drugset / Trial / NCT00102635
4-HPR and FTI in Head and Neck Squamous Cell Carcinoma (HNSCC)
Phase 1
Terminated
1 enrolled
M.D. Anderson Cancer Center
National Cancer Institute (NCI) · collabSchering-Plough · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this study is to estimate the modulation of intermediate biological endpoints of the combination of 4-HPR and SCH66336, a farnesyl transferase inhibitor (FTI), across 4 randomly assigned dose levels in patients with locally advanced or recurrent head and neck cancer. We will also assess the activity, safety, tolerability and side effects of 4-HPR/SCH66336 and hope to establish a phase II regimen.
Timeline
- Start
- 2005-01-20
- Primary completion
- 2006-01
- Completion
- 2006-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lonafarnib | Small molecule | 50 mg | Oral |
| Subject | Lonafarnib | Small molecule | 75 mg | Oral |
| Subject | Lonafarnib | Small molecule | 100 mg | Oral |
| Subject | fenretinide | Small molecule | 100 mg | Oral |