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NCT01450046 · ClinicalTrials.gov registry record · Phase 1
Vitamin E δ-Tocotrienol Multiple Dose in Healthy Subjects
A Phase 1 study of Pancreatic Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT01450046: Completed Phase 1 study of Pancreatic Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01450046 is a Phase 1 study of Pancreatic Cancer that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 18 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01450046, a Phase 1 study of Pancreatic Cancer, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study 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 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.
Primary Outcome
The primary objective of this study is to evaluate the safety and tolerability of Vitamin E δ-Tocotrienol and to determine the maximum administered dose (MAD) or maximum tolerated dose (MTD) of Vitamin E δ-Tocotrienol administered twice daily for 14 days. Safety analyses and summary tables will include data collected for all subjects who receive at least one dose of study drug.
Conditions Studied
Interventions
- DRUG Vitamin E δ-Tocotrienol
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-10 |
| Est. Completion | 2016-04 |
| Phase | Phase 1 |
What the finished NCT01450046 record still lists
NCT01450046 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 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Pancreatic Cancer appearing as the primary indexed condition, and to 1 intervention - of which Vitamin E δ-Tocotrienol is the first listed.
NCT01450046 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01450046 about?
NCT01450046 is a clinical study titled "Vitamin E δ-Tocotrienol Multiple Dose in Healthy Subjects". 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...
What is the current status of trial NCT01450046?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2011-10. Estimated completion is 2016-04.
What conditions does trial NCT01450046 study?
This clinical trial studies the following conditions: Pancreatic Cancer.
What interventions are being tested in trial NCT01450046?
The interventions under investigation include: Vitamin E δ-Tocotrienol (DRUG).
Who is sponsoring clinical trial NCT01450046?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01450046 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01450046's enrollment target sits among peer trials
18 235th of 278 higher than 38 of 278 other Pancreatic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Cancer 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.
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