drugset / Trial / NCT01828346
Birinapant With 5-azacitidine in MDS Subjects Who Are Naïve, Have Relapsed or Are Refractory to 5-azacitidine Therapy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |