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Treatment Study for Patients with Myelodysplastic Syndrome or Acute Myeloid Leukemia
Myelodysplastic syndromes (MDS) are a group of cancers in which immature blood cells in the bone marrow do not mature or become healthy blood cells.
This research study will use azacitidine combined with rigosertib, a new anticancer drug, which is investigational (not approved by the U.S. Food and Drug Administration or any other regulatory authority). Although the mechanism of action of rigosertib is not fully known, it is thought to kill cancer cells by two different actions: it stops the tumor cells from dividing and growing, and blocks the proteins involved in cell division causing cells to die. Azacitidine is already approved for the treatment of MDS.
In order to participate you must meet the following criteria:
- Have been diagnosed with MDS, acute myeloid leukemia (AML), or chronic myelomonocytic leukemia (CMML).
- Aree off all other treatments for MDS, CMML, or AML for at least 4 weeks prior to screening.
- Are classified as Intermediate-1, Intermediate-2 or High-risk if diagnosed with MDS.
- Have received no more than 1 prior treatment if diagnosed with AML must.
- Are able to swallow pills.
You will be excluded from the study if any of the following criteria apply to you:
- Have had prior treatment with rigosertib.
- Have anemia due to factors other than MDS, CMML, or AML.
- Have uncontrolled high blood pressure.
- Have used corticosteroids more than 2 weeks, more than 10 milligrams/24 hours within 4 weeks prior to screening.
This is a partial list of inclusion and exclusion criteria.