A Phase III, Multi-Center, Randomized, Controlled Study to Assess the Efficacy and Safety of ON 01910.Na administered as a 72-hour continuous intravenous infusion every other week in MDS patients with excess blasts relapsing after, or refractory to, or intolerant to Azacitidine or Decitabine
ID Number 11-1244Principal Investigator(s)
Lewis R. Silverman
Department(s) or Division(s)
Hematology and Medical Oncology
The purpose of this study is to determine how well a drug called ON 01910.Na (also known as Rigosertib) works on people with Myelodysplastic Syndrome (MDS) and to study the safety of ON 01910.Na when it is given to people with MDS. Although researchers do not know what causes MDS, they do know its symptoms and effects. In MDS, the bone marrow releases very few blood cells into the blood for use in the body. Therefore, patients with MDS often need transfusions of red blood cells for anemia, platelet transfusions for low platelet counts or bleeding, and antibiotics for serious infections that occur because of low white blood cell counts. Your MDS may have caused an accumulation of abnormal cells called blasts, and this puts you at a high risk of developing leukemia.
ON 01910.Na (the study drug) is an experimental drug. This means that it is not approved by the U.S. Food and Drug Administration (FDA) for use except for research purposes. ON 01910.Na is being studied as a possible anticancer drug. Although how ON 01910.Na works is not fully known, it is thought to kill cancer cells by stopping the tumor cells from dividing and growing and by causing cells to die.
You may qualify to take part in this research study because you have Myelodysplastic Syndrome with Excess Blasts Relapsing After, or Refractory to, or Intolerant to Azacitidine or Decitabine.
Recruiting Patients: Yes