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

NCT00699517 | Completed Phase 3 DMC

• 2 other identifiers: EFC10145EudraCT 2007-003592-39
• Study Type: interventional
• Target: 355
• Locations: 10 countries
• Sites: 45

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.

Conditions

Sarcoma

Keywords

tubulin modulator; endothelium; combretastatin; cisplatin

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  until event or study cut-off date (Tumor assessment every 6 weeks)

Secondary Outcomes (3)

• Overall survival

  until event or study cut-off date

• Response rate

  tumor assessment every 6 weeks

• Safety profile

  assessment every 3 weeks

Study Arms (2)

1

EXPERIMENTAL

Drug: OMBRABULIN (AVE8062)

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

OMBRABULIN (AVE8062) DRUG

I.V. infusion followed by administration of cisplatin

1

Placebo DRUG

I.V. infusion followed by administration of cisplatin

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (45)

Investigational Site Number 840004

Santa Monica, California, 90403, United States

Location

Investigational Site Number 840003

Orlando, Florida, 32806, United States

Location

Investigational Site Number 840005

Maywood, Illinois, 60153, United States

Location

Investigational Site Number 840002

Newark, New Jersey, 07103, United States

Location

Investigational Site Number 840007

Philadelphia, Pennsylvania, United States

Location

Investigational Site Number 840001

San Antonio, Texas, 78229, United States

Location

Investigational Site Number 056001

Brussels, 1200, Belgium

Location

Investigational Site Number 056004

Haine-Saint-Paul, 7100, Belgium

Location

Investigational Site Number 056005

Liège, 4000, Belgium

Location

Investigational Site Number 076007

Belo Horizonte, 30130-100, Brazil

Location

Investigational Site Number 076008

Goiânia, 74070-040, Brazil

Location

Investigational Site Number 076003

Ijuí, 98700 000, Brazil

Location

Investigational Site Number 076004

Jaú, 17210-120, Brazil

Location

Investigational Site Number 076006

Novo Hamburgo, 93511 970, Brazil

Location

Investigational Site Number 076002

Porto Alegre, 90020-090, Brazil

Location

Investigational Site Number 076005

Porto Alegre, 90035 003, Brazil

Location

Investigational Site Number 076009

Rio de Janeiro, 20230-130, Brazil

Location

Investigational Site Number 250008

Bordeaux, 33076, France

Location

Investigational Site Number 250002

Dijon, 21079, France

Location

Investigational Site Number 250004

Lille, 59010, France

Location

Investigational Site Number 250001

Lyon, 69437, France

Location

Investigational Site Number 250010

Marseille, 13385, France

Location

Investigational Site Number 250006

Montpellier, 34094, France

Location

Investigational Site Number 250007

Nice, 06189, France

Location

Investigational Site Number 250005

Rennes, 35000, France

Location

Investigational Site Number 250003

Saint-Cloud, 92210, France

Location

Investigational Site Number 250009

Saint-Herblain, 44800, France

Location

Investigational Site Number 250012

Saint-Priest-en-Jarez, 42270, France

Location

Investigational Site Number 348001

Budapest, 1134, Hungary

Location

Investigational Site Number 348002

Debrecen, 4032, Hungary

Location

Investigational Site Number 356005

Bangalore, 560054, India

Location

Investigational Site Number 356003

Hyderabad, 500033, India

Location

Investigational Site Number 356004

New Delhi, 110076, India

Location

Investigational Site Number 380001

Aviano, 33081, Italy

Location

Investigational Site Number 380003

Milan, 20133, Italy

Location

Investigational Site Number 380004

Milan, 20141, Italy

Location

Investigational Site Number 380002

Rozzano, 20089, Italy

Location

Investigational Site Number 891001

Belgrade, 11000, Serbia

Location

Investigational Site Number 891002

Kamenitz, 21204, Serbia

Location

Investigational Site Number 724004

Barcelona, 08025, Spain

Location

Investigational Site Number 724001

Madrid, 28040, Spain

Location

Investigational Site Number 724003

Pamplona, 31008, Spain

Location

Investigational Site Number 826001

Bebington, CH63 4JY, United Kingdom

Location

Investigational Site Number 826003

Bristol, BS2 8ED, United Kingdom

Location

Investigational Site Number 826002

Newcastle upon Tyne, NE4 6BE, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 25864104 DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

AC 7700

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2008
• First Posted: June 18, 2008
• Study Start: June 1, 2008
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: December 21, 2015

Record last verified: 2015-11

Locations

BR (8); US (6); FR (11); ES (3); HU (2); GB (3); SE (2); IT (4); IN (3); BE (3)