Expired Study
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Bridgewater, New Jersey 08807


Purpose:

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.


Criteria:

Inclusion Criteria: - Patients with CD33-positive acute myeloid leukemia, refractory or relapsed after standard treatment with no curative option available - ECOG performance status 0 to 2 Exclusion Criteria: - Therapy with gemtuzumab ozogamicin (Mylotarg) within 6 months prior to inclusion - Allogenic transplantation within 6 months prior to inclusion - Prior therapy (chemotherapy, targeted agents, radiotherapy) within 3 weeks except for hydroxyurea and for leukophoresis - Previous treatment with AVE9633 - Poor kidney, liver and bone marrow functions - Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study - Pregnant or breast-feeding women - Patient with reproductive potential without effective birth control methods The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Study is Available At:


Original ID:

TED10219


NCT ID:

NCT00543972


Secondary ID:

EudraCT 2006-005976-41


Study Acronym:


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


Overall Status:

Terminated


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Sanofi-Aventis


Oversight Authority:

  • United States: Food and Drug Administration
  • France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
  • Spain: Spanish Agency of Medicines


Reasons Why Stopped:

due to absence of evidence of clinical activ


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

12


Enrollment Type:

Actual


Overall Contact Information

Official Name:ICD CSD
Study Director
Sanofi-Aventis

Study Dates

Start Date:September 2007
Completion Date:August 2008
Completion Type:Actual
Primary Completion Date:August 2008
Primary Completion Type:Actual
Verification Date:May 2009
Last Changed Date:May 13, 2009
First Received Date:October 12, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Incidence of Adverse Events
Time Frame:Study period
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Complete Remission (CR) / Remission with incomplete platelet recovery (CRp), Partial Remission (PR) rate, time to CR and duration of CR, peripheral blast clearance
Time Frame:Study period
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Incidence of Dose Limiting Toxicity(ies) at each tested dose level
Time Frame:Study period
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:AVE9633
Description:Intravenous Infusion

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Sanofi-Aventis

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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