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NCT01446952 · ClinicalTrials.gov registry record · Phase 1
Vitamin E δ-Tocotrienol (VEDT) Single Dose in Healthy Subjects
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01446952: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01446952 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01446952, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This is a Phase 1, open-label, non-randomized, dose-finding, study of Vitamin E δ-Tocotrienol in subjects with resectable pancreatic tumors.
Primary Outcome
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 selec
Interventions
- DRUG Vitamin E δ-Tocotrienol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-09 |
| Est. Completion | 2016-04 |
| Phase | Phase 1 |
What the finished NCT01446952 record still lists
NCT01446952 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which Vitamin E δ-Tocotrienol is the first listed.
NCT01446952 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01446952 about?
NCT01446952 is a clinical study titled "Vitamin E δ-Tocotrienol (VEDT) Single Dose in Healthy Subjects". This is a Phase 1, open-label, non-randomized, dose-finding, study of Vitamin E δ-Tocotrienol in subjects with resectable pancreatic tumors.
What is the current status of trial NCT01446952?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2011-09. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01446952?
The interventions under investigation include: Vitamin E δ-Tocotrienol (DRUG).
Who is sponsoring clinical trial NCT01446952?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01446952's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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