drugset / Trial / NCT00542971

Phase I-II Study of Idarubicin, Cytarabine, and Sorafenib (BAY43-9006)

NCT00542971

Phase 1/2 Completed 78 enrolled M.D. Anderson Cancer Center Bayer · collab
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

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule 1.5 g Intravenous
Subject Idarubicin Small molecule 12 mg/m2 Intravenous
Subject Sorafenib Small molecule 400 mg Oral