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

A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse

This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer.

Study Overview

• Status: Terminated
• Conditions: Ovarian Cancer
• Intervention / Treatment: Drug: Farletuzumab; Drug: Carboplatin; Drug: Taxane; Drug: Farletuzumab-matched placebo

• Study Type: Interventional
• Enrollment (Actual): 1100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1824
    • Hospital Zonal Especializado en Oncología de Lanus
  • Buenos Aries, Argentina, 1704
    • Consultorios Medicos Privados SA
  • Caba, Argentina, 1180
    • Fundacion Sanatorio Güemes
  • Códoba, Argentina, 5004
    • Clinica Universitaria Reina Fabiola
  • La Plata, Argentina, 1900
    • Instituto Medico Platense
  • La Rioja, Argentina, F5300COE
    • Centro Oncologico Riojano Integral (CORI)
  • Loma Hermosa, Argentina, 1657
    • Hospital Bocalandro
  • Mar Del Plata, Argentina, B7600LTO
    • Centro Oncologico Integral
  • Quilmes, Argentina, B1878DVB
    • CER Instituto Medico
  • San Miguel de Tucuman, Argentina, 4000
    • Centro Médico San Roque
  • San Salvador de Jujuy, Argentina, 4600
    • Centro Medico de Alta Complejidad Cemac
  • Santa Fe, Argentina, S3000FFU
    • ISIS Centro Especializado de LUCE SA
• Australia
  • New South Wales
    • Tweed Heads, New South Wales, Australia, 2485
      • Tweed Hospital
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Queensland
    • Herston, Queensland, Australia, 4029
      • The Royal Brisbane and Women's Hospital
    • South Brisbane, Queensland, Australia, 4101
      • Mater Adult Hospital
  • South Australia
    • North Adelaide, South Australia, Australia, 5006
      • North Adelaide Oncology Clinical Trials
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Sir Charles Gairdner Hospital
• Austria
  • Villach, Austria, 9500
    • Landeskrankenhaus Villach
  • Wien, Austria, 1100
    • Kaiser-Franz-Josef Spital
  • Wien, Austria, 1130
    • Krankenhaus Wien-Hietzing
• Belgium
  • Bruxelles, Belgium, 1000
    • Institut Jules Bordet
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires Saint-luc
  • Gent, Belgium, 9000
    • UZ Gent
  • Kortrijk, Belgium, 8500
    • AZ Groeninge - Campus Maria's Voorzienigheid
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Liège, Belgium, 4000
    • CHU de Liège
  • Wilrijk, Belgium, 2610
    • Sint-Augustinuskliniek
• Brazil
  • Barretos, Brazil, 14784-400
    • Fundação Pio XII - Hospital de Câncer de Barretos
  • Caxias do Sul, Brazil, 95070-560
    • Instituto de Pesquisas Clínicas Para Estudos Multicêntricos
  • Curitiba, Brazil, 80010-030
    • Santa Casa da Misericórdia de Curitiba
  • Fortaleza, Brazil, 60430-230
    • Instituto do Cancer do Ceara - ICC
  • Goiania, Brazil, 74605-160
    • Hosp. Araujo Jorge
  • Ijuí, Brazil, 98700-000
    • Associacao Hospital de Caridade Ijui
  • Itajai, Brazil, 88301-220
    • Clínica de Neoplasias Litoral
  • Jaú, Brazil, 17210-120
    • Hospital Amaral Carvalho
  • Natal, Brazil, 59062-000
    • Liga Norte-Riograndense Contra O Cancer
  • Porto Alegre, Brazil, 90050-170
    • Irmandade Santa Casa de Misericordia de Porto Alegre
  • Porto Alegre, Brazil, 90430-090
    • Clínica de Oncologia de Porto Alegre S/S Ltda
  • Ribeirão Preto, Brazil, 14015-130
    • Instituto Ribeiraopretano de Combate Ao Cancer
  • Rio De Janeiro - RJ, Brazil, 20220-410
    • INCA - Instituto Nacional Do Cancer
  • Rio de Janeiro, Brazil, 22260-020
    • Clinica Oncologistas Associados
  • Salvador, Brazil, 40050-410
    • Hospital Santa Izabel - Santa Casa de Misericórdia da Bahia
  • Salvador, Brazil, 41825-010
    • Clínica AMO - Assistência Multidiciplinar em Oncologia
  • Santo André, Brazil, 09060-650
    • Centro de Estudos de Oncologia da FMABC
  • Santo André, Brazil, 09090-780
    • Saúde ABC Serviços Médicos Hospitalares Ltda
  • São Paulo, Brazil, 01209-000
    • Instituto do Cancer Arnaldo Vieira de Carvalho
  • São Paulo, Brazil, 04551-010
    • Certo Oncologia
  • São Paulo, Brazil, 04583-100
    • Hospital Premier
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N-4N2
      • Tom Baker Cancer Centre
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y5L3
      • Cancer Center for the Southern Interior
    • Surrey, British Columbia, Canada, V3V 1Z2
      • British Columbia Cancer Agency
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • BCCA
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C6Z8
      • The Moncton Hospital
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital
• Chile
  • Santiago, Chile, 7501088
    • Instituto de Terapias Oncologicas
  • Temuco, Chile, 4810469
    • Instituto Clinico Oncologico del Sur
