drugset / Trial / NCT00542971
Phase I-II Study of Idarubicin, Cytarabine, and Sorafenib (BAY43-9006)
NaSingle-groupOpen-labelTreatment
Summary
A primary goal of this clinical research study is to find the highest safe dose of sorafenib that can be given in combination with idarubicin and Ara-C for the treatment of acute myelogenous leukemia (AML) and high-risk, myelodysplastic syndrome (MDS). Once the highest safe dose is found, researchers will then try to learn if this combination treatment can help control AML and high-risk MDS in newly diagnosed patients. The safety of this treatment combination will also be studied.
Timeline
- Start
- 2007-10
- Primary completion
- 2011-05
- Completion
- 2011-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | 1.5 g | Intravenous |
| Subject | Idarubicin | Small molecule | 12 mg/m2 | Intravenous |
| Subject | Sorafenib | Small molecule | 400 mg | Oral |