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NCT00985777 · ClinicalTrials.gov registry record · Phase 1

Vitamin E δ-Tocotrienol Administered to Subjects With Resectable Pancreatic Exocrine Neoplasia

A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Completed
Registry status
Phase 1
Development phase
26
Enrollment target

NCT00985777: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

NCT00985777 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00985777, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

COMPLETED
Registry status
Phase 1
Development phase
26 participants
Enrollment target

Study Summary

The purpose of this study is to determine the safest dose of the study drug Vitamin E Delta-tocotrienol, how often it should be taken, and how well people with pancreatic tumors tolerate Vitamin E Delta-tocotrienol.

Primary Outcome

To determine the recommended Phase II dose of Vitamin E δ-Tocotrienol which will be defined as the biologic effective dose (BED) which induces significant apoptosis in the pancreatic neoplastic cells of resected tumor specimens following oral administration of Vitamin E δ-Tocotrienol twice daily for 14 (± 2)days prior to surgery, and one dose the day of surgery.

Interventions

  • DRUG Vitamin E δ-Tocotrienol

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2009-09
Est. Completion 2016-02
Phase Phase 1

What the finished NCT00985777 record still lists

NCT00985777 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).

The record links to 0 conditions, and to 1 intervention - of which Vitamin E δ-Tocotrienol is the first listed.

NCT00985777 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00985777 about?

NCT00985777 is a clinical study titled "Vitamin E δ-Tocotrienol Administered to Subjects With Resectable Pancreatic Exocrine Neoplasia". The purpose of this study is to determine the safest dose of the study drug Vitamin E Delta-tocotrienol, how often it should be taken, and how well people with pancreatic tumors tolerate Vitamin E Delta-tocotrienol.

What is the current status of trial NCT00985777?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2009-09. Estimated completion is 2016-02.

What interventions are being tested in trial NCT00985777?

The interventions under investigation include: Vitamin E δ-Tocotrienol (DRUG).

Who is sponsoring clinical trial NCT00985777?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00985777's enrollment target sits among peer trials

26 1482nd of 2000 higher than 506 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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Source: ClinicalTrials.gov NCT00985777, the US trial registry maintained by the National Library of Medicine. NCT00985777 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.