  • Viña del Mar, Chile
    • Instituto Oncologico Ltda.
• France
  • Angers Cedex 9, France, 49933
    • Centre Regional de lutte contre le cancer Paul Papin
  • Le Coudray, France, 28630
    • Centre Hospitalier Louis Pasteur
  • Marseille, France, 13273
    • Institut Paoli Calmettes
  • Paris Cedex 10, France, 75475
    • Hopital Saint Louis
  • Reims, France, 51056
    • Institut Jean Godinot - Centre de lutte contre le cancer
• Germany
  • Berlin, Germany, 13353
    • Charité - Universitätsmedizin Berlin
  • Berlin-Buch, Germany, 13125
    • Helios Klinikum Berlin-Buch
  • Chemnitz, Germany, 09116
    • Klinikum Chemnitz gGmbH
  • Düsseldorf, Germany, 40479
    • Marien-Hospital Akademisches Lehrkrankenhaus
  • Ebersberg, Germany, 85560
    • Frauenarztpraxis Dr. med. Gröll de Rivera
  • Essen, Germany, 45122
    • Universitätsklinikum Essen
  • Frankfurt, Germany, 60488
    • Krankenhaus Nordwest
  • Freiburg, Germany, 79106
    • Universitätsklinikum Freiburg
  • Hamburg, Germany, 22087
    • Kath. Marienkrankenhaus gGmbH
  • Heidelberg, Germany, 69120
    • Universitat Heidelberg
  • Karlsruhe, Germany, 76135
    • St. Vincentius Kliniken Karlsruhe
  • Magdeburg, Germany, 39108
    • Universitätsklinik Magdeburg
  • Mainz, Germany, 55131
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • München, Germany, 80337
    • Klinikum der Universitat Munchen - Innenstadt
  • München, Germany, 80637
    • Rotkreuzklinikum München
  • Rostock, Germany, 18059
    • Klinikum Südstadt Rostock
  • Traunstein, Germany, 83278
    • Klinikum Traunstein
• Greece
  • Athens, Greece, 115 28
    • Alexandra Hospital
  • Athens, Greece, 145 64
    • General Oncology Hospital Kifissias "Oi Agioi Anargyroi"
  • Patras, Greece, 26500
    • University General Hospital of Patras
  • Thessaloniki, Greece, 564 29
    • Papageorgiou General Hospital
  • Crete
    • Heraklion, Crete, Greece, 71110
      • University General Hospital of Heraklion
• Hong Kong
  • Tuen Mun, Hong Kong
    • Tuen Mun Hospital
  • Islands
    • Pokfulam, Islands, Hong Kong
      • Queen Mary Hospital
• Hungary
  • Budapest, Hungary, 1088
    • Semmelweis Egyetem
  • Budapest, Hungary, 1082
    • Semmelweis Egyetem
  • Gyor, Hungary, 9024
    • Petz Aladar Megyei Oktato Korhaz
  • Kecskemét, Hungary, 6000
    • Bács-Kiskun Megyei Önkormányzat Kórháza
  • Miskolc, Hungary, 3526
    • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
  • Szolnok, Hungary, 5004
    • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelőintézet
  • Veszprém, Hungary, 8200
    • Veszprém Megyei Önkormányzat Csolnoky Ferenc Kórház-Rendelöintézet
• India
  • Bangalore, India, 560054
    • M.S Ramaiah Medical College and Teaching Hospital Ethical Review Board
  • Cochin, India, 682026
    • Amrita Institute of Medical Sciences and Research Centre
  • Hyderabaad, India, 500004
    • MNJ Institute of Oncology and Regional Cancer Centre
  • Jaipur, India, 302013
    • SK Soni Hospital
  • Jaipur, India, 302017
    • Bhagwan Mahaveer Cancer Hospital and Research Centre
  • Kochi, India, 682304
    • Lakeshore Hospital
  • Mumbai, India, 400012
    • Tata Memorial hospital
  • Nashik, India, 422005
    • Shatabdi Superspeciality Hospital
  • Nasik, India, 422004
    • Curie Manavata Cancer Centre
  • New Delhi, India, 110029
    • All India Institute of Medical Sciences
  • Trivandrum, India, 695011
    • Regional Cancer Centre
  • Gujarat
    • Gandhinagar, Gujarat, India, 382428
      • Apollo Hospitals International Limited
  • Karnataka
    • Bangalore, Karnataka, India, 560032
      • Kidwai Memorial Institute of Oncology
  • Madhya Pradesh
    • Bhopal, Madhya Pradesh, India, 462001
      • Jawaharlal Nehru Cancer Hospital & Research Centre
  • Maharashtra
    • Pune, Maharashtra, India, 411001
      • Ruby Hall Clinic
    • Pune, Maharashtra, India, 411001
      • Jehangir, Clinical Development Centre
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600100
      • Dr. Kamakshi Memorial Hospital
  • West Bengal
    • Kolkata, West Bengal, India, 700026
      • Chittaranjan National Cancer Institute
• Israel
  • Haifa, Israel, 31096
    • Rambam Medical Center
  • Haifa, Israel, 35152
    • Linn Medical Center, Clalit Health Services
  • Holon, Israel, 58100
    • Wolfson Centre
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center
  • Jerusalem, Israel, 91120
    • Hadassah University Hospital Ein Kerem
  • Kfar Saba, Israel, 44281
    • Meir Medical Center
  • Petach Tikva, Israel, 49100
    • Rabin Medical Center
  • Ramat-Gan, Israel, 52621
    • The Chaim Sheba Medical Center
  • Rehovot, Israel, 76100
    • Kaplan Medical Center
  • Zerifin, Israel, 70300
    • Assaf Harofe Medical Center
• Italy
  • Alessandria, Italy, 15100
    • Azienda Ospedaliera Santi Antonio, Biagio e Cesare Arrigo
  • Bologna, Italy, 40138
    • Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
  • Brescia, Italy, 25124
    • Istituto Ospedaliero Fondazione Poliambulanza
  • Campobasso, Italy, 86100
    • Centro di Ricerca e Formazione ad Alta Tecnologia nelle Scienze Biomediche
  • Catania, Italy, 95126
    • Azienda Ospedaliera Cannizzaro
  • Catania, Italy, 95126
    • Humanitas Centro Catanese Di Oncologia
  • Como, Italy, 22100
    • Azienda Ospedaliera Sant'Anna
  • Faenza, Italy, 48018
    • Ospedale Di Faenza
  • Genova, Italy, 16132
    • Azienda Ospedaliera Universitaria San Martino
  • Lecce, Italy, 73044
    • Presidio Ospedaliero Vito Fazzi
  • Legnago, Italy, 37045
    • Ospedale Mater Salutis ULSS 21 della regione Veneto
  • Meldola, Italy, 47014
    • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST
  • Milano, Italy, 20132
    • Fondazione Centro San Raffaele del Monte Tabor
  • Milano, Italy, 20133
    • Istituto Nazionale dei Tumori
  • Milano, Italy, 20122
    • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
  • Milano, Italy, 20162
    • Azienda Ospedaliera Niguarda Cà Granda
  • Napoli, Italy, 80131
    • Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale"
  • Negrar, Italy, 37024
    • Ospedale Sacro Cuore Don Calabria
  • Padova, Italy, 35128
    • Istituto Oncologico Veneto
  • Perugia, Italy, 06132
    • Ospedale Santa Maria della Misericordia di Perugia
  • Ravenna, Italy, 48100
    • Ospedale Santa Maria delle Croci
  • Reggio Emilia, Italy, 42100
    • Arcispedale Santa Maria Nuova
  • Roma, Italy, 00168
    • Policlinico Universitario "A. GEMELLI"
  • Roma, Italy, 00161
    • Azienda Policlinico Umberto I
  • Udine, Italy, 33100
    • Azienda Ospedaliero-Universitaria Di Udine
  • Pordenone
    • Aviano, Pordenone, Italy, 33081
      • Centro Di Riferimento Oncologico
• Japan
  • Akashi, Japan
  • Amagasaki, Japan
  • Chiba, Japan
  • Fukuoka, Japan
  • Hidaka, Japan
  • Hiroshima, Japan
  • Kagoshima, Japan
  • Kashiwa, Japan
  • Kawasaki, Japan
  • Koto-Ku, Japan
  • Kumamoto, Japan
  • Kure, Japan
  • Kurume, Japan
  • Matsuyama, Japan
  • Minato-Ku, Japan
  • Morioka, Japan
  • Nagoya, Japan
  • Nakano-Ku, Japan
  • Niigata, Japan
  • Okayama, Japan
  • Osaka, Japan
  • Osakasayama, Japan
  • Sapporo, Japan
  • Sendai, Japan
  • Shinjuku-Ku, Japan
  • Sunto-Gun, Japan
  • Tsu, Japan
  • Tsukuba, Japan
  • Yamagata, Japan
  • Yonago, Japan
• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of, 410-769
    • National Cancer Center
  • In Cheon, Korea, Republic of, 405760
    • Gachon University Gil Medical Center
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center
  • Seoul, Korea, Republic of, 135710
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 100380
    • Cheil General Hospital & Women's Healthcare Center
  • Seoul, Korea, Republic of, 110-744
    • Seoul national univercity hospital
  • Seoul, Korea, Republic of, 120752
    • Severance hospital, Yonsei university college of medicine
• Mexico
  • Colima, Mexico, 3402
    • Union Medica Quirurgica de Colima
  • Morelia, Mexico, 58000
    • Triva Investigaciones Medicas Sociedad Anónima de Capital Variable
  • Veracruz, Mexico, 91700
    • Hospital Regional de Veracruz
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • VU Medisch Centrum
  • Dordrecht, Netherlands, 3318 AT
    • Albert Schweitzer Ziekenhuis
  • Maastricht, Netherlands, 6229 HX
    • Academisch Ziekenhuis Maastricht
  • Sittard-Geleen, Netherlands, 6162 BG
    • Orbis Medisch Centrum
• Philippines
  • Cebu, Philippines, 6000
    • Cebu Gynecologic Cancer Care Clinic
  • Manila, Philippines, 1000
    • Manila Doctors Hospital
  • Pasay City, Philippines, 1300
    • San Juan De Dios Hospital
  • Quezon City, Philippines, 1102
    • St. Luke's Medical Center
  • Quezon City, Philippines, 1112
    • National Kidney and Transplant Institute
  • Cebu
    • Cebu City, Cebu, Philippines, 6000
      • Perpetual Succour Hospital
• Poland
  • Bialystok, Poland, 15-027
    • Bialostockie Centrum Onkologii
  • Gdansk, Poland, 80-219
    • Wojewodzkie Centrum Onkologii
  • Gliwice, Poland, 44-100
    • Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie oddzial w Gliwicach
  • Lodz, Poland, 93-509
    • Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
  • Lublin, Poland, 20-090
    • Centrum Onkologii Ziemi Lubelskiej
  • Olsztyn, Poland, 10-228
    • Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii
  • Olsztyn, Poland, 10-513
    • Olsztynski Osrodek Onkologiczny "Kopernik" Sp. z o.o.
  • Poznan, Poland, 61-866
    • Wielkopolskie Centrum Onkologii
  • Poznan, Poland, 61-878
    • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Pozna
  • Rybnik, Poland, 44-200
    • SPZOZ Wojewodzki Szpital Specjalistyczny nr 3
  • Szczecin, Poland, 70-111
    • Samodzielny Publiczny Szpital Kliniczny nr 2 PAM w Szczecinie
  • Warszawa, Poland, 04-141
    • Wojskowy Instytut Medyczny
• Portugal
  • Coimbra, Portugal, 3000-075
    • Hospitais da universidade de Coimbra
  • Coimbra, Portugal, 3000-075
    • Instituto Português de Oncologia Francisco Gentil, Centro Regional de Oncologia de Coimbra, EPE
  • Lisboa, Portugal, 1099-023
    • Instituto Portugues de Oncologia de Lisboa Francisco Gentil (IPOLFG, EPE)
  • Porto, Portugal, 4200-319
    • Hospital de Sao Joao
  • Porto, Portugal, 4200-072
    • Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE)
• Russian Federation
  • Kursk, Russian Federation, 305035
    • Kursk Regional Oncology Centre
  • Moscow, Russian Federation, 115478
    • Russian Oncology Research Center named after N.N. Blokhin
  • Moscow, Russian Federation, 115478
    • Russian Oncology Research Center
  • Moscow, Russian Federation, 125284
    • Moscow Research Oncology Institute n.a. P.A.Gertsen
  • Obninsk, Russian Federation, 249036
    • Medical Radiology Research Center of RAMS
  • Ryazan, Russian Federation, 390011
    • Ryazan Regional clinical oncology dispensary
  • St. Petersburg, Russian Federation, 198255
    • City Clinical Oncology Dispensary
  • Ufa, Russian Federation, 450054
    • Republican Clinical Oncology Center of Bashkortostan Republic Ministry of Healthcare
• Singapore
  • Singapore, Singapore, 229899
    • KK Women's and Children's Hospital
  • Singapore, Singapore, 119074
    • National University Hospital
  • Singapore, Singapore, 169610
    • National Cancer Centre
• Spain
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Andalucía
    • Córdoba, Andalucía, Spain, 14004
      • Hospital Universitario Reina Sofia
    • Sevilla, Andalucía, Spain, 41013
      • Hospital Virgen Del Rocio
  • Baleares
    • Palma de Mallorca, Baleares, Spain, 07198
      • Hospital Son Llatzer
  • Cataluna
    • Barcelona, Cataluna, Spain, 08035
      • Hospital Universitario Vall d'Hebron
  • Cataluña
    • Barcelona, Cataluña, Spain, 08036
      • Hospital Clinic i Provincial
    • Mataró, Cataluña, Spain, 08034
      • Hospital de Mataró
    • Sabadell, Cataluña, Spain, 08208
      • Corporacio Sanitaria Parc Tauli
    • Terrassa, Cataluña, Spain, 08221
      • Hospital Mútua de Terrassa
  • Comunidad Valenciana
    • Elche, Comunidad Valenciana, Spain, 03203
      • Hospital General Universitario de Elche
    • Valencia, Comunidad Valenciana, Spain, 46009
      • Fundación Instituto Valenciano de Oncología
  • Madrid, Communidad De
    • Alcorcón, Madrid, Communidad De, Spain, 28922
      • Fundacion Hospital Alcorcon
    • Madrid, Madrid, Communidad De, Spain, 28007
      • Hospital General Universitario Gregorio Marañon
    • Madrid, Madrid, Communidad De, Spain, 28034
      • Hospital Universitario Ramon y Cajal
    • Madrid, Madrid, Communidad De, Spain, 28041
      • Hospital 12 de Octubre
• Switzerland
  • Zürich, Switzerland, 8091
    • Universität Zürich
• Taiwan
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hosptial
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 104
    • Mackay Memorial Hospital
  • Taipei, Taiwan, 114
    • Tri-Service General Hospital
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Hospital
• Ukraine
  • Cherkasy, Ukraine, 18009
    • Municipal Institution of Cherkasy Regional Counsil "Cherkasy Regional Oncology Dispensary"
  • Chernivtsi, Ukraine, 58013
    • Chernivtsi Regional Clinical Oncology Dispansery
  • Kyiv, Ukraine, 03115
    • Kiev City Oncology Hospital
  • Lutsk, Ukraine, 43018
    • Volyn Regional Oncology Dispensary
• United Kingdom
  • Belfast, United Kingdom, BT9 7AB
    • Belfast City Hospital
  • Cardiff, United Kingdom, CF14 2TL
    • Velindre Hospital
  • Coventry, United Kingdom, CV2 2DX
    • University Hospital Coventry
  • Dundee, United Kingdom, DD1 9SY
    • Ninewells Hospital
  • Glasgow, United Kingdom, G12 0YN
    • Beatson Oncology Centre
  • Leicester, United Kingdom, LE1 5WW
    • Leicester Royal Infirmary
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden Hospital
  • London, United Kingdom, W12 0HS
    • Hammersmith Hospital
  • Plymouth, United Kingdom, PL6 8DH
    • Derriford Hospital
  • Poole, United Kingdom, BH15 2JB
    • Poole Hospital NHS Trust
  • Sheffield, United Kingdom, S10 2SJ
    • Weston Park Hospital
  • Wirral, United Kingdom, CH63 4JY
    • Clatterbridge Centre for Oncology
  • Wolverhampton, United Kingdom, WV10 0QP
    • New Cross Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
