drugset / Trial / NCT02147873

Study of Azacitidine With or Without Birinapant in Subjects With MDS or CMMoL

NCT02147873

Phase 2 Terminated 118 enrolled TetraLogic Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized double blind placebo controlled study of azacitidine with or without birinapant in subjects with higher risk Myelodysplastic syndrome, secondary MDS or myelomonocytic leukemia (CMMoL) who are naïve, to azacitidine therapy. Pre-clinical and mechanistic studies support that azacitidine may modulate pathways that enable birinapant-mediated anti-tumor activity.

Timeline

Start
2014-06
Primary completion
2016-01
Completion
2016-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Birinapant Small molecule 13 mg/m2 Intravenous
Comparator Azacitidine Other / unclassified 75 mg/m2