An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

672

Participants

Timeline

Start Date

April 30, 2005

Primary Completion Date

November 30, 2010

Study Completion Date

November 30, 2010

Conditions
Ovarian Cancer
Interventions
DRUG

Trabectedin

Type=exact number, unit=mg/m2, number=1.1, form=solution, route=IV. Trabectedin will be administered over 3 hours every 3 weeks.

DRUG

DOXIL

Type=exact number, unit=mg/m2, number=30, 50, form=solution, route=IV. DOXIL will be administered over 90 minutes every 4 weeks when administered alone (monotherapy) and every 3 weeks when administered with trabectedin.

DRUG

Dexamethasone

Type=exact number, unit=mg, number=20, form=solution, route=IV. Dexamethasone or its equivalent will be administered over 30 minutes prior to the DOXIL infusion.

Trial Locations (111)

Unknown

Mobile

Tucson

Los Angeles

Newport Beach

Orange

Englewood

Stamford

Tampa

Coeur d'Alene

Louisville

New Orleans

Boston

Minneapolis

St Louis

Morristown

New York

Charlotte

Greenville

Winston-Salem

Cleveland

Toledo

Portland

Pittsburgh

Greenville

Chattanooga

Nashville

Dallas

Galveston

Buenos Aires

Mendoza

Sante Fe

Adelaide

Bentleigh

Douglas

St Leonards

Toorak Gardens

Edegem

Hasselt

Leuven

Wilrijk

Barretos

Belo Horizonte

Cerqueira César

Londrina

Santo André

São Paulo

Calgary

Edmonton

Ottawa

Montreal

Québec

Reneca

Santiago

Beijing

Guangzhou

Hangzhou

Jinan

Shanghai

Chartres

Paris

Pierre-Bénite

Düsseldorf

Heidelberg

Jena

Karlsruhe

Mainz

Villingen-Schwenningen

Wilhelmshaven

Chai Wan

Hong Kong

Shatin

Amsterdam

Enschede

Groningen

Maastricht

Gdansku

Gliwice

Krakow

Olsztyn

Poznan

Warszawa Poland

Wroclaw

Chelyabinsk

Moscow

Obninsk, Kaluga Region

Orenburg

Saint Petersburg

Samara

Singapore

Seoul

Barcelona

Girona

Guadalajara

L'Hospitalet de Llobregat

Madrid

Marañón

Valencia

Zaragoza

Gothenburg

Umeå

Uppsala

Kaohsiung County

Taipei

Taoyuan District

Birmingham

Edinburgh

Leicester

London

Nottingham

Poole

Sheffield

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

PharmaMar

INDUSTRY

lead

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY