Clinical trial NCT01446952: Vitamin E δ-Tocotrienol (VEDT) Single Dose in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Cancer
Keywords: prevention
pancreas
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: BioGene Life Science
First posted: 2011-10-05
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 3 weeks per participant
Secondary outcomes:
measure: Number of Participants With Pharmacokinetic (PK) Markers of Vitamin E δ-Tocotrienol
timeFrame: 3 weeks per participant
measure: Number of Participants With Pharmacodynamic (PD) Markers of Vitamin E δ-Tocotrienol
timeFrame: 3 weeks per participant
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Jason Klapman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: