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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00849667
• Other study ID #: MORAb003-004
• Secondary ID: 2008-005872-29
• Status: Terminated
• Phase: Phase 3
• Start date: April 16, 2009
• Est. completion date: April 12, 2013

Study information

• Verified date: November 2022
• Source: Morphotek
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1100
• Est. completion date: April 12, 2013
• Est. primary completion date: December 31, 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Hypersensitivity
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Farletuzumab
Farletuzumab IV infusion.
• Carboplatin
Carboplatin IV infusion.
• Taxane
Taxane (Paclitaxel or Docetaxel) IV infusion.
• Farletuzumab-matched placebo
Farletuzumab-matched placebo IV infusion.

Locations

Country	Name	City	State
Argentina	Hospital Zonal Especializado en Oncología de Lanús	Buenos Aires
Argentina	Consultorios Medicos Privados SA	Buenos Aries
Argentina	Fundación Sanatorio Güemes	Caba
Argentina	Clinica Universitaria Reina Fabiola	Códoba
Argentina	Instituto Medico Platense	La Plata
Argentina	Centro Oncologico Riojano Integral (CORI)	La Rioja
Argentina	Hospital Bocalandro	Loma Hermosa
Argentina	Centro Oncologico Integral	Mar Del Plata
Argentina	CER Instituto Medico	Quilmes
Argentina	Centro Médico San Roque	San Miguel de Tucuman
Argentina	Centro Medico de Alta Complejidad Cemac	San Salvador de Jujuy
Argentina	ISIS Centro Especializado de LUCE SA	Santa Fe
Australia	The Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	North Adelaide Oncology Clinical Trials	North Adelaide	South Australia
Australia	Mater Adult Hospital	South Brisbane	Queensland
Australia	Tweed Hospital	Tweed Heads	New South Wales
Australia	Westmead Hospital	Westmead	New South Wales
Austria	Landeskrankenhaus Villach	Villach
Austria	Kaiser-Franz-Josef Spital	Wien
Austria	Krankenhaus Wien-Hietzing	Wien
Belgium	Cliniques Universitaires Saint-Luc	Bruxelles
Belgium	Institut Jules Bordet	Bruxelles
Belgium	UZ Gent	Gent
Belgium	AZ Groeninge - Campus Maria's Voorzienigheid	Kortrijk
Belgium	UZ Leuven	Leuven
Belgium	CHU de Liège	Liège
Belgium	Sint-Augustinuskliniek	Wilrijk
Brazil	Fundação Pio XII - Hospital de Câncer de Barretos	Barretos
Brazil	Instituto de Pesquisas Clínicas para Estudos Multicêntricos	Caxias do Sul
Brazil	Santa Casa da Misericórdia de Curitiba	Curitiba
Brazil	Instituto do Câncer do Ceará - ICC	Fortaleza
Brazil	Hosp. Araujo Jorge	Goiania
Brazil	Associação Hospital de Caridade Ijuí	Ijuí
Brazil	Clinica de Neoplasias Litoral	Itajai
Brazil	Hospital Amaral Carvalho	Jaú
Brazil	Liga Norte-Riograndense Contra o Câncer	Natal
Brazil	Clínica de Oncologia de Porto Alegre S/S Ltda	Porto Alegre
Brazil	Irmandade Santa Casa de Misericórdia de Porto Alegre	Porto Alegre
Brazil	Instituto Ribeirãopretano de Combate ao Câncer	Ribeirão Preto
Brazil	Clínica Oncologistas Associados	Rio de Janeiro
Brazil	INCA - Instituto Nacional do Câncer	Rio De Janeiro - RJ
Brazil	Clínica AMO - Assistência Multidiciplinar em Oncologia	Salvador
Brazil	Hospital Santa Izabel - Santa Casa de Misericordia da Bahia	Salvador
Brazil	Centro de Estudos de Oncologia da FMABC	Santo André
Brazil	Saúde ABC Serviços Médicos Hospitalares Ltda	Santo André
Brazil	Certo Oncologia	São Paulo
