A Study of AVE8062 in Advanced-stage Soft Tissue Sarcoma After Failure of Anthracycline and Ifosfamide Chemotherapies
NCT ID: NCT00699517
Last Updated: 2015-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
355 participants
INTERVENTIONAL
2008-06-30
2013-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
OMBRABULIN (AVE8062)
I.V. infusion followed by administration of cisplatin
2
Placebo
I.V. infusion followed by administration of cisplatin
Interventions
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OMBRABULIN (AVE8062)
I.V. infusion followed by administration of cisplatin
Placebo
I.V. infusion followed by administration of cisplatin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 840004
Santa Monica, California, United States
Investigational Site Number 840003
Orlando, Florida, United States
Investigational Site Number 840005
Maywood, Illinois, United States
Investigational Site Number 840002
Newark, New Jersey, United States
Investigational Site Number 840007
Philadelphia, Pennsylvania, United States
Investigational Site Number 840001
San Antonio, Texas, United States
Investigational Site Number 056001
Brussels, , Belgium
Investigational Site Number 056004
Haine-Saint-Paul, , Belgium
Investigational Site Number 056005
Liège, , Belgium
Investigational Site Number 076007
Belo Horizonte, , Brazil
Investigational Site Number 076008
Goiânia, , Brazil
Investigational Site Number 076003
Ijuí, , Brazil
Investigational Site Number 076004
Jaú, , Brazil
Investigational Site Number 076006
Novo Hamburgo, , Brazil
Investigational Site Number 076002
Porto Alegre, , Brazil
Investigational Site Number 076005
Porto Alegre, , Brazil
Investigational Site Number 076009
Rio de Janeiro, , Brazil
Investigational Site Number 250008
Bordeaux, , France
Investigational Site Number 250002
Dijon, , France
Investigational Site Number 250004
Lille, , France
Investigational Site Number 250001
Lyon, , France
Investigational Site Number 250010
Marseille, , France
Investigational Site Number 250006
Montpellier, , France
Investigational Site Number 250007
Nice, , France
Investigational Site Number 250005
Rennes, , France
Investigational Site Number 250003
Saint-Cloud, , France
Investigational Site Number 250009
Saint-Herblain, , France
Investigational Site Number 250012
Saint-Priest-en-Jarez, , France
Investigational Site Number 348001
Budapest, , Hungary
Investigational Site Number 348002
Debrecen, , Hungary
Investigational Site Number 356005
Bangalore, , India
Investigational Site Number 356003
Hyderabad, , India
Investigational Site Number 356004
New Delhi, , India
Investigational Site Number 380001
Aviano, , Italy
Investigational Site Number 380003
Milan, , Italy
Investigational Site Number 380004
Milan, , Italy
Investigational Site Number 380002
Rozzano, , Italy
Investigational Site Number 891001
Belgrade, , Serbia
Investigational Site Number 891002
Kamenitz, , Serbia
Investigational Site Number 724004
Barcelona, , Spain
Investigational Site Number 724001
Madrid, , Spain
Investigational Site Number 724003
Pamplona, , Spain
Investigational Site Number 826001
Bebington, , United Kingdom
Investigational Site Number 826003
Bristol, , United Kingdom
Investigational Site Number 826002
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Blay JY, Papai Z, Tolcher AW, Italiano A, Cupissol D, Lopez-Pousa A, Chawla SP, Bompas E, Babovic N, Penel N, Isambert N, Staddon AP, Saada-Bouzid E, Santoro A, Franke FA, Cohen P, Le-Guennec S, Demetri GD. Ombrabulin plus cisplatin versus placebo plus cisplatin in patients with advanced soft-tissue sarcomas after failure of anthracycline and ifosfamide chemotherapy: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2015 May;16(5):531-40. doi: 10.1016/S1470-2045(15)70102-6. Epub 2015 Apr 8.
Other Identifiers
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EudraCT 2007-003592-39
Identifier Type: -
Identifier Source: secondary_id
EFC10145
Identifier Type: -
Identifier Source: org_study_id