Trials / Terminated
TerminatedNCT00543972
Dose Escalation Safety and Pharmacokinetic Study of AVE9633 as Single Agent in Relapsed/Refractory CD33-Positive Acute Myeloid Leukemia
An Open Label, Dose-Escalation Safety and Pharmacokinetic Study of AVE9633 Administered as a Single Agent by Intravenous Infusion on Day 1, Day 4 and Day 7 of a 4-Week Cycle in Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia (AML)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AVE9633 | Intravenous Infusion |
Timeline
- Start date
- 2007-09-01
- Primary completion
- 2008-08-01
- Completion
- 2008-08-01
- First posted
- 2007-10-15
- Last updated
- 2009-05-14
Locations
3 sites across 3 countries: United States, France, Spain
Source: ClinicalTrials.gov record NCT00543972. Inclusion in this directory is not an endorsement.