drugset / Trial / NCT00543972

Dose Escalation Safety and Pharmacokinetic Study of AVE9633 as Single Agent in Relapsed/Refractory CD33-Positive Acute Myeloid Leukemia

NCT00543972 ↗

Phase 1 Terminated 12 enrolled Sanofi
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

EvaluationDrugModalityDoseRoute
Subject AVE9633 Unknown — Intravenous

Indications