Vitamin E δ-Tocotrienol Multiple Dose in Healthy Subjects

Completed · Phase 1

Conditions studied: Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT01450046

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

18

Starts

2011-10-01

Expected to finish

2016-04-01

Last updated by the study team

2016-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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