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

Sarcoma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00699517
• Other study ID #: EFC10145
• Secondary ID: EudraCT 2007-003
• Status: Completed
• Phase: Phase 3
• First received: May 7, 2008
• Last updated: November 18, 2015
• Start date: June 2008
• Est. completion date: April 2013

Study information

• Verified date: November 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma

Intervention

Drug:
• OMBRABULIN (AVE8062)
I.V. infusion followed by administration of cisplatin
• Placebo
I.V. infusion followed by administration of cisplatin

Locations

Country	Name	City	State
Belgium	Investigational Site Number 056001	Bruxelles
Belgium	Investigational Site Number 056004	Haine-Saint-Paul
Belgium	Investigational Site Number 056005	Liège
Brazil	Investigational Site Number 076007	Belo Horizonte
Brazil	Investigational Site Number 076008	Goiania
Brazil	Investigational Site Number 076003	Ijui
Brazil	Investigational Site Number 076004	Jau
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
France	Investigational Site Number 250008	Bordeaux
France	Investigational Site Number 250002	Dijon
France	Investigational Site Number 250004	Lille
France	Investigational Site Number 250001	Lyon Cedex 03
France	Investigational Site Number 250010	Marseille
France	Investigational Site Number 250006	Montpellier Cedex
France	Investigational Site Number 250007	Nice Cedex 02
France	Investigational Site Number 250005	Rennes
France	Investigational Site Number 250003	Saint Cloud
France	Investigational Site Number 250012	Saint Priest En Jarez
France	Investigational Site Number 250009	Saint-Herblain
Hungary	Investigational Site Number 348001	Budapest
Hungary	Investigational Site Number 348002	Debrecen
India	Investigational Site Number 356005	Bangalore
India	Investigational Site Number 356003	Hyderabad
India	Investigational Site Number 356004	New Delhi
Italy	Investigational Site Number 380001	Aviano
Italy	Investigational Site Number 380003	Milano
Italy	Investigational Site Number 380004	Milano
Italy	Investigational Site Number 380002	Rozzano
Serbia	Investigational Site Number 891001	Belgrade
Serbia	Investigational Site Number 891002	Sremska Kamenica
Spain	Investigational Site Number 724004	Barcelona
Spain	Investigational Site Number 724001	Madrid
Spain	Investigational Site Number 724003	Pamplona
United Kingdom	Investigational Site Number 826001	Bebington
United Kingdom	Investigational Site Number 826003	Bristol
United Kingdom	Investigational Site Number 826002	Newcastle Upon Tyne
United States	Investigational Site Number 840005	Maywood	Illinois
United States	Investigational Site Number 840002	Newark	New Jersey
United States	Investigational Site Number 840003	Orlando	Florida
United States	Investigational Site Number 840007	Philadelphia	Pennsylvania
United States	Investigational Site Number 840001	San Antonio	Texas
United States	Investigational Site Number 840004	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  France,  Hungary,  India,  Italy,  Serbia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		until event or study cut-off date (Tumor assessment every 6 weeks)	No
Secondary	Overall survival		until event or study cut-off date	No
Secondary	Response rate		tumor assessment every 6 weeks	No
Secondary	Safety profile		assessment every 3 weeks	Yes