Status and phase
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About
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.
Full 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:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Equal to or greater than 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
Adequate organ function:
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
Primary purpose
Allocation
Interventional model
Masking
18 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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