drugset / Trial / NCT01503502
A Phase II Study of Flumatinib Versus Imatinib to Treat Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
RandomizedParallel-groupOpen-labelTreatment
Summary
It is an open-label, randomized, multi-center study. The efficacy and safety of two flumatinib doses, 400 mg once daily and 600 mg once daily, will be compared with imatinib 400 mg once daily in newly diagnosed (within 6 months) patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).
Timeline
- Start
- 2011-08
- Primary completion
- 2012-06
- Completion
- 2014-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Flumatinib | Small molecule | 400 mg | Oral |
| Subject | Flumatinib | Small molecule | 600 mg | Oral |
| Comparator | Imatinib | Small molecule | 400 mg | Oral |