    • Huntsville, Alabama, United States, 35801
      • Oncology Specialties, PC
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Arizona Hematology & Oncology Associates
    • Phoenix, Arizona, United States, 85013
      • St. Joseph's Hospital, Barrow Neurology Clinics
    • Tucson, Arizona, United States, 85724
      • Arizona Cancer Center
    • Tucson, Arizona, United States, 85712
      • Arizona Oncology Associates
  • California
    • Burbank, California, United States, 91505
      • Providence St. Joseph Medical Center
    • Greenbrae, California, United States, 94904
      • California Cancer Care, Inc.
    • La Jolla, California, United States, 92093-0698
      • University of California San Diego
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles Medical Center
    • Newport Beach, California, United States, 92663
      • Gynecologic Oncology Associates
    • Sacramento, California, United States, 95817
      • University of California Davis Cancer Center
    • Stanford, California, United States, 94305
      • Stanford University
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Catholic Health Initiatives
    • Denver, Colorado, United States, 80204
      • Denver Health and Hospital Authority
  • Connecticut
    • Stamford, Connecticut, United States, 06902
      • Hematology Oncology P.C.
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Palm Beach Institute of Hematology and Oncology
    • Boynton Beach, Florida, United States, 33435
      • University Cancer Institute
    • Gainesville, Florida, United States, 32605
      • Gainsville Hematology Oncology Associates
    • Jacksonville, Florida, United States, 32207
      • Baptist Cancer Institute
    • Jupiter, Florida, United States, 33458
      • Jupiter Medical center Physician's Group
    • Lake Worth, Florida, United States, 33461
      • Hematology/Oncology Associates
    • Lakeland, Florida, United States, 33805
      • Lakeland Regional Cancer Center
    • Orlando, Florida, United States, 32804
      • Florida Hospital
    • Saint Petersburg, Florida, United States, 33705
      • GulfCoast Oncology
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Healthcare System
    • Tamarac, Florida, United States, 33321
      • Oncology-Hematology Associates of W. Broward P.A.
    • West Palm Beach, Florida, United States, 33401
      • Palm Beach Cancer Institute
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Medical College of Georgia
    • Savannah, Georgia, United States, 31404
      • Memorial Health University Medical Center
  • Hawaii
    • Honolulu, Hawaii, United States, 96826
      • Kapi'olani Medical Center for Women and Children
    • Honolulu, Hawaii, United States, 96819
      • Kaiser Permanente - Moanalua Medical Center
  • Illinois
    • Galesburg, Illinois, United States, 61401
      • Medical & Surgical Specialists, LLC
    • Harvey, Illinois, United States, 60425
      • Ingalls Memorial Hospital
    • Maywood, Illinois, United States, 60153
      • Loyola University Chicago
    • Skokie, Illinois, United States, 60625
      • Midwest Cancer Research Group
    • Winfield, Illinois, United States, 60190
      • Central DuPage Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent Gynecologic Oncology
    • Indianapolis, Indiana, United States, 46237
      • St. Francis Hospital & Health Centers
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Central Baptist Hospital
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
    • Louisville, Kentucky, United States, 40207
      • Norton Healthcare
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Hematology & Oncology Specialists
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Greater Baltimore Medical Center
    • Baltimore, Maryland, United States, 21202
      • Mercy Medical Center
    • Baltimore, Maryland, United States, 21231
      • John Hopkins University
    • Baltimore, Maryland, United States, 21237-3998
      • Weinberg Cancer Institute at Franklin Square
    • Bethesda, Maryland, United States, 20817
      • Center for Cancer and Blood Disorders
    • Frederick, Maryland, United States, 21701
      • Frederick Memorial Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Detroit, Michigan, United States, 48201
      • Barbara Ann Kamanos Cancer Center
    • Grand Rapids, Michigan, United States, 49503
      • Saint Mary's Health Care
    • Lansing, Michigan, United States, 48909
      • Sparrow Regional Cancer Center
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55426
      • Park Nicollet Institute
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Saint Francis Memorial Health Center
    • Kearney, Nebraska, United States, 68847
      • Good Samaritan Hospital Cancer Center
