A Phase 2, Randomized, Double-Blind, Placebo Controlled Study of Azacitidine with or without Birinapant with a Single Arm Open-Label Run-In Phase in Subjects with Higher Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia.
A study for patients with myelodysplastic syndrome or chronic myelomonocytic leukemia using study drug birinapant
Sponsor: TetraLogic Pharmaceuticals
Enrolling: Male and Female Patients
IRB Number: AAAO2454
U.S. Govt. ID: NCT02147873
Contact: Joseph Juric: 646-317-5191 / jgj2110@columbia.edu
Additional Study Information: The purpose of this part of the study is to obtain further information about the safety and effectiveness(how well it works) of azacitidine plus birinapant (the investigational drug), in people with higher-risk myelodysplastic syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMMoL). One of the standard drugs for these diseases is azacitidine which all participants on this trial will receive. In addition you will receive birinapant (the investigational drug). Birinapant is being studied as a potential new treatment for cancer. "Investigational" means thedrug is being tested and has not been approved for sale in the United States by the U.S. Food andDrug Administration (FDA). Studies with birinapant have been performed, but more informationis needed about how it can help to possibly treat cancer. Birinapant removes certain chemicals(proteins) in a cancer cell which leads to the death of cancer cells.
This study is closed
Investigator
Joseph Jurcic, MD
Do You Qualify?
Do you have a confirmed diagnosis of MDS or CMMoL? Yes No
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For more information, please contact:
Joseph Juric
jgj2110@columbia.edu
646-317-5191