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

Sanofi

Status and phase: Terminated; Phase 1

Conditions: Myeloid Leukemia

Treatments: Drug: AVE9633

Study type: Interventional

Funder types: Industry

Identifiers

NCT00543972

TED10219

EudraCT 2006-005976-41

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)