drugset / Trial / NCT00444015
Phase I Dasatinib/Erlotinib in Recurrent Non-small Cell Lung Cancer (NSCLC)
Phase 1
Completed
34 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Bristol-Myers Squibb · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a single site phase I dose escalation trial of the epidermal growth factor receptor inhibitor Erlotinib with the SRC tyrosine kinase inhibitor Dasatinib in patients with previously treated advanced stage (Stage IIIB/IV disease) Non-Small Cell Lung Cancer (NSCLC). The treatment regimen consists of Erlotinib tablets starting Day 1 and Dasatinib tablets starting Day 9 for a 28-day cycle. If there are no Dose Limiting Toxicities (DLTs), dose escalation continues. The recommended phase II dose for this combined treatment will be defined and patients will be treated at the recommended phase II dose to confirm tolerability.
Timeline
- Start
- 2007-03
- Primary completion
- 2010-08
- Completion
- 2010-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Erlotinib | Small molecule | — | Oral |
| Subject | dasatinib anhydrous | Small molecule | — | Oral |