drugset / Trial / NCT01169012
PK Study of Oral and IV Clofarabine in High Risk Myelodysplasia+Acute Leukemias
Phase 1
Completed
13 enrolled
UNC Lineberger Comprehensive Cancer Center
Genzyme, a Sanofi Company · collab
NaSingle-groupOpen-labelBasic science
Summary
This is a non-blinded, non-randomized pharmacokinetic study to determine the oral bioavailability of clofarabine, and the effect of cimetidine on clofarabine pharmacokinetics in patients with poor-risk acute leukemias and myelodysplastic syndrome (MDS).
Timeline
- Start
- 2010-09
- Primary completion
- 2012-04
- Completion
- 2013-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cimetidine | Small molecule | 800 mg | — |
| Subject | Clofarabine | Other / unclassified | 10 mg/m2 | Intravenous |
| Subject | Clofarabine | Other / unclassified | 15 mg/m2 | Intravenous |
| Subject | Clofarabine | Other / unclassified | 20 mg/m2 | Intravenous |
| Subject | Clofarabine | Other / unclassified | 30 mg/m2 | Intravenous |
| Subject | Clofarabine | Other / unclassified | 40 mg/m2 | Intravenous |