Brazil	Hospital Premier	São Paulo
Brazil	Instituto do Câncer Arnaldo Vieira de Carvalho	São Paulo
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cancer Center For The Southern Interior	Kelowna	British Columbia
Canada	The Moncton Hospital	Moncton	New Brunswick
Canada	Ottawa Hospital	Ottawa	Ontario
Canada	British Columbia Cancer Agency	Surrey	British Columbia
Canada	BCCA	Vancouver	British Columbia
Chile	Instituto de Terapias Oncologicas	Santiago
Chile	Instituto Clínico Oncológico del Sur	Temuco
Chile	Instituto Oncologico Ltda.	Viña del Mar
France	Centre Régional de lutte contre le cancer Paul Papin	Angers Cedex 9
France	Centre Hospitalier Louis Pasteur	Le Coudray
France	Institut Paoli Calmettes	Marseille
France	Hôpital Saint Louis	Paris Cedex 10
France	Institut Jean Godinot - Centre de lutte contre le cancer	Reims
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Helios Klinikum Berlin-Buch	Berlin-Buch
Germany	Klinikum Chemnitz gGmbH	Chemnitz
Germany	Marien-Hospital Akademisches Lehrkrankenhaus	Düsseldorf
Germany	Frauenarztpraxis Dr. med. Gröll de Rivera	Ebersberg
Germany	Universitätsklinikum Essen	Essen
Germany	Krankenhaus Nordwest	Frankfurt
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Kath. Marienkrankenhaus gGmbH	Hamburg
Germany	Universität Heidelberg	Heidelberg
Germany	St. Vincentius Kliniken Karlsruhe	Karlsruhe
Germany	Universitätsklinik Magdeburg	Magdeburg
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz
Germany	Klinikum der Universität München - Innenstadt	München
Germany	Rotkreuzklinikum München	München
Germany	Klinikum Südstadt Rostock	Rostock
Germany	Klinikum Traunstein	Traunstein
Greece	Alexandra Hospital	Athens
Greece	General Oncology Hospital Kifissias "Oi Agioi Anargyroi"	Athens
Greece	University General Hospital of Heraklion	Heraklion	Crete
Greece	University General Hospital of Patras	Patras
Greece	Papageorgiou General Hospital	Thessaloniki
Hong Kong	Queen Mary Hospital	Pokfulam	Islands
Hong Kong	Tuen Mun Hospital	Tuen Mun
Hungary	Semmelweis Egyetem	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Petz Aladár Megyei Oktató Kórház	Gyor
Hungary	Bács-Kiskun Megyei Önkormányzat Kórháza	Kecskemét
Hungary	Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház	Miskolc
Hungary	Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelöintézet	Szolnok
Hungary	Veszprém Megyei Önkormányzat Csolnoky Ferenc Kórház-Rendelöintézet	Veszprém
India	Kidwai Memorial Institute of Oncology	Bangalore	Karnataka
India	M.S Ramaiah Medical College and Teaching Hospital Ethical Review Board	Bangalore
India	Jawaharlal Nehru Cancer Hospital & Research Centre	Bhopal	Madhya Pradesh
India	Dr. Kamakshi Memorial Hospital	Chennai	Tamil Nadu
India	Amrita Institute of Medical Sciences and Research Centre	Cochin
India	Apollo Hospitals International Limited	Gandhinagar	Gujarat
India	MNJ Institute of Oncology and Regional Cancer Centre	Hyderabaad
India	Bhagwan Mahaveer Cancer Hospital and Research Centre	Jaipur
India	SK Soni Hospital	Jaipur
India	Lakeshore Hospital	Kochi
India	Chittaranjan National Cancer Institute	Kolkata	West Bengal
India	Tata Memorial Hospital	Mumbai
India	Shatabdi Superspeciality Hospital	Nashik
India	Curie Manavata Cancer Centre	Nasik
India	All India Institute of Medical Sciences	New Delhi
India	Jehangir, Clinical Development Centre	Pune	Maharashtra
