drugset / Trial / NCT01116622
Erlotinib (Tarceva) and Bexarotene (Targretin) Oral Capsules in Advanced Cancers of the Aerodigestive Tract
Phase 1
Completed
24 enrolled
Dartmouth-Hitchcock Medical Center
Genentech, Inc. · collabLigand Pharmaceuticals · collab
NaSingle-groupOpen-labelTreatment
Summary
Primary objective: To determine the Phase II doses and to evaluate the safety of administering bexarotene (Targretin®) daily in combination with oral erlotinib (Tarceva™) to patients with advanced aerodigestive tract cancers. Secondary objectives: To evaluate the response rates, progression-free survival and overall survival of patients with advanced aerodigestive tract cancers treated with bexarotene (Targretin®) in combination with erlotinib (Tarceva™). To investigate the activity of this targeted combination therapy by evaluating changes in molecular markers from pre- and post-treatment buccal swab samples.
Timeline
- Start
- 2003-04
- Primary completion
- 2014-04
- Completion
- 2014-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bexarotene | Small molecule | 200 mg/m2 | Oral |
| Subject | Bexarotene | Small molecule | 300 mg/m2 | Oral |
| Subject | Bexarotene | Small molecule | 400 mg/m2 | Oral |
| Subject | Erlotinib | Small molecule | 100 mg | Oral |
| Subject | Erlotinib | Small molecule | 150 mg | Oral |