drugset / Trial / NCT01116336
Phase I Chemoprevention Trial With Green Tea Polyphenon E & Erlotinib in Patients With Premalignant Lesions of the Head & Neck
Phase 1
Completed
25 enrolled
Emory University
Astellas Pharma Inc · collabNational Cancer Institute (NCI) · collabPolyphenon Pharma · collab
NaSingle-groupOpen-labelPrevention
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.
Timeline
- Start
- 2010-03
- Primary completion
- 2018-05
- Completion
- 2018-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Erlotinib | Small molecule | 50 mg | Oral |
| Subject | Erlotinib | Small molecule | 75 mg | Oral |
| Subject | Erlotinib | Small molecule | 100 mg | Oral |