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

• Sponsor: Sanofi (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00543972
• Collaborator: (none)
• Enrollment: 12
• Locations: 3
• Duration (Months): 11
• Patients Per Site: 4
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myeloid Leukemia	Drug: AVE9633	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Sep 1, 2007
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Outcome Measures

Primary Outcome Measures

1. Incidence of Dose Limiting Toxicity(ies) at each tested dose level [Study period]

Secondary Outcome Measures

1. 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]

2. Incidence of Adverse Events [Study period]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey	United States	08807
2	Sanofi-Aventis Administrative Office	Paris		France
3	Sanofi-Aventis Administrative Office	Barcelona		Spain

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: ICD CSD, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00543972
• Other Study ID Numbers: TED10219; EudraCT 2006-005976-41
• First Posted: Oct 15, 2007
• Last Update Posted: May 14, 2009
• Last Verified: May 1, 2009

• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute

Study Results

No Results Posted as of May 14, 2009