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

Primary Purpose

Myeloid Leukemia

Status

Terminated

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

AVE9633

About this trial

This is an interventional treatment trial for Myeloid Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office

Outcomes

Primary Outcome Measures

Incidence of Dose Limiting Toxicity(ies) at each tested dose level

Secondary Outcome Measures

Complete Remission (CR) / Remission with incomplete platelet recovery (CRp), Partial Remission (PR) rate, time to CR and duration of CR, peripheral blast clearance

Incidence of Adverse Events

Full Information

NCT ID

NCT00543972

First Posted

October 12, 2007

Last Updated

May 13, 2009

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00543972

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 Type

Interventional

2. Study Status

Record Verification Date

May 2009

Overall Recruitment Status

Terminated

Why Stopped

due to absence of evidence of clinical activity up to toxic doses

Study Start Date

September 2007 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myeloid Leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

AVE9633

Intervention Description

Intravenous Infusion

Primary Outcome Measure Information:

Title

Incidence of Dose Limiting Toxicity(ies) at each tested dose level

Time Frame

Study period

Secondary Outcome Measure Information:

Title

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

Title

Incidence of Adverse Events

Time Frame

Study period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ICD CSD

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Bridgewater

State/Province

New Jersey

ZIP/Postal Code

08807

Country

United States

Facility Name

Sanofi-Aventis Administrative Office

City

Paris

Country

France

Facility Name

Sanofi-Aventis Administrative Office

City

Barcelona

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

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

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