|MDACC Study No:||2013-0141 (clinicaltrials.gov NCT No: NCT01828346)|
|Title:||A Phase 1b/2a, Open-label, Non-randomized Study of Birinapant in Combination with 5-azacitidine in Subjects with Myelodysplastic Syndrome who are Naive, Refractory or have Relapsed to 5-azacitidine Therapy|
|Principal Investigator:||Gautam Borthakur|
|Treatment Agent:||5-Azacytidine; Birinapant|
|Study Description:||The goal of this clinical research study is to find the highest tolerable dose |
of birinapant that can be given with azacitidine to patients who have not taken
azacitidine before, or who have MDS that did not respond to azacitidine or has
relapsed after taking azacitidine. Pharmacodynamic (PD) testing will also be
done. PD testing measures how the level of study drug in your body may affect
Birinapant is designed to remove certain proteins in cancer cells, which may
cause the cancer cells to die.
Azacitidine is designed to block certain proteins in cancer cells whose job is
to stop the function of the tumor-fighting proteins. By blocking the "bad"
proteins, the tumor-fighting proteins may be able to work better.