Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse

PHASE3TerminatedINTERVENTIONAL
Enrollment

1,100

Participants

Timeline

Start Date

April 16, 2009

Primary Completion Date

December 31, 2012

Study Completion Date

April 12, 2013

Conditions
Ovarian Cancer
Interventions
DRUG

Farletuzumab

Farletuzumab IV infusion.

DRUG

Carboplatin

Carboplatin IV infusion.

DRUG

Taxane

Taxane (Paclitaxel or Docetaxel) IV infusion.

DRUG

Farletuzumab-matched placebo

Farletuzumab-matched placebo IV infusion.

Trial Locations (375)

100

National Taiwan University Hospital, Taipei

104

Mackay Memorial Hospital, Taipei

112

Taipei Veterans General Hospital, Taipei

114

Tri-Service General Hospital, Taipei

333

Chang Gung Memorial Hospital, Taoyuan District

704

National Cheng Kung University Hosptial, Tainan City

1000

Institut Jules Bordet, Brussels

Manila Doctors Hospital, Manila

1082

Semmelweis Egyetem, Budapest

1088

Semmelweis Egyetem, Budapest

1100

Kaiser-Franz-Josef Spital, Vienna

1102

St. Luke's Medical Center, Quezon City

1112

National Kidney and Transplant Institute, Quezon City

1130

Krankenhaus Wien-Hietzing, Vienna

1180

Fundación Sanatorio Güemes, CABA

1200

Cliniques Universitaires Saint-Luc, Brussels

1300

San Juan de Dios Hospital, Pasay

1657

Hospital Bocalandro, Loma Hermosa

1704

Consultorios Medicos Privados SA, Buenos Aries

1824

Hospital Zonal Especializado en Oncología de Lanús, Buenos Aires

1900

Instituto Medico Platense, La Plata

2145

Westmead Hospital, Westmead

2485

Tweed Hospital, Tweed Heads

2610

Sint-Augustinuskliniek, Wilrijk

3000

UZ Leuven, Leuven

3402

Union Medica Quirurgica de Colima, Colima

3526

Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház, Miskolc

4000

Centro Médico San Roque, San Miguel de Tucumán

CHU de Liège, Liège

4029

The Royal Brisbane and Women's Hospital, Herston

4101

Mater Adult Hospital, South Brisbane

4600

Centro Medico de Alta Complejidad Cemac, San Salvador de Jujuy

5004

Clinica Universitaria Reina Fabiola, Códoba

Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelöintézet, Szolnok

5006

North Adelaide Oncology Clinical Trials, North Adelaide

6000

Bács-Kiskun Megyei Önkormányzat Kórháza, Kecskemét

Perpetual Succour Hospital, Cebu City

Cebu Gynecologic Cancer Care Clinic, Cebu

6009

Sir Charles Gairdner Hospital, Nedlands

8091

Universität Zürich, Zurich

8200

Veszprém Megyei Önkormányzat Csolnoky Ferenc Kórház-Rendelöintézet, Veszprém

8500

AZ Groeninge - Campus Maria's Voorzienigheid, Kortrijk

9000

UZ Gent, Ghent

9024

Petz Aladár Megyei Oktató Kórház, Győr

9500

Landeskrankenhaus Villach, Villach

10032

Columbia University Medical Center, New York

11042

Arena Oncology Associates, Lake Success

13125

Helios Klinikum Berlin-Buch, Buch

13210

SUNY Upstate Medical University, Syracuse

13273

Institut Paoli Calmettes, Marseille

13353

Charité - Universitätsmedizin Berlin, Berlin

14004

Hospital Universitario Reina Sofia, Córdoba

14263

Roswell Park Cancer Institute, Buffalo

15100

Azienda Ospedaliera Santi Antonio, Biagio e Cesare Arrigo, Alessandria

15213

Magee-Womens Hospital of UPMC, Pittsburgh

15224

Western Pennsylvania Hospital, Pittsburgh

15801

Oncology Hematology Associates, DuBois

16132

Azienda Ospedaliera Universitaria San Martino, Genova

17325

Gettysburg Cancer Center, Gettysburg

18009

"Municipal Institution of Cherkasy Regional Counsil Cherkasy Regional Oncology Dispensary", Cherkasy

18015

St. Luke's Hospital, Bethlehem

18059

Klinikum Südstadt Rostock, Rostock

19001

Abington Memorial Hospital, Abington

20010

Washington Hospital Center, Washington D.C.

