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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)


Phase 1
18 Years
N/A
Not Enrolling
Both
Myeloid Leukemia

Thank you

Trial Information

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)


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Study period

Safety Issue:

Yes

Principal Investigator

ICD CSD

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

TED10219

NCT ID:

NCT00543972

Start Date:

September 2007

Completion Date:

August 2008

Related Keywords:

  • Myeloid Leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Sanofi-Aventis Administrative Office Bridgewater, New Jersey  08807