Phase I-II Study of Idarubicin, Cytarabine, and Sorafenib (BAY43-9006)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00542971|
Recruitment Status : Completed
First Posted : October 12, 2007
Results First Posted : July 13, 2012
Last Update Posted : July 13, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|AML Acute Myeloid Leukemia Myelodysplastic Disorders||Drug: Idarubicin Drug: Sorafenib Drug: Ara-C||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2007|
|Primary Completion Date :||May 2011|
|Study Completion Date :||May 2011|
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)
- Maximum Tolerated Dose (MTD) [ Time Frame: Twice a week for first two 28 day cycles ]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. ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542971
|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|