India	Ruby Hall Clinic	Pune	Maharashtra
India	Regional Cancer Centre	Trivandrum
Israel	Linn Medical Center, Clalit Health Services	Haifa
Israel	Rambam Medical Center	Haifa
Israel	Wolfson Centre	Holon
Israel	Hadassah University Hospital Ein Kerem	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Meir Medical Center	Kfar Saba
Israel	Rabin Medical Center	Petach Tikva
Israel	The Chaim Sheba Medical Center	Ramat-Gan
Israel	Kaplan Medical Center	Rehovot
Israel	Assaf Harofe Medical Center	Zerifin
Italy	Azienda Ospedaliera Santi Antonio, Biagio e Cesare Arrigo	Alessandria
Italy	Centro di Riferimento Oncologico	Aviano	Pordenone
Italy	Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi	Bologna
Italy	Istituto Ospedaliero Fondazione Poliambulanza	Brescia
Italy	Centro di Ricerca e Formazione ad Alta Tecnologia nelle Scienze Biomediche	Campobasso
Italy	Azienda Ospedaliera Cannizzaro	Catania
Italy	Humanitas Centro Catanese di Oncologia	Catania
Italy	Azienda Ospedaliera Sant'Anna	Como
Italy	Ospedale di Faenza	Faenza
Italy	Azienda Ospedaliera Universitaria San Martino	Genova
Italy	Presidio Ospedaliero Vito Fazzi	Lecce
Italy	Ospedale Mater Salutis ULSS 21 della regione Veneto	Legnago
Italy	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST	Meldola
Italy	Azienda Ospedaliera Niguarda Cà Granda	Milano
Italy	Fondazione Centro San Raffaele del Monte Tabor	Milano
Italy	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico	Milano
Italy	Istituto Nazionale dei Tumori	Milano
Italy	Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Giovanni Pascale"	Napoli
Italy	Ospedale Sacro Cuore Don Calabria	Negrar
Italy	Istituto Oncologico Veneto	Padova
Italy	Ospedale Santa Maria della Misericordia di Perugia	Perugia
Italy	Ospedale Santa Maria delle Croci	Ravenna
Italy	Arcispedale Santa Maria Nuova	Reggio Emilia
Italy	Azienda Policlinico Umberto I	Roma
Italy	Policlinico Universitario "A. Gemelli"	Roma
Italy	Azienda Ospedaliero-Universitaria di Udine	Udine
Korea, Republic of	National Cancer Center	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	In Cheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Cheil General Hospital & Women's Healthcare Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul national univercity hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University College of Medicine	Seoul
Mexico	Union Medica Quirurgica de Colima	Colima
Mexico	Triva Investigaciones Medicas Sociedad Anónima de Capital Variable	Morelia
Mexico	Hospital Regional de Veracruz	Veracruz
Netherlands	VU Medisch Centrum	Amsterdam
Netherlands	Albert Schweitzer Ziekenhuis	Dordrecht
Netherlands	Academisch Ziekenhuis Maastricht	Maastricht
Netherlands	Orbis Medisch Centrum	Sittard-Geleen
Philippines	Cebu Gynecologic Cancer Care Clinic	Cebu
Philippines	Perpetual Succour Hospital	Cebu City	Cebu
Philippines	Manila Doctors Hospital	Manila
Philippines	San Juan de Dios Hospital	Pasay City
Philippines	National Kidney and Transplant Institute	Quezon City
Philippines	St. Luke's Medical Center	Quezon City
Poland	Bialostockie Centrum Onkologii	Bialystok
Poland	Wojewodzkie Centrum Onkologii	Gdansk
Poland	Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie oddzial w Gliwicach	Gliwice
Poland	Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi	Lodz
Poland	Centrum Onkologii Ziemi Lubelskiej	Lublin
