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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
355

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 21, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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