Clinical trial NCT00699517: A Study of AVE8062 in Advanced-stage Soft Tissue Sarcoma After Failure of Anthracycline and Ifosfamide Chemotherapies
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sarcoma
Keywords: tubulin modulator
endothelium
combretastatin
cisplatin
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-06-18
Enrollment: 355
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression free survival
timeFrame: until event or study cut-off date (Tumor assessment every 6 weeks)
Secondary outcomes:
measure: Overall survival
timeFrame: until event or study cut-off date
measure: Response rate
timeFrame: tumor assessment every 6 weeks
measure: Safety profile
timeFrame: assessment every 3 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Investigational Site Number 840004
state: California
city: Orlando
country: United States
facility: Investigational Site Number 840003
state: Florida
city: Maywood
country: United States
facility: Investigational Site Number 840005
state: Illinois
city: Newark
country: United States
facility: Investigational Site Number 840002
state: New Jersey
city: Philadelphia
country: United States
facility: Investigational Site Number 840007
state: Pennsylvania
city: San Antonio
country: United States
facility: Investigational Site Number 840001
state: Texas
city: Bruxelles
country: Belgium
facility: Investigational Site Number 056001
city: Haine-Saint-Paul
country: Belgium
facility: Investigational Site Number 056004
city: Liège
country: Belgium
facility: Investigational Site Number 056005
city: Belo Horizonte
country: Brazil
facility: Investigational Site Number 076007
city: Goiania
country: Brazil
facility: Investigational Site Number 076008
city: Ijui
country: Brazil
facility: Investigational Site Number 076003
city: Jau
country: Brazil
facility: Investigational Site Number 076004
city: Novo Hamburgo
country: Brazil
facility: Investigational Site Number 076006
city: Porto Alegre
country: Brazil
facility: Investigational Site Number 076002
city: Porto Alegre
country: Brazil
facility: Investigational Site Number 076005
city: Rio De Janeiro
country: Brazil
facility: Investigational Site Number 076009
city: Bordeaux
country: France
facility: Investigational Site Number 250008
city: Dijon
country: France
facility: Investigational Site Number 250002
city: Lille
country: France
facility: Investigational Site Number 250004
city: Lyon Cedex 03
country: France
facility: Investigational Site Number 250001
city: Marseille
country: France
facility: Investigational Site Number 250010
city: Montpellier Cedex
country: France
facility: Investigational Site Number 250006
city: Nice Cedex 02
country: France
facility: Investigational Site Number 250007
city: Rennes
country: France
facility: Investigational Site Number 250005
city: Saint Cloud
country: France
facility: Investigational Site Number 250003
city: Saint Priest En Jarez
country: France
facility: Investigational Site Number 250012
city: Saint-Herblain
country: France
facility: Investigational Site Number 250009
city: Budapest
country: Hungary
facility: Investigational Site Number 348001
city: Debrecen
country: Hungary
facility: Investigational Site Number 348002
city: Bangalore
country: India
facility: Investigational Site Number 356005
city: Hyderabad
country: India
facility: Investigational Site Number 356003
city: New Delhi
country: India
facility: Investigational Site Number 356004
city: Aviano
country: Italy
facility: Investigational Site Number 380001
city: Milano
country: Italy
facility: Investigational Site Number 380003
city: Milano
country: Italy
facility: Investigational Site Number 380004
city: Rozzano
country: Italy
facility: Investigational Site Number 380002
city: Belgrade
country: Serbia
facility: Investigational Site Number 891001
city: Sremska Kamenica
country: Serbia
facility: Investigational Site Number 891002
city: Barcelona
country: Spain
facility: Investigational Site Number 724004
city: Madrid
country: Spain
facility: Investigational Site Number 724001
city: Pamplona
country: Spain
facility: Investigational Site Number 724003
city: Bebington
country: United Kingdom
facility: Investigational Site Number 826001
city: Bristol
country: United Kingdom
facility: Investigational Site Number 826003
city: Newcastle Upon Tyne
country: United Kingdom
facility: Investigational Site Number 826002
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: 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.