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NCT01116336 · ClinicalTrials.gov registry record · Phase 1
Phase I Chemoprevention Trial With Green Tea Polyphenon E & Erlotinib in Patients With Premalignant Lesions of the Head & Neck
A Phase 1 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT01116336 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 25 participants.
The verdict
NCT01116336, a Phase 1 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
The purpose of this study is to test the preventive effects of a combination of drugs: polyphenon E (PPE) derived from green tea extracts, and erlotinib. Because this combination of drugs has not been tested in humans before for the prevention of cancer, it is not clear which dose of each agent will be optimal in combination. We will test the safety of the combination of PPE and erlotinib and see what effects (good and/or bad) it has on the patient's premalignant lesion, and find the highest dose of each agent that can be given in combination without causing severe side effects.
Interventions
- DRUG Erlotinib
- DIETARY_SUPPLEMENT Green Tea Polyphenon E
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2010-03 |
| Est. Completion | 2018-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01116336
The ClinicalTrials.gov registry entry for NCT01116336 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Erlotinib is the first listed.
NCT01116336 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01116336 about?
NCT01116336 is a clinical study titled "Phase I Chemoprevention Trial With Green Tea Polyphenon E & Erlotinib in Patients With Premalignant Lesions of the Head & Neck". The purpose of this study is to test the preventive effects of a combination of drugs: polyphenon E (PPE) derived from green tea extracts, and erlotinib. Because this combination of drugs has not been tested in humans before for the prevention of cancer, it is not clear which dose of each agent will...
What is the current status of trial NCT01116336?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2010-03. Estimated completion is 2018-05.
What interventions are being tested in trial NCT01116336?
The interventions under investigation include: Erlotinib (DRUG), Green Tea Polyphenon E (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01116336?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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