drugset / Trial / NCT00543972
Dose Escalation Safety and Pharmacokinetic Study of AVE9633 as Single Agent in Relapsed/Refractory CD33-Positive Acute Myeloid Leukemia
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The primary objective is to determine the maximum tolerated dose of AVE9633 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-leukemia activity, the global safety and the PK profile.
Timeline
- Start
- 2007-09
- Primary completion
- 2008-08
- Completion
- 2008-08
Outcome
Outcome not reported
Stopped: “due to absence of evidence of clinical activity up to toxic doses”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AVE9633 | Unknown | — | Intravenous |