Vitamin E δ-Tocotrienol Multiple Dose in Healthy Subjects

NCT01450046 | Completed Phase 1 DMC

• 1 other identifier: MCC-16153
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

pancreas; gastrointestinal; GI; prevention; vitamin E

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Related Adverse Events

  The primary objective of this study is to evaluate the safety and tolerability of Vitamin E δ-Tocotrienol and to determine the maximum administered dose (MAD) or maximum tolerated dose (MTD) of Vitamin E δ-Tocotrienol administered twice daily for 14 days. Safety analyses and summary tables will include data collected for all subjects who receive at least one dose of study drug.

  3 Weeks Per Participant

Secondary Outcomes (2)

• Maximum Plasma Concentration (Cmax) of Vitamin E δ-Tocotrienol

  3 Weeks Per Participant

• Pharmacodynamic (PD) Markers of Vitamin E δ-Tocotrienol Activity in Peripheral Blood

  Day 1, Day 8 Day 14

Study Arms (1)

Phase I Dose Escalation

EXPERIMENTAL

Each investigator will be provided with adequate supplies of Vitamin E δ -Tocotrienol, which will be supplied as 100-mg, 200-mg, and 400-mg capsules. Vitamin E δ-Tocotrienol will be administered orally once. The dose administered to each subject will be fixed and based on cohort assignment. Doses will be administered at the clinical site during each protocol-defined visit.

Drug: Vitamin E δ-Tocotrienol

Interventions

Vitamin E δ-Tocotrienol DRUG

Vitamin E δ-Tocotrienol will be administered orally as a single agent twice daily for 14 consecutive days. Vitamin E δ-Tocotrienol is supplied as 100-mg, 200-mg, and 400-mg capsules. The first cohort will be dosed with δ-tocotrienol at 100 mg twice daily for 14 consecutive days. A minimum of 3 subjects is planned for each dosing cohort with Vitamin E δ-Tocotrienol dose escalation dependent on safety and available PK data from prior cohorts. At the MTD or MAD, 18 subjects will be enrolled.

Also known as: Delta-tocotrienol

Phase I Dose Escalation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

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: October 7, 2011
• First Posted: October 12, 2011
• Study Start: October 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2016
• Last Updated: July 7, 2016

Record last verified: 2016-07

Locations

US (1)