Number: 201012979 Principal Investigator: Uy, Geoffrey
Title: A Phase I/II Study of LBH589 plus Decitabine for Patients Age = 60 Years with High Risk MDS or AML
Phase: I/II Disease Site: Multiple Sites
Participating Site(s):
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You may be asked to participate in this trial if you have been diagnosed with either a Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) and are greater than or equal to 60 years of age. The goal of this clinical research study is to find out the side effects and effectiveness of a drug called LBH589 when given in combination with a drug called decitabine to patients who have been diagnosed with a Myelodysplastic Syndrome or Acute Myeloid Leukemia.
This study is divided into two parts or phases. The first phase is to find the best dose of LBH589 when given with decitabine. The second phase will determine how effective the combination of LBH589 is with decitabine using the dose determined during the first phase of the study. Your doctor will tell you what phase of the study you can participate in and what dose of LBH589 you will be taking. Approximately 66 patients will participate in this study.
LBH589 is made by Novartis Pharmaceuticals Corporation. It is an investigational drug, which means it is not approved by the Food and Drug Administration (FDA) and is only available in clinical trials. LBH589 is a drug that may slow down the growth of cancer cells or kill cancer cells by blocking certain enzymes (proteins produced by cells). LBH589 has shown effects against cancer in laboratory studies and in studies using animals; however, it is not known if this medicine will show the same activity in humans.
Decitabine is approved by the Food and Drug Administration (FDA) for the treatment of Myelodysplastic Syndromes and some forms of Acute Myeloid Leukemia.
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