  • New Jersey
    • Camden, New Jersey, United States, 08003
      • The Center for Cancer and Hematologic Disease
    • Denville, New Jersey, United States, 07834
      • Hematology-Oncolgy Associates of NNJ-PA
    • Hackensack, New Jersey, United States, 07601
      • John Theurer Cancer Center at Hackensack University MC
    • Morristown, New Jersey, United States, 07962
      • Morristown Memorial Hospital
    • Voorhees, New Jersey, United States, 08043
      • Cooper Cancer Institute
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico Cancer Center
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • Lake Success, New York, United States, 11042
      • Arena Oncology Associates
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Medical Center
    • Charlotte, North Carolina, United States, 28204
      • Presbyterian Hospital
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Winston-Salem, North Carolina, United States, 27103
      • Piedmont Hematology & Oncology
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Catholic Health Initiatives
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Cleveland
    • Cleveland, Ohio, United States, 44195
      • MetroHealth Medical Center
    • Dayton, Ohio, United States, 45409
      • Miami Valley Hospital
    • Kettering, Ohio, United States, 45429
      • Kettering Medical Center
    • Middletown, Ohio, United States, 45042
      • Signal Point Clinical Research Center, LLC
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Cancer Care Associates
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente Northwest
    • Portland, Oregon, United States, 95213
      • Providence Oncology & Hematology Care
    • Springfield, Oregon, United States, 97477
      • Willamette Valley Cancer Center
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Memorial Hospital
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's Hospital
    • DuBois, Pennsylvania, United States, 15801
      • Oncology Hematology Associates
    • Gettysburg, Pennsylvania, United States, 17325
      • Gettysburg Cancer Center
    • Pittsburgh, Pennsylvania, United States, 15224
      • Western Pennsylvania Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Womens Hospital of UPMC
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Chattanooga's Program in Women's Oncology
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Oncology, PA
    • Bedford, Texas, United States, 76022
      • Texas Oncology, P.A.
    • Dallas, Texas, United States, 75246
      • Baylor Sammons Cancer Center
    • Dallas, Texas, United States, 75231
      • Texas Oncology, PA
    • Harlingen, Texas, United States, 78550
      • International Beneficence Clinical Research, L.L.C.
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston Medical School
    • San Antonio, Texas, United States, 78229
      • South Texas Oncology and Hematology, PA
    • Temple, Texas, United States, 76508
      • Scott and White Memorial Hospital
    • Wichita Falls, Texas, United States, 76310
      • US Oncology Research
  • Utah
    • Ogden, Utah, United States, 84403
      • Northern Utah Associates
    • Salt Lake City, Utah, United States, 84106
      • Utah Cancer Specialists
  • Virginia
    • Annandale, Virginia, United States, 22003
      • Northern Virginia Pelvic Surgery Associates
    • Newport News, Virginia, United States, 23601
      • Peninsula Cancer Institute - Riverside Gynecology Oncology
  • Washington
    • Bremerton, Washington, United States, 98310
      • Harrison Bremerton Hematology and Oncology
    • Everett, Washington, United States, 98201
      • Providence Everett Medical Center
    • Spokane, Washington, United States, 99202
      • Cancer Care Northwest-South
    • Vancouver, Washington, United States, 98684
      • Northwest Cancer Specialists, PC
  • Wisconsin
    • West Allis, Wisconsin, United States, 53227
      • Aurora Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• A histologically or cytologically confirmed diagnosis of non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignancies
• Must have measurable disease by CT or MRI scan
• Must have relapsed radiologically with a randomization date within ≥6 and < 24 months of completion of first-line platinum chemotherapy
• Have been treated with debulking surgery and first-line platinum and taxane based chemotherapy.
• Prior bevacizumbab maintenance is allowed. The last dose of bevacizumab must have been at least 30 days before study Day 1. No cytotoxic maintenance therapy (e.g. taxane) or cancer vaccine therapy is allowed.
• Must be a candidate for carboplatin and taxane therapy
• Neurologic function: neuropathy (sensory and motor) ≤CTCAE Grade 1

