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

Phase 3

Completed

• Conditions: Sarcoma
• Interventions: Drug: Placebo; Drug: OMBRABULIN (AVE8062)

• Registration Number: NCT00699517
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-07
• Study Start: 2008-06
• Study First Submitted QC: 2008-06-17
• Study First Posted: 2008-06-18
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2015-11
• Disposition First Submitted: 2015-11-18
• Disposition First Submitted QC: 2015-11-18
• Last Update Submitted: 2015-11-18
• Disposition First Posted: 2015-12-21
• Last Update Posted: 2015-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 355

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	OMBRABULIN (AVE8062)	-

Primary Outcome Measures

Name	Time	Method
Progression free survival	until event or study cut-off date (Tumor assessment every 6 weeks)

Secondary Outcome Measures

Name	Time	Method
Overall survival	until event or study cut-off date
Response rate	tumor assessment every 6 weeks
Safety profile	assessment every 3 weeks

Trial Locations

Locations (45)

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; 🇧🇪 Bruxelles, Belgium

Investigational Site Number 056004; 🇧🇪 Haine-Saint-Paul, Belgium

Investigational Site Number 056005; 🇧🇪 Liège, Belgium

Investigational Site Number 076007; 🇧🇷 Belo Horizonte, Brazil

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