CLINICAL TRIAL SUMMARY

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 Status:Open
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
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.

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Disease Group:Leukemia
Phase of Study:Phase I/Phase II
Treatment Agents:5-Azacytidine
Birinapant
Treatment Location:Both at MDACC & and Other Sites
Estimated Length of Stay in Houston:
Supported By:TetraLogic Pharmaceuticals
Return Visit:
Home Care:


Hide details for Study Contact InformationStudy Contact Information

Physician Name:Gautam Borthakur
Dept:Leukemia
For Clinical Trial Enrollment:713-563-1586
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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