drugset / Trial / NCT00615927
Phase II Imatinib + Hydroxyurea in Treatment of Patients With Recurrent/Progressive Grade II Low-Grade Glioma (LGG)
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Primary objective: * To evaluate activity of imatinib mesylate and hydroxyurea among patients with progressive/recurrent grade II low-grade glioma (LGG) as measured by 12-month progression free survival Secondary objectives: * To evaluate progression-free survival (PFS), overall survival and objective response rate among patients with progressive/recurrent grade II LGG treated with imatinib mesylate plus hydroxyurea * To assess safety and tolerability of imatinib mesylate + hydroxyurea in this population
Timeline
- Start
- 2006-02
- Primary completion
- 2009-04
- Completion
- 2012-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydroxyurea | Other / unclassified | 500 mg | Oral |
| Subject | Imatinib | Small molecule | 400 mg | Oral |
| Subject | Imatinib | Small molecule | 500 mg | Oral |
| Subject | Imatinib | Small molecule | 600 mg | Oral |
| Subject | Imatinib | Small molecule | 800 mg | Oral |