Exclusion Criteria:

• Subjects who never responded to first-line platinum-based therapy or whose first relapse occurs <6 months or >24 months from the last platinum therapy
• Subjects who have received other therapy to treat their ovarian cancer since relapse
• Known central nervous system (CNS) tumor involvement
• Evidence of other active invasive malignancy requiring treatment in the past 5 years
• Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA
• Previous treatment with MORAb-003 (farletuzumab)
• Clinical contraindications to use of a taxane

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Farletuzumab (1.25 mg/kg); Participants will receive farletuzumab 1.25 milligram per kilogram (mg/kg) administer as an intravenous (IV) infusion weekly, followed by taxane (paclitaxel [175 milligram per meter square {mg/m^2}] or docetaxel [75 mg/m^2]), administer as IV infusion and followed by carboplatin (to maintain area under curve [AUC] 5-6 milligram per milliliter per minute [mg/mL/minute]), administer as IV infusion, every three weeks, on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg, administer as IV infusion, weekly is given until disease progression.	Drug: Farletuzumab; Farletuzumab IV infusion.; Other Names: MORAb-003; Drug: Carboplatin; Carboplatin IV infusion.; Drug: Taxane; Taxane (Paclitaxel or Docetaxel) IV infusion.
Active Comparator: Farletuzumab (2.5 mg/kg); Participants will receive farletuzumab 2.5 mg/kg administer as an IV infusion weekly, followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg, administer as IV infusion, weekly is given until disease progression.	Drug: Farletuzumab; Farletuzumab IV infusion.; Other Names: MORAb-003; Drug: Carboplatin; Carboplatin IV infusion.; Drug: Taxane; Taxane (Paclitaxel or Docetaxel) IV infusion.
Placebo Comparator: Placebo; Participants will receive farletuzumab-matched placebo (0.9 percent [%] saline) administer as an IV infusion weekly, followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo (0.9% saline), administer as IV infusion, weekly is given until disease progression.	Drug: Carboplatin; Carboplatin IV infusion.; Drug: Taxane; Taxane (Paclitaxel or Docetaxel) IV infusion.; Drug: Farletuzumab-matched placebo; Farletuzumab-matched placebo IV infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression based on the independent radiologic assessment (modified response evaluation criteria in solid tumors [RECIST]), or date of death, whatever the cause. As per RECIST, disease progression was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions. If progression or death was not observed for a participant, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier).	From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS was defined as the time (in months) from the date of randomization to the date of death, due to any cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier.	From the date of randomization until date of death from any cause, or study termination by sponsor, whichever came first (up to 48 months)
Cancer Antigen-125 (CA-125) Progression-Free Survival	CA-125 PFS was defined as the time (in months) from the date of randomization until the date of the first observation of progression based on the Rustin criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, the CA-125 PFS time was censored at the date of the last CA-125 assessment without evidence of progression before the date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Based on Rustin criteria, progressive disease (PD) was a rise in CA125 since beginning of consolidation or previously normal CA125 that rises to greater than or equal to (>=) 2 multiple (*) ULN with either event documented on two occasions or CA-125 >=2*nadir value with either event documented on two occasions.	From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)
Progression-Free Survival Based on Gynecologic Cancer InterGroup (GCIG) Criteria	PFS using GCIG criteria was defined as time (in months) from date of randomization until date of first observation of progression based on GCIG criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, GCIG PFS time was censored at later date of last tumor assessment or CA-125 assessment without evidence of progression before date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Disease progression per GCIG: Participants with elevated CA-125 pretreatment and normalisation of CA-125 must show evidence of CA-125 >=two times ULN on two occasions at least one week apart or participants with elevated CA-125 pretreatment, which never normalises must show evidence of CA-125 >=two times nadir value on two occasions at least one week apart or participants with CA-125 in normal range pretreatment must show evidence of CA-125 >=two times ULN on two occasions at least one week apart.	From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)
Percentage of Participants With Length of Second Remission Greater Than First Remission	Length of first remission was defined as a.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy until date of first relapse (that is, first observation of progression). It was assumed that the date of first relapse was the earlier of progression by CA-125 or progression by radiologic assessment, as judged by the investigator using GCIG criteria. b.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy (used prior to study entry) until date of randomization. The length of the second remission was defined as the period of time (in months) from the date of completion of platinum-based chemotherapy until the first observation of progression based on GCIG criteria. Based on GCIG criteria, disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.	From the date of last dose of platinum-based chemotherapy to date of relapse and date of last dose of platinum-based chemotherapy to first observation of progression (up to 48 months)
