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A Phase I/II Study of ON 01910.Na in Patients with Intermediate-1, Intermediate-2 or High-Risk Myelodysplastic Syndrome
[Protocol 09-006]
- Full Title :
- A PHASE I/2, SINGLE-ARM STUDY TO ASSESS THE EFFICACY AND SAFETY OF A 5-DAY CONTINUOUS INTRAVENOUS DOSING OF ON01910.NA, ADMINISTERED EVERY 2 WEEKS IN PATIENTS WITH INTERMEDIATE-1, INTERMEDIATE-2, OR HIGH RISK MYELODYSPLASTIC SYNDROME (MDS)
- Purpose :
In people with myelodysplastic syndromes (MDS), the bone marrow does not work normally. As a result, they have abnormally low levels of functioning blood cells (such as red blood cells, white blood cells, and platelets).
The purpose of this study it to evaluate the safety and effectiveness of an investigational drug called ON 01910.Na in patients with MDS that requires treatment even though they previously received decitabine or 5-azacytidine. Doctors don't know exactly how ON 01910.Na works, but it appears to have a killing effect on cancer cells and MDS cells in laboratory studies.
In a study of ON 01910.Na in people with MDS, some of the patients are experiencing improvements in their bone marrow function.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have MDS that has persisted despite prior treatment with four to six cycles of decitabine or 5-azacytidine.
- Patients must have not responded to, relapsed after, or opted not to have bone marrow transplantation.
- At least 4 weeks must have passed since taking prior MDS treatments (2 weeks for G-CSF and erythropoietin).
- Patients must not be confined to a bed or chair for more than half of their normal waking hours.
For more information about this study and to inquire about eligibility, please contact Dr. Virginia Klimek at 212-639-6519.
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