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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2007-003592-39 |
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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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OMBRABULIN (AVE8062) | Drug | I.V. infusion followed by administration of cisplatin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | until event or study cut-off date (Tumor assessment every 6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | until event or study cut-off date | |
| Response rate | tumor assessment every 6 weeks | |
| Safety profile |
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Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 840004 | Santa Monica | California | 90403 | United States | ||
| Investigational Site Number 840003 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25864104 | Derived | 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. |
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| Placebo |
| Drug |
I.V. infusion followed by administration of cisplatin |
|
| assessment every 3 weeks |
| Orlando |
| Florida |
| 32806 |
| United States |
| Investigational Site Number 840005 | Maywood | Illinois | 60153 | United States |
| Investigational Site Number 840002 | Newark | New Jersey | 07103 | United States |
| Investigational Site Number 840007 | Philadelphia | Pennsylvania | United States |
| Investigational Site Number 840001 | San Antonio | Texas | 78229 | United States |
| Investigational Site Number 056001 | Brussels | 1200 | Belgium |
| Investigational Site Number 056004 | Haine-Saint-Paul | 7100 | Belgium |
| Investigational Site Number 056005 | Liège | 4000 | Belgium |
| Investigational Site Number 076007 | Belo Horizonte | 30130-100 | Brazil |
| Investigational Site Number 076008 | Goiânia | 74070-040 | Brazil |
| Investigational Site Number 076003 | Ijuí | 98700 000 | Brazil |
| Investigational Site Number 076004 | Jaú | 17210-120 | Brazil |
| Investigational Site Number 076006 | Novo Hamburgo | 93511 970 | Brazil |
| Investigational Site Number 076002 | Porto Alegre | 90020-090 | Brazil |
| Investigational Site Number 076005 | Porto Alegre | 90035 003 | Brazil |
| Investigational Site Number 076009 | Rio de Janeiro | 20230-130 | Brazil |
| Investigational Site Number 250008 | Bordeaux | 33076 | France |
| Investigational Site Number 250002 | Dijon | 21079 | France |
| Investigational Site Number 250004 | Lille | 59010 | France |
| Investigational Site Number 250001 | Lyon | 69437 | France |
| Investigational Site Number 250010 | Marseille | 13385 | France |
| Investigational Site Number 250006 | Montpellier | 34094 | France |
| Investigational Site Number 250007 | Nice | 06189 | France |
| Investigational Site Number 250005 | Rennes | 35000 | France |
| Investigational Site Number 250003 | Saint-Cloud | 92210 | France |
| Investigational Site Number 250009 | Saint-Herblain | 44800 | France |
| Investigational Site Number 250012 | Saint-Priest-en-Jarez | 42270 | France |
| Investigational Site Number 348001 | Budapest | 1134 | Hungary |
| Investigational Site Number 348002 | Debrecen | 4032 | Hungary |
| Investigational Site Number 356005 | Bangalore | 560054 | India |
| Investigational Site Number 356003 | Hyderabad | 500033 | India |
| Investigational Site Number 356004 | New Delhi | 110076 | India |
| Investigational Site Number 380001 | Aviano | 33081 | Italy |
| Investigational Site Number 380003 | Milan | 20133 | Italy |
| Investigational Site Number 380004 | Milan | 20141 | Italy |
| Investigational Site Number 380002 | Rozzano | 20089 | Italy |
| Investigational Site Number 891001 | Belgrade | 11000 | Serbia |
| Investigational Site Number 891002 | Kamenitz | 21204 | Serbia |
| Investigational Site Number 724004 | Barcelona | 08025 | Spain |
| Investigational Site Number 724001 | Madrid | 28040 | Spain |
| Investigational Site Number 724003 | Pamplona | 31008 | Spain |
| Investigational Site Number 826001 | Bebington | CH63 4JY | United Kingdom |
| Investigational Site Number 826003 | Bristol | BS2 8ED | United Kingdom |
| Investigational Site Number 826002 | Newcastle upon Tyne | NE4 6BE | United Kingdom |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C400245 | AC 7700 |
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