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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00543972

Enrollment

Registered

2007-10-15

Start date

2007-09-30

Completion date

2008-08-31

Last updated

2009-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myeloid Leukemia

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.

Interventions

DRUGAVE9633

Intravenous Infusion

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Incidence of Dose Limiting Toxicity(ies) at each tested dose level	Study period

Secondary

Measure	Time frame
Complete Remission (CR) / Remission with incomplete platelet recovery (CRp), Partial Remission (PR) rate, time to CR and duration of CR, peripheral blast clearance	Study period
Incidence of Adverse Events	Study period

Countries

France, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026