: Vitamin E δ-Tocotrienol
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of Vitamin E δ-Tocotrienol Following Single Dose Administration in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: 3 weeks per participant ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Number of Participants With Pharmacokinetic (PK) Markers of Vitamin E δ-Tocotrienol [ Time Frame: 3 weeks per participant ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 18
Study Start Date: September 2011
Estimated Study Completion Date: November 2014
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446952

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
BioGene Life Science
Investigators
Principal Investigator: Jason Klapman, M.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01446952     History of Changes
Other Study ID Numbers: MCC-16152
Study First Received: September 28, 2011
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
prevention
pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 27, 2014