Spots Global Cancer Trial Database for Dose Escalation Safety and Pharmacokinetic Study of AVE9633 as Single Agent in Relapsed/Refractory CD33-Positive Acute Myeloid Leukemia
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Trial Identification
Brief Title: Dose Escalation Safety and Pharmacokinetic Study of AVE9633 as Single Agent in Relapsed/Refractory CD33-Positive Acute Myeloid Leukemia
Official Title: 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)
Study ID: NCT00543972
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sanofi-Aventis Administrative Office, Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office, Paris, , France
Sanofi-Aventis Administrative Office, Barcelona, , Spain
Contact Details
Name: ICD CSD
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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