drugset / Trial / NCT00996515
A Phase 1 Protocol of 5-Azacytidine and Erlotinib in Advanced Solid Tumor Malignancies
Non-randomizedSingle-groupOpen-labelTreatment
Summary
PRIMARY OBJECTIVES: I. To document the toxicities, and reversibility of toxicities, of this regimen of 5-azacytidine (azacitidine) and erlotinib (erlotinib hydrochloride). SECONDARY OBJECTIVES: I. To determine any potential anti-tumor effects, as determined by the objective tumor response (complete and partial responses), clinical benefit (complete and partial responses, and clinical benefit), the time to tumor response, the time to tumor progression, and the overall survival.
Timeline
- Start
- 2008-06
- Primary completion
- 2011-07
- Completion
- 2011-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 5-Azacytidine | Small molecule | 75 mg/m2 | Intravenous |
| Subject | 5-Azacytidine | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Erlotinib | Small molecule | 150 mg | Oral |
| Subject | Erlotinib | Small molecule | 200 mg | Oral |