drugset / Trial / NCT01063257
Clofarabine in High Risk Myelodysplastic Syndrome (MDS)
Phase 1/2
Completed
76 enrolled
Groupe Francophone des Myelodysplasies
Genzyme, a Sanofi Company · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study aims to determine the maximal tolerated dose (MTD) and dose limiting toxicities (DLTs) of low dose IV clofarabine for MDS patients after treatment failure of azacitidine.
Timeline
- Start
- 2010-04
- Primary completion
- 2014-03
- Completion
- 2014-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clofarabine | Other / unclassified | 2.5 mg/m2 | Intravenous |
| Subject | Clofarabine | Other / unclassified | 5 mg/m2 | Intravenous |
| Subject | Clofarabine | Other / unclassified | 6.5 mg/m2 | Intravenous |
| Subject | Clofarabine | Other / unclassified | 7.5 mg/m2 | Intravenous |
| Subject | Clofarabine | Other / unclassified | 8.5 mg/m2 | Intravenous |
| Subject | Clofarabine | Other / unclassified | 10 mg/m2 | Intravenous |
| Subject | Clofarabine | Other / unclassified | 11.5 mg/m2 | Intravenous |
| Subject | Clofarabine | Other / unclassified | 12.5 mg/m2 | Intravenous |