drugset / Trial / NCT01993641
Phase 2 Study Adding Pracinostat to a Hypomethylating Agent (HMA) in Patients With MDS Who Failed to Respond to Single Agent HMA
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this open label study is to determine whether combining pracinostat (study drug) with Vidaza (azacitidine) or Dacogen (decitabine) will improve clinical responses in Myelodysplastic Syndrome (MDS) patients who have failed an initial single agent hypomethylating agent (HMA), and to provide additional safety and efficacy data.
Timeline
- Start
- 2013-12
- Primary completion
- 2015-05
- Completion
- 2016-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pracinostat | Other / unclassified | — | — |
| Background | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Background | Decitabine | Small molecule | 10 mg/m2 | Intravenous |
| Background | Decitabine | Small molecule | 15 mg/m2 | Intravenous |
| Background | Decitabine | Small molecule | 20 mg/m2 | Intravenous |