|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 dose of birinapant that |
is safe and tolerated when 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 the disease.
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.