20122

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan

20132

Fondazione Centro San Raffaele del Monte Tabor, Milan

20133

Istituto Nazionale dei Tumori, Milan

20162

Azienda Ospedaliera Niguarda Cà Granda, Milan

20817

Center for Cancer and Blood Disorders, Bethesda

21202

Mercy Medical Center, Baltimore

21204

Greater Baltimore Medical Center, Baltimore

21231

John Hopkins University, Baltimore

21701

Frederick Memorial Hospital, Frederick

22003

Northern Virginia Pelvic Surgery Associates, Annandale

22087

Kath. Marienkrankenhaus gGmbH, Hamburg

22100

Azienda Ospedaliera Sant'Anna, Como

23601

Peninsula Cancer Institute - Riverside Gynecology Oncology, Newport News

25124

Istituto Ospedaliero Fondazione Poliambulanza, Brescia

26500

University General Hospital of Patras, Pátrai

27103

Piedmont Hematology & Oncology, Winston-Salem

27710

Duke University Medical Center, Durham

28007

Hospital General Universitario Gregorio Marañon, Madrid

28034

Hospital Universitario Ramón y Cajal, Madrid

28040

Hospital Clinico San Carlos, Madrid

28041

Hospital 12 de Octubre, Madrid

28204

Carolinas Medical Center, Charlotte

Presbyterian Hospital, Charlotte

28630

Centre Hospitalier Louis Pasteur, Le Coudray

28922

Fundacion Hospital Alcorcon, Alcorcón

29425

Medical University of South Carolina, Charleston

30912

Medical College of Georgia, Augusta

31096

Rambam Medical Center, Haifa

31404

Memorial Health University Medical Center, Savannah

32207

Baptist Cancer Institute, Jacksonville

32605

Gainsville Hematology Oncology Associates, Gainesville

32804

Florida Hospital, Orlando

33081

Centro di Riferimento Oncologico, Aviano

33100

Azienda Ospedaliero-Universitaria di Udine, Udine

33321

Oncology-Hematology Associates of W. Broward P.A., Tamarac

33401

Palm Beach Cancer Institute, West Palm Beach

33435

Palm Beach Institute of Hematology and Oncology, Boynton Beach

University Cancer Institute, Boynton Beach

33458

Jupiter Medical center Physician's Group, Jupiter

33461

Hematology/Oncology Associates, Lake Worth

33705

Gulfcoast Oncology, St. Petersburg

33805

Lakeland Regional Cancer Center, Lakeland

34239

Sarasota Memorial Healthcare System, Sarasota

35128

Istituto Oncologico Veneto, Padua

35152

Linn Medical Center, Clalit Health Services, Haifa

35233

University Of Alabama At Birmingham, Birmingham

35801

Oncology Specialties, PC, Huntsville

37024

Ospedale Sacro Cuore Don Calabria, Negrar

37045

Ospedale Mater Salutis ULSS 21 della regione Veneto, Legnago

37232

Vanderbilt University Medical Center, Nashville

37403

Chattanooga's Program in Women's Oncology, Chattanooga

39108

Universitätsklinik Magdeburg, Magdeburg

40138

Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi, Bologna

40202

University of Louisville, Louisville

40207

Norton Healthcare, Louisville

40479

Marien-Hospital Akademisches Lehrkrankenhaus, Düsseldorf

40503

Central Baptist Hospital, Lexington

41013

Hospital Virgen del Rocio, Seville

42100

Arcispedale Santa Maria Nuova, Reggio Emilia

43018

Volyn Regional Oncology Dispensary, Lutsk

44106

University Hospitals of Cleveland, Cleveland

44195

MetroHealth Medical Center, Cleveland

44281

Meir Medical Center, Kfar Saba

45042

Signal Point Clinical Research Center, LLC, Middletown

45122

Universitätsklinikum Essen, Essen

45220

Catholic Health Initiatives, Cincinnati

45409

Miami Valley Hospital, Dayton

45429

Kettering Medical Center, Kettering

46009

Fundación Instituto Valenciano de Oncología, Valencia

46237

St. Francis Hospital & Health Centers, Indianapolis

46260

St. Vincent Gynecologic Oncology, Indianapolis

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST, Meldola

48018

Ospedale di Faenza, Faenza

48100

Ospedale Santa Maria delle Croci, Ravenna

48201

Barbara Ann Kamanos Cancer Center, Detroit

48202

Henry Ford Health System, Detroit

48909

Sparrow Regional Cancer Center, Lansing

49100

Rabin Medical Center, Petah Tikva

49503

Saint Mary's Health Care, Grand Rapids

49933

Centre Régional de lutte contre le cancer Paul Papin, Angers

51056

Institut Jean Godinot - Centre de lutte contre le cancer, Reims

52621

The Chaim Sheba Medical Center, Ramat Gan

53227

Aurora Health Care, West Allis

55131

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz

55426

Park Nicollet Institute, Saint Louis Park

58000

Triva Investigaciones Medicas Sociedad Anónima de Capital Variable, Morelia

58013

Chernivtsi Regional Clinical Oncology Dispansery, Chernivtsi

58100

Wolfson Centre, Holon

60153

Loyola University Chicago, Maywood

60190

Central DuPage Hospital, Winfield

60425

Ingalls Memorial Hospital, Harvey

60488

Krankenhaus Nordwest, Frankfurt

60625

Midwest Cancer Research Group, Skokie

61401

Medical & Surgical Specialists, LLC, Galesburg

68803

Saint Francis Memorial Health Center, Grand Island

68847

Good Samaritan Hospital Cancer Center, Kearney

69120

Universität Heidelberg, Heidelberg

70006

Hematology & Oncology Specialists, Metairie

70300

Assaf Harofe Medical Center, Ẕerifin

71110

University General Hospital of Heraklion, Heraklion

73044

Presidio Ospedaliero Vito Fazzi, Lecce

74136

Cancer Care Associates, Tulsa

75231

Texas Oncology, PA, Dallas

75246

Baylor Sammons Cancer Center, Dallas

75475

Hôpital Saint Louis, Paris

76022

Texas Oncology, P.A., Bedford

76100

Kaplan Medical Center, Rehovot

76135

St. Vincentius Kliniken Karlsruhe, Karlsruhe

76310

US Oncology Research, Wichita Falls

76508

Scott and White Memorial Hospital, Temple

77030

University of Texas Health Science Center at Houston Medical School, Houston

78229

South Texas Oncology and Hematology, PA, San Antonio

78550

International Beneficence Clinical Research, L.L.C., Harlingen

78705

Texas Oncology, PA, Austin

79106

Universitätsklinikum Freiburg, Freiburg im Breisgau

80045

University of Colorado, Aurora

80131

"Istituto Nazionale per lo studio e la cura dei tumori Fondazione Giovanni Pascale", Napoli

80204

Denver Health and Hospital Authority, Denver

80337

Klinikum der Universität München - Innenstadt, München

80637

Rotkreuzklinikum München, München

80907

Catholic Health Initiatives, Colorado Springs

83278

Klinikum Traunstein, Traunstein

84106

Utah Cancer Specialists, Salt Lake City

84403

Northern Utah Associates, Ogden

85012

Arizona Hematology & Oncology Associates, Phoenix

85013

St. Joseph's Hospital, Barrow Neurology Clinics, Phoenix

85560

Frauenarztpraxis Dr. med. Gröll de Rivera, Ebersberg

85712

Arizona Oncology Associates, Tucson

85724

Arizona Cancer Center, Tucson

86100

Centro di Ricerca e Formazione ad Alta Tecnologia nelle Scienze Biomediche, Campobasso