Poland	Olsztynski Osrodek Onkologiczny "Kopernik" Sp. z o.o.	Olsztyn
Poland	Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii	Olsztyn
Poland	Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Pozna	Poznan
Poland	Wielkopolskie Centrum Onkologii	Poznan
Poland	SPZOZ Wojewodzki Szpital Specjalistyczny nr 3	Rybnik
Poland	Samodzielny Publiczny Szpital Kliniczny nr 2 PAM w Szczecinie	Szczecin
Poland	Wojskowy Instytut Medyczny	Warszawa
Portugal	Hospitais da Universidade de Coimbra	Coimbra
Portugal	Instituto Português de Oncologia Francisco Gentil, Centro Regional de Oncologia de Coimbra, EPE	Coimbra
Portugal	Instituto Portugues de Oncologia de Lisboa Francisco Gentil (IPOLFG, EPE)	Lisboa
Portugal	Hospital de São João	Porto
Portugal	Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE)	Porto
Russian Federation	Kursk Regional Oncology Centre	Kursk
Russian Federation	Moscow Research Oncology Institute n.a. P.A.Gertsen	Moscow
Russian Federation	Russian Oncology Research Center	Moscow
Russian Federation	Russian Oncology Research Center named after N.N. Blokhin	Moscow
Russian Federation	Medical Radiology Research Center of RAMS	Obninsk
Russian Federation	Ryazan Regional Clinical Oncology Dispensary	Ryazan
Russian Federation	City Clinical Oncology Dispensary	St. Petersburg
Russian Federation	Republican Clinical Oncology Center of Bashkortostan Republic Ministry of Healthcare	Ufa
Singapore	KK Women's and Children's Hospital	Singapore
Singapore	National Cancer Centre	Singapore
Singapore	National University Hospital	Singapore
Spain	Fundacion Hospital Alcorcon	Alcorcón	Madrid, Communidad De
Spain	Hospital Clinic i Provincial	Barcelona	Cataluña
Spain	Hospital Universitario Vall D'Hebron	Barcelona	Cataluna
Spain	Hospital Universitario Reina Sofia	Córdoba	Andalucía
Spain	Hospital General Universitario de Elche	Elche	Comunidad Valenciana
Spain	Hospital 12 de Octubre	Madrid	Madrid, Communidad De
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Marañon	Madrid	Madrid, Communidad De
Spain	Hospital Universitario Ramón y Cajal	Madrid	Madrid, Communidad De
Spain	Hospital de Mataró	Mataró	Cataluña
Spain	Hospital Son Llatzer	Palma de Mallorca	Baleares
Spain	Corporació Sanitaria Parc Taulí	Sabadell	Cataluña
Spain	Hospital Virgen del Rocio	Sevilla	Andalucía
Spain	Hospital Mutua de Terrassa	Terrassa	Cataluña
Spain	Fundación Instituto Valenciano de Oncología	Valencia	Comunidad Valenciana
Switzerland	Universität Zürich	Zürich
Taiwan	National Cheng Kung University Hosptial	Tainan
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital	Taoyuan
Ukraine	Municipal Institution of Cherkasy Regional Counsil "Cherkasy Regional Oncology Dispensary"	Cherkasy
Ukraine	Chernivtsi Regional Clinical Oncology Dispansery	Chernivtsi
Ukraine	Kiev City Oncology Hospital	Kyiv
Ukraine	Volyn Regional Oncology Dispensary	Lutsk
United Kingdom	Belfast City Hospital	Belfast
United Kingdom	Velindre Hospital	Cardiff
United Kingdom	University Hospital Coventry	Coventry
United Kingdom	Ninewells Hospital	Dundee
United Kingdom	Beatson Oncology Centre	Glasgow
United Kingdom	Leicester Royal Infirmary	Leicester
United Kingdom	Hammersmith Hospital	London
United Kingdom	Royal Marsden Hospital	London
United Kingdom	Derriford Hospital	Plymouth
United Kingdom	Poole Hospital NHS Trust	Poole
United Kingdