drugset / Trial / NCT01828346

Birinapant With 5-azacitidine in MDS Subjects Who Are Naïve, Have Relapsed or Are Refractory to 5-azacitidine Therapy

NCT01828346

Phase 1/2 Completed 21 enrolled TetraLogic Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

This is a dose escalation followed by dose expansion study of TL32711 in combination with 5-Azacitidine in subjects with Myelodysplastic syndrome who are naïve, have relapsed or have failed prior 5-azacitidine therapy. Pre-clinical and mechanistic studies support that 5-Azacitidine may modulate pathways that enable birinapant-mediated anti-tumor activity.

Timeline

Start
2013-06
Primary completion
2015-06
Completion
2015-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Birinapant Small molecule 11 mg/m2
Subject Birinapant Small molecule 13 mg/m2
Subject Birinapant Small molecule 17 mg/m2
Background Azacitidine Other / unclassified 75 mg/m2