87106

University of New Mexico Cancer Center, Albuquerque

90095

University of California Los Angeles Medical Center, Los Angeles

91031

Shaare Zedek Medical Center, Jerusalem

91120

Hadassah University Hospital Ein Kerem, Jerusalem

91505

Providence St. Joseph Medical Center, Burbank

91700

Hospital Regional de Veracruz, Veracruz

92663

Gynecologic Oncology Associates, Newport Beach

94305

Stanford University, Stanford

94904

California Cancer Care, Inc., Greenbrae

95126

Azienda Ospedaliera Cannizzaro, Catania

Humanitas Centro Catanese di Oncologia, Catania

95213

Providence Oncology & Hematology Care, Portland

95817

University of California Davis Cancer Center, Sacramento

96819

Kaiser Permanente - Moanalua Medical Center, Honolulu

96826

Kapi'olani Medical Center for Women and Children, Honolulu

97227

Kaiser Permanente Northwest, Portland

97239

Oregon Health & Science University, Portland

97477

Willamette Valley Cancer Center, Springfield

98201

Providence Everett Medical Center, Everett

98310

Harrison Bremerton Hematology and Oncology, Bremerton

98684

Northwest Cancer Specialists, PC, Vancouver

99202

Cancer Care Northwest-South, Spokane

100380

Cheil General Hospital & Women's Healthcare Center, Seoul

110029

All India Institute of Medical Sciences, New Delhi

115478

Russian Oncology Research Center named after N.N. Blokhin, Moscow

Russian Oncology Research Center, Moscow

119074

National University Hospital, Singapore

120752

Severance Hospital, Yonsei University College of Medicine, Seoul

125284

Moscow Research Oncology Institute n.a. P.A.Gertsen, Moscow

135710

Samsung Medical Center, Seoul

169610

National Cancer Centre, Singapore

198255

City Clinical Oncology Dispensary, Saint Petersburg

229899

KK Women's and Children's Hospital, Singapore

249036

Medical Radiology Research Center of RAMS, Obninsk

302013

SK Soni Hospital, Jaipur

302017

Bhagwan Mahaveer Cancer Hospital and Research Centre, Jaipur

305035

Kursk Regional Oncology Centre, Kursk

382428

Apollo Hospitals International Limited, Gandhinagar

390011

Ryazan Regional Clinical Oncology Dispensary, Ryazan

400012

Tata Memorial Hospital, Mumbai

405760

Gachon University Gil Medical Center, Incheon

411001

Jehangir, Clinical Development Centre, Pune

Ruby Hall Clinic, Pune

422004

Curie Manavata Cancer Centre, Nashik

422005

Shatabdi Superspeciality Hospital, Nashik

450054

Republican Clinical Oncology Center of Bashkortostan Republic Ministry of Healthcare, Ufa

462001

Jawaharlal Nehru Cancer Hospital & Research Centre, Bhopal

500004

MNJ Institute of Oncology and Regional Cancer Centre, Hyderabaad

560032

Kidwai Memorial Institute of Oncology, Bangalore

560054

M.S Ramaiah Medical College and Teaching Hospital Ethical Review Board, Bangalore