Percentage of Participants With Objective Response	Objective response was defined as either a confirmed complete response (CR) or confirmed partial response (PR) as assessed by investigator based on response evaluation criteria in solid tumors version 1.1 (RECIST version 1.1). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.	From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 48 months)
Duration of Tumor Response	Duration of response was defined as the time (in months) from first documentation of objective response (confirmed CR or PR) to the first documentation of objective tumor progression or death due to any cause. Duration of response was derived only for those participants with objective evidence of confirmed CR or PR.	From the first date of confirmed objective response (CR or PR) to first date of progression or death due to any cause (up to 48 months)
Time to Tumor Response (TTR)	Time to tumor response was defined as the time (in months) from the date of randomization to first documentation of objective tumor response. Time to tumor response was derived for those participants with objective evidence of CR or PR.	From the date of randomization to first documentation of objective response (up to 48 months)
Percentage of Participants With Serologic Response (SR)	SR was defined as either normalization, 75% response, or 50% response using the Rustin criteria. Percentage of participants with 50% SR, 75% SR and SR leading to normalization were reported. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of four CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level). A 75% response was established if there had a serial decrease in serum CA-125 levels of 75% over three samples. In both the 50% and 75% response definitions, the final sample was analyzed at least 28 days after the previous sample.	Up to 48 months
Duration of 50% Serologic Response	Duration of SR was defined as the time (in months) from first documentation of response to the first documentation of 50% serologic progression or death due to any cause. For responding participants who did not have serologic progression or did not die and who 1) were either still on study at the time of an analysis, 2) were given antitumor treatment other than study treatment, or 3) were withdrawn from study follow-up before documentation of serologic progression, the duration of SR was censored at the last date the participant was known to be without serologic progression. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of three CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level).	From the first date of documentation of response to first documentation of serologic progression or death due to any cause (up to 48 months)
Time to 50% Serologic Response (TSR)	TSR was defined as the time (in months) from the date of randomization to first documentation of 50% SR. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of three CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level).	From the date of randomization to first documentation of 50% SR (up to 48 months)
Percentage of Participants With Clinical Benefit	Clinical benefit was defined as a confirmed CR or a confirmed PR, or stable disease (SD) using RECIST 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis <10 mm. PR was defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non target lesions.	Up to 48 months
Cmax: Maximum Observed Plasma Concentration of Total Carboplatin and Total Paclitaxel		Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of Total Carboplatin and Total Paclitaxel		Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)
AUC (0-inf): Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time of Total Carboplatin and Total Paclitaxel		Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)
T1/2: Terminal Half-life of Total Carboplatin and Total Paclitaxel		Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)
CL: Clearance of Total Carboplatin and Total Paclitaxel		Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)
Vd: Volume of Distribution of Total Carboplatin and Total Paclitaxel		Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)
Mean Functional Assessment of Cancer Therapy-Ovarian Treatment Outcome Index (FACT-O TOI) Scores	Participant-reported Quality of Life (QoL) was measured using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O), version 4 and reported in the Treatment Outcome Index (TOI) format. TOI is a 26-item subset of the FACT-O questionnaire composed of the raw sum of the physical well-being subscale (7 items), the functional well-being subscale (7 items), and the ovarian cancer subscale (12 items). Each item was scored on a scale of 0 (not at all) to 4 (very much). Some items were reversed scored. Scores from each subsection were summed into one composite score, termed the FACT-O TOI score which ranged from 0 to 104 and a higher score reflected better QoL. As per planned analysis, farletuzumab treatment groups 1.25 mg/kg and 2.5 mg/kg were pooled for the QoL assessment.	Cycle 3, Cycle 6, Cycle 12 (each cycle length=21 days)

Collaborators and Investigators

• Sponsor: Morphotek
• Collaborators: Eisai Europe Ltd. (United Kingdom)

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2009
• Primary Completion (Actual): December 31, 2012
• Study Completion (Actual): April 12, 2013

Study Registration Dates

• First Submitted: February 13, 2009
• First Submitted That Met QC Criteria: February 20, 2009
• First Posted (Estimate): February 24, 2009

Study Record Updates

• Last Update Posted (Actual): December 30, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: ovarian cancer; relapsed ovarian cancer; Platinum-sensitive Ovarian Cancer
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Hypersensitivity; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Antineoplastic Agents; Carboplatin; Taxane; Farletuzumab
• Other Study ID Numbers: MORAb003-004; 2008-005872-29 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No