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

NCT01446952 | Completed Phase 1 DMC

• 1 other identifier: MCC-16152
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

prevention; pancreas

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  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.

  3 weeks per participant

Secondary Outcomes (2)

• Number of Participants With Pharmacokinetic (PK) Markers of Vitamin E δ-Tocotrienol

  3 weeks per participant

• Number of Participants With Pharmacodynamic (PD) Markers of Vitamin E δ-Tocotrienol

  3 weeks per participant

Study Arms (1)

Dose Escalation

EXPERIMENTAL

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

Interventions

Vitamin E δ-Tocotrienol DRUG

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.

Also known as: Delta-tocotrienol

Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Cancer Institute (NCI): collaborator
• BioGene Life Science: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

tocotrienol, delta

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Jason Klapman, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2011
• First Posted: October 5, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: April 1, 2016
• Last Updated: April 11, 2016

Record last verified: 2016-04

Locations

US (1)