Phase I-II Study of Idarubicin, Cytarabine, and Sorafenib (BAY43-9006)
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.
Acute Myeloid Leukemia
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I-II Study of Idarubicin, Cytarabine, and Sorafenib (BAY43-9006), an Oral VEGF, RAF and FLT3 Inhibitor, in Patients With High-risk MDS and AML|
- Maximum Tolerated Dose (MTD) [ Time Frame: Twice a week for first two 28 day cycles ] [ Designated as safety issue: Yes ]MTD is dose level where grade 3-4 sorafenib-attributable toxicity in <2 of 6 participants. Dose-Limiting Toxicity graded according to the NCI Common Toxicity Criteria version 3.0.
- Number of Participants With Complete Response [ Time Frame: Baseline to 2 years or disease progression. ] [ Designated as safety issue: No ]Complete response was defined by the presence of < 5% blasts in the bone marrow (BM) with > 1 x 10^9/L platelets in the peripheral blood (PB).
|Study Start Date:||October 2007|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Experimental: Sorafenib + Idarubicin + Ara-C
Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
12 mg/m2 IV over 1 hour daily (days 1-3)
Other Name: Idamycin®, Idamycin PFS®Drug: Sorafenib
Starting dose 400 mg by mouth for 7 days
Other Name: Nexavar®Drug: Ara-C
1.5 g/m2 IV over 24 hours daily (days 1-4)
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|United States, Texas|
|The University of Texas M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Farhad Ravandi-Kashani, MD||M.D. Anderson Cancer Center|