A Study of AVE8062 in Advanced-stage Soft Tissue Sarcoma After Failure of Anthracycline and Ifosfamide Chemotherapies

November 18, 2015 updated by: Sanofi

A Multinational, Randomized, Double-blind Placebo Controlled Study of AVE8062 (25 mg/m2) Administered Every 3 Weeks in Patients With Advanced-stage Soft Tissue Sarcoma, Treated With Cisplatin (75 mg) After Failure of Anthracycline and Ifosfamide Chemotherapies.

The primary objective of the study is to compare the progression-free survival (PFS) in the 2 treatment arms

The secondary objectives of the study are :

  • To compare the overall survival in the 2 treatment arms
  • To compare the objective response rate in the 2 treatment arms
  • To assess the safety profile of AVE8062 (in combination with the background cisplatin therapy)
  • To assess the pharmacokinetics of AVE8062 and its main metabolite, RPR258063, using a population approach, in all patients enrolled in selected centers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

355

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • Investigational Site Number 056001
      • Haine-Saint-Paul, Belgium, 7100
        • Investigational Site Number 056004
      • Liège, Belgium, 4000
        • Investigational Site Number 056005
  • Brazil
      • Belo Horizonte, Brazil, 30130-100
        • Investigational Site Number 076007
      • Goiania, Brazil, 74070-040
        • Investigational Site Number 076008
      • Ijui, Brazil, 98700 000
        • Investigational Site Number 076003
      • Jau, Brazil, 17210-120
        • Investigational Site Number 076004
      • Novo Hamburgo, Brazil, 93511 970
        • Investigational Site Number 076006
      • Porto Alegre, Brazil, 90020-090
        • Investigational Site Number 076002
      • Porto Alegre, Brazil, 90035 003
        • Investigational Site Number 076005
      • Rio De Janeiro, Brazil, 20230-130
        • Investigational Site Number 076009
  • France
      • Bordeaux, France, 33076
        • Investigational Site Number 250008
      • Dijon, France, 21079
        • Investigational Site Number 250002
      • Lille, France, 59010
        • Investigational Site Number 250004
      • Lyon Cedex 03, France, 69437
        • Investigational Site Number 250001
      • Marseille, France, 13385
        • Investigational Site Number 250010
      • Montpellier Cedex, France, 34094
        • Investigational Site Number 250006
      • Nice Cedex 02, France, 06189
        • Investigational Site Number 250007
      • Rennes, France, 35000
        • Investigational Site Number 250005
      • Saint Cloud, France, 92210
        • Investigational Site Number 250003
      • Saint Priest En Jarez, France, 42270
        • Investigational Site Number 250012
      • Saint-Herblain, France, 44800
        • Investigational Site Number 250009
  • Hungary
      • Budapest, Hungary, 1134
        • Investigational Site Number 348001
      • Debrecen, Hungary, 4032
        • Investigational Site Number 348002
  • India
      • Bangalore, India, 560054
        • Investigational Site Number 356005
      • Hyderabad, India, 500033
        • Investigational Site Number 356003
      • New Delhi, India, 110076
        • Investigational Site Number 356004
  • Italy
      • Aviano, Italy, 33081
        • Investigational Site Number 380001
      • Milano, Italy, 20133
        • Investigational Site Number 380003
      • Milano, Italy, 20141
        • Investigational Site Number 380004
      • Rozzano, Italy, 20089
        • Investigational Site Number 380002
  • Serbia
      • Belgrade, Serbia, 11000
        • Investigational Site Number 891001
      • Sremska Kamenica, Serbia, 21204
        • Investigational Site Number 891002
  • Spain
      • Barcelona, Spain, 08025
        • Investigational Site Number 724004
      • Madrid, Spain, 28040
        • Investigational Site Number 724001
      • Pamplona, Spain, 31008
        • Investigational Site Number 724003
  • United Kingdom
      • Bebington, United Kingdom, CH63 4JY
        • Investigational Site Number 826001
      • Bristol, United Kingdom, BS2 8ED
        • Investigational Site Number 826003
      • Newcastle Upon Tyne, United Kingdom, NE4 6BE
        • Investigational Site Number 826002
  • United States
    • California
      • Santa Monica, California, United States, 90403
        • Investigational Site Number 840004
    • Florida
      • Orlando, Florida, United States, 32806
        • Investigational Site Number 840003
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Investigational Site Number 840005
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Investigational Site Number 840002
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Investigational Site Number 840007
    • Texas
      • San Antonio, Texas, United States, 78229
        • Investigational Site Number 840001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Histologically proven soft tissue sarcoma
  • Unresectable locoregional recurrent or metastatic soft tissue sarcoma
  • Failure of a previous anthracycline-based regimen administered recommended dose and of prior ifosfamide therapy

Exclusion criteria:

  • Less than 3 weeks elapsed from prior treatment with radiotherapy, surgery, or chemotherapy to the time of randomization
  • Brain metastases and carcinomatous leptomeningitis
  • Uncontrolled hypertension
  • Known platinum hypersensitivity

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: OMBRABULIN (AVE8062)
I.V. infusion followed by administration of cisplatin
Placebo Comparator: 2
Drug: Placebo
I.V. infusion followed by administration of cisplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: until event or study cut-off date (Tumor assessment every 6 weeks)
until event or study cut-off date (Tumor assessment every 6 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: until event or study cut-off date
until event or study cut-off date
Response rate
Time Frame: tumor assessment every 6 weeks
tumor assessment every 6 weeks
Safety profile
Time Frame: assessment every 3 weeks
assessment every 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

May 7, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (Estimate)

June 18, 2008

Study Record Updates

Last Update Posted (Estimate)

December 21, 2015

Last Update Submitted That Met QC Criteria

November 18, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC10145
  • EudraCT 2007-003592-39

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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