Clinical trial NCT01450046: Vitamin E δ-Tocotrienol Multiple Dose in Healthy Subjects
Official title: A Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of Vitamin E δ-Tocotrienol Following Multiple Dose Administration in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Cancer
Keywords: pancreas
gastrointestinal
GI
prevention
vitamin E
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: 2011-10-12
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: The Principal Investigator believes that Vitamin E δ-Tocotrienol will slow the progression of pancreatic cancer cells. Therefore, the investigators must determine the safety and tolerability of Vitamin E δ-Tocotrienol in healthy participants before administering to cancer patients. The investigators will do this by giving participants a dose of up to1600 mg twice a day, not to exceed 3200 mg total for 14 consecutive days.

Detailed description: Participants will be accrued in cohorts of three. The decision to dose escalate will be made by the Cohort Review Committee (CRC) based on safety after the last subject in the current cohort has completed the Study Treatment Period. The study will consist of the following procedures:

* Pre-Treatment Period: The screening period must occur within 7 days of dosing.
* Study Treatment Period (14 days): Vitamin E δ-Tocotrienol will be administered orally twice daily for 14 consecutive days
* Post-Treatment Period: Subject will return to the study site 7 days after the dose of Vitamin E δ-Tocotrienol for an end-of-treatment assessment. On day 8 (± 2 days) after the last dose of study drug, the investigator will obtain follow-up information. Any serious adverse events (SAEs) present at 7 days after the last dose and possibly related to study drug will be followed until resolution, stabilization, or initiation of treatment that confounds the ability to assess the event.

Eligibility criteria: Inclusion Criteria:

* Equal to or greater than 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
* Adequate organ function:

  * Serum creatinine ≤1.5 mg/dL or calculated creatinine clearance ≥60 mL/min.
  * Bilirubin ≤ the intuitional upper limits of normal
  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) to be within institutional normal range
  * Absolute neutrophil count (ANC) ≥1000mm³
  * Platelet count ≥100,000mm³
* 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.
* Women of childbearing potential must have a negative pregnancy test at screening.
* Able to understand and comply with the requirements of the protocol

Exclusion Criteria:

* receiving investigational therapy (other than the investigational therapy under study)
* Have 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
* Have had prior major surgery within 30 days prior to first dose of study drug
* The patient has active infection or fever \>38.5C within 3 days prior to first dose of study drug.
* Have 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
* Unable or unwilling to stop taking vitamins, herbal remedies, or nonprescription medications
* Pregnant or breastfeeding
* Unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee

Primary outcomes:
measure: Number of Participants With Treatment Related Adverse Events
timeFrame: 3 Weeks Per Participant
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax) of Vitamin E δ-Tocotrienol
timeFrame: 3 Weeks Per Participant
measure: Pharmacodynamic (PD) Markers of Vitamin E δ-Tocotrienol Activity in Peripheral Blood
timeFrame: Day 1, Day 8 Day 14
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: