Status:
COMPLETED
Vitamin E δ-Tocotrienol Multiple Dose in Healthy Subjects
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
BioGene Life Science
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 Vitami...
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 compl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01450046
Start Date
October 1 2011
End Date
April 1 2016
Last Update
July 7 2016
Active Locations (1)
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1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612