Clinical trial · Interventional
Vitamin E δ-Tocotrienol (VEDT) Single Dose in Healthy Subjects
A Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of Vitamin E δ-Tocotrienol Following Single Dose Administration in Healthy Subjects
NCT01446952CI-TRIAL-00021703completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase 1, open-label, non-randomized, dose-finding, study of Vitamin E δ-Tocotrienol in subjects with resectable pancreatic tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vitamin E δ-Tocotrienol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- Vitamin E δ-Tocotrienol will be administered orally as a single agent once. Vitamin E δ-Tocotrienol is supplied as 100-mg, 200-mg, and 400-mg capsules.
- interventionNames
- Drug: Vitamin E δ-Tocotrienol
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events
- timeFrame
- 3 weeks per participant
- description
- The primary objective of this study is to evaluate the safety and tolerability of Vitamin E δ-Tocotrienol and to determine the minimally effective dose (MED) or maximum tolerated dose (MTD) of Vitamin E δ-Tocotrienol administered once. Safety will be assessed by standard clinical findings and laboratory tests. Toxicity grade is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)v.4.0. Ninety-five percent confidence intervals may be calculated for selected safety and exploratory variables.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The participant is ≥ 18 years old * The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. * The participant has adequate organ function as follows: * Serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min. * Bilirubin ≤ the institutional upper limits of normal (ULN) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) to be within institutional normal range. * Absolute neutrophil count (ANC) ≥ 1000mm³ * Platelet count ≥ 100,000/mm³ * The participant 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. * Female participants of childbearing potential must have a negative pregnancy test at screening. * Able to understand and comply with the requirements of the protocol. Exclusion Criteria: * The participant is receiving investigational therapy (other than the investigational therapy under study). * The participant has 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. * The participant has had prior major surgery within 30 days prior to first dose of study drug. * The participant has active infection or fever \>38.5C within 3 days prior to first dose of study drug. * The participant has 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. * The participant is unable or unwilling to stop taking vitamins, herbal remedies, or nonprescription medications. * The participant is pregnant or breastfeeding. * The participant is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
References
Publications (0)
Data not yet available
No reference posted for this study.