600100

Dr. Kamakshi Memorial Hospital, Chennai

682026

Amrita Institute of Medical Sciences and Research Centre, Kochi

682304

Lakeshore Hospital, Kochi

695011

Regional Cancer Centre, Trivandrum

700026

Chittaranjan National Cancer Institute, Kolkata

4810469

Instituto Clínico Oncológico del Sur, Temuco

7501088

Instituto de Terapias Oncologicas, Santiago

92093-0698

University of California San Diego, La Jolla

06902

Hematology Oncology P.C., Stamford

21237-3998

Weinberg Cancer Institute at Franklin Square, Baltimore

08003

The Center for Cancer and Hematologic Disease, Camden

07834

Hematology-Oncolgy Associates of NNJ-PA, Denville

07601

John Theurer Cancer Center at Hackensack University MC, Hackensack

07962

Morristown Memorial Hospital, Morristown

08043

Cooper Cancer Institute, Voorhees Township

F5300COE

Centro Oncologico Riojano Integral (CORI), La Rioja

B7600LTO

Centro Oncologico Integral, Mar del Plata

B1878DVB

CER Instituto Medico, Quilmes

S3000FFU

ISIS Centro Especializado de LUCE SA, Santa Fe

14784-400

Fundação Pio XII - Hospital de Câncer de Barretos, Barretos

95070-560

Instituto de Pesquisas Clínicas para Estudos Multicêntricos, Caxias do Sul

80010-030

Santa Casa da Misericórdia de Curitiba, Curitiba

60430-230

Instituto do Câncer do Ceará - ICC, Fortaleza

74605-160

Hosp. Araujo Jorge, Goiânia

98700-000

Associação Hospital de Caridade Ijuí, Ijuí

88301-220

Clinica de Neoplasias Litoral, Itajaí

17210-120

Hospital Amaral Carvalho, Jaú

59062-000

Liga Norte-Riograndense Contra o Câncer, Natal

90050-170

Irmandade Santa Casa de Misericórdia de Porto Alegre, Porto Alegre

90430-090

Clínica de Oncologia de Porto Alegre S/S Ltda, Porto Alegre

14015-130

Instituto Ribeirãopretano de Combate ao Câncer, Ribeirão Preto

22260-020

Clínica Oncologistas Associados, Rio de Janeiro

20220-410

INCA - Instituto Nacional do Câncer, Rio de Janeiro - RJ

40050-410

Hospital Santa Izabel - Santa Casa de Misericordia da Bahia, Salvador

41825-010

Clínica AMO - Assistência Multidiciplinar em Oncologia, Salvador

09060-650

Centro de Estudos de Oncologia da FMABC, Santo André

09090-780

Saúde ABC Serviços Médicos Hospitalares Ltda, Santo André

01209-000

Instituto do Câncer Arnaldo Vieira de Carvalho, São Paulo

04551-010

Certo Oncologia, São Paulo

04583-100

Hospital Premier, São Paulo

T2N-4N2

Tom Baker Cancer Centre, Calgary

V1Y5L3

Cancer Center For The Southern Interior, Kelowna

V3V 1Z2

British Columbia Cancer Agency, Surrey

V5Z 4E6

BCCA, Vancouver

E1C6Z8

The Moncton Hospital, Moncton

K1H 8L6

Ottawa Hospital, Ottawa

Unknown

Instituto Oncologico Ltda., Viña del Mar

Queen Mary Hospital, Pokfulam

Tuen Mun Hospital, Tuenmen

Akashi

Amagasaki

Chiba

Fukuoka

Hidaka

Hiroshima

Kagoshima

Kashiwa

Kawasaki

Kōtoku

Kumamoto

Kure

Kurume

Matsuyama

Minatoku

Morioka

Nagoya

Nakano

Niigata

Okayama

Osaka

Sapporo

Sayama

Sendai

Shinjuku-Ku

Sunto-Gun

Tsu

Tsukuba

Yamagata

Yonago

09116

Klinikum Chemnitz gGmbH, Chemnitz

115 28

Alexandra Hospital, Athens

145 64

"General Oncology Hospital Kifissias Oi Agioi Anargyroi", Athens

564 29

Papageorgiou General Hospital, Thessaloniki

06132

Ospedale Santa Maria della Misericordia di Perugia, Perugia

00161

Azienda Policlinico Umberto I, Roma

00168

"Policlinico Universitario A. Gemelli", Roma

1081 HV

VU Medisch Centrum, Amsterdam

3318 AT

Albert Schweitzer Ziekenhuis, Dordrecht

6229 HX

Academisch Ziekenhuis Maastricht, Maastricht

6162 BG

Orbis Medisch Centrum, Sittard-Geleen

15-027

Bialostockie Centrum Onkologii, Bialystok

80-219

Wojewodzkie Centrum Onkologii, Gdansk

44-100

Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie oddzial w Gliwicach, Gliwice

93-509

Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi, Lodz

20-090

Centrum Onkologii Ziemi Lubelskiej, Lublin

10-228

Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii, Olsztyn

10-513

"Olsztynski Osrodek Onkologiczny Kopernik Sp. z o.o.", Olsztyn

61-866

Wielkopolskie Centrum Onkologii, Poznan

61-878

Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Pozna, Poznan

44-200

SPZOZ Wojewodzki Szpital Specjalistyczny nr 3, Rybnik

70-111

Samodzielny Publiczny Szpital Kliniczny nr 2 PAM w Szczecinie, Szczecin

04-141

Wojskowy Instytut Medyczny, Warsaw

3000-075

Hospitais da Universidade de Coimbra, Coimbra

Instituto Português de Oncologia Francisco Gentil, Centro Regional de Oncologia de Coimbra, EPE, Coimbra

1099-023

Instituto Portugues de Oncologia de Lisboa Francisco Gentil (IPOLFG, EPE), Lisbon

4200-072

Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE), Porto

4200-319

Hospital de São João, Porto

410-769

National Cancer Center, Gyeonggi-do

110-744

Seoul national univercity hospital, Seoul

138-736

Asan Medical Center, Seoul

07198

Hospital Son Llatzer, Palma de Mallorca

08035

Hospital Universitario Vall D'Hebron, Barcelona

08036

Hospital Clinic i Provincial, Barcelona

08034

Hospital de Mataró, Mataró

08208

Corporació Sanitaria Parc Taulí, Sabadell

08221

Hospital Mutua de Terrassa, Terrassa

03203

Hospital General Universitario de Elche, Elche

03115

Kiev City Oncology Hospital, Kyiv

BT9 7AB

Belfast City Hospital, Belfast

CF14 2TL

Velindre Hospital, Cardiff

CV2 2DX

University Hospital Coventry, Coventry

DD1 9SY

Ninewells Hospital, Dundee

G12 0YN

Beatson Oncology Centre, Glasgow

LE1 5WW

Leicester Royal Infirmary, Leicester

SW3 6JJ

Royal Marsden Hospital, London

W12 0HS

Hammersmith Hospital, London

CH63 4JY

Clatterbridge Centre For Oncology, Metropolitan Borough of Wirral

PL6 8DH

Derriford Hospital, Plymouth

BH15 2JB

Poole Hospital NHS Trust, Poole

S10 2SJ

Weston Park Hospital, Sheffield

WV10 0QP

New Cross Hospital, Wolverhampton

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Eisai Europe Ltd. (United Kingdom)

INDUSTRY

lead

Morphotek

INDUSTRY