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

Primary Purpose

Sarcoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
OMBRABULIN (AVE8062)
Placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring tubulin modulator, endothelium, combretastatin, cisplatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 840004
  • Investigational Site Number 840003
  • Investigational Site Number 840005
  • Investigational Site Number 840002
  • Investigational Site Number 840007
  • Investigational Site Number 840001
  • Investigational Site Number 056001
  • Investigational Site Number 056004
  • Investigational Site Number 056005
  • Investigational Site Number 076007
  • Investigational Site Number 076008
  • Investigational Site Number 076003
  • Investigational Site Number 076004
  • Investigational Site Number 076006
  • Investigational Site Number 076002
  • Investigational Site Number 076005
  • Investigational Site Number 076009
  • Investigational Site Number 250008
  • Investigational Site Number 250002
  • Investigational Site Number 250004
  • Investigational Site Number 250001
  • Investigational Site Number 250010
  • Investigational Site Number 250006
  • Investigational Site Number 250007
  • Investigational Site Number 250005
  • Investigational Site Number 250003
  • Investigational Site Number 250012
  • Investigational Site Number 250009
  • Investigational Site Number 348001
  • Investigational Site Number 348002
  • Investigational Site Number 356005
  • Investigational Site Number 356003
  • Investigational Site Number 356004
  • Investigational Site Number 380001
  • Investigational Site Number 380003
  • Investigational Site Number 380004
  • Investigational Site Number 380002
  • Investigational Site Number 891001
  • Investigational Site Number 891002
  • Investigational Site Number 724004
  • Investigational Site Number 724001
  • Investigational Site Number 724003
  • Investigational Site Number 826001
  • Investigational Site Number 826003
  • Investigational Site Number 826002

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Overall survival
Response rate
Safety profile

Full Information

First Posted
May 7, 2008
Last Updated
November 18, 2015
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00699517
Brief Title
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

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
tubulin modulator, endothelium, combretastatin, cisplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
355 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
OMBRABULIN (AVE8062)
Intervention Description
I.V. infusion followed by administration of cisplatin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
I.V. infusion followed by administration of cisplatin
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
until event or study cut-off date (Tumor assessment every 6 weeks)
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
until event or study cut-off date
Title
Response rate
Time Frame
tumor assessment every 6 weeks
Title
Safety profile
Time Frame
assessment every 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 840004
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
Investigational Site Number 840003
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Investigational Site Number 840005
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Investigational Site Number 840002
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Investigational Site Number 840007
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Investigational Site Number 840001
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Investigational Site Number 056001
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Investigational Site Number 056004
City
Haine-Saint-Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Investigational Site Number 056005
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Investigational Site Number 076007
City
Belo Horizonte
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
Investigational Site Number 076008
City
Goiania
ZIP/Postal Code
74070-040
Country
Brazil
Facility Name
Investigational Site Number 076003
City
Ijui
ZIP/Postal Code
98700 000
Country
Brazil
Facility Name
Investigational Site Number 076004
City
Jau
ZIP/Postal Code
17210-120
Country
Brazil
Facility Name
Investigational Site Number 076006
City
Novo Hamburgo
ZIP/Postal Code
93511 970
Country
Brazil
Facility Name
Investigational Site Number 076002
City
Porto Alegre
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Investigational Site Number 076005
City
Porto Alegre
ZIP/Postal Code
90035 003
Country
Brazil
Facility Name
Investigational Site Number 076009
City
Rio De Janeiro
ZIP/Postal Code
20230-130
Country
Brazil
Facility Name
Investigational Site Number 250008
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Investigational Site Number 250002
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Investigational Site Number 250004
City
Lille
ZIP/Postal Code
59010
Country
France
Facility Name
Investigational Site Number 250001
City
Lyon Cedex 03
ZIP/Postal Code
69437
Country
France
Facility Name
Investigational Site Number 250010
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Investigational Site Number 250006
City
Montpellier Cedex
ZIP/Postal Code
34094
Country
France
Facility Name
Investigational Site Number 250007
City
Nice Cedex 02
ZIP/Postal Code
06189
Country
France
Facility Name
Investigational Site Number 250005
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Investigational Site Number 250003
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Investigational Site Number 250012
City
Saint Priest En Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Investigational Site Number 250009
City
Saint-Herblain
ZIP/Postal Code
44800
Country
France
Facility Name
Investigational Site Number 348001
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Investigational Site Number 348002
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Investigational Site Number 356005
City
Bangalore
ZIP/Postal Code
560054
Country
India
Facility Name
Investigational Site Number 356003
City
Hyderabad
ZIP/Postal Code
500033
Country
India
Facility Name
Investigational Site Number 356004
City
New Delhi
ZIP/Postal Code
110076
Country
India
Facility Name
Investigational Site Number 380001
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Investigational Site Number 380003
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Investigational Site Number 380004
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Investigational Site Number 380002
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Investigational Site Number 891001
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Investigational Site Number 891002
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Investigational Site Number 724004
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Investigational Site Number 724001
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Investigational Site Number 724003
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Investigational Site Number 826001
City
Bebington
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Investigational Site Number 826003
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Investigational Site Number 826002
City
Newcastle Upon Tyne
ZIP/Postal Code
NE4 6BE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25864104
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.
Results Reference
derived

Learn more about this trial

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

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