drugset / Trial / NCT02127372
Maximum Tolerated Dose, Safety and Efficacy of Docetaxel / Cisplatin + STI571
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase 1/Phase 2 study of STI571 combined with docetaxel and cisplatin for treatment of patients with recurrent and metastatic Non-Small Cell Lung Cancer (NSCLC). This research study has 2 parts to it. The first part (Phase 1) is called a dose-escalation. Not all subjects enrolled into this phase of the study will receive the same dose. The purpose of the dose-escalation is to determine the highest safe dose of STI571 that can be used in combination with docetaxel and cisplatin. That dose will be used in Phase 2.
Timeline
- Start
- 2004-11
- Primary completion
- 2010-06
- Completion
- 2010-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 60 mg/m2 | Intravenous |
| Subject | Cisplatin | Other / unclassified | 70 mg/m2 | Intravenous |
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 60 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 70 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Imatinib | Small molecule | 300 mg | Oral |
| Subject | Imatinib | Small molecule | 400 mg | Oral |
| Subject | Imatinib | Small molecule | 600 mg | Oral |
| Subject | Imatinib | Small molecule | 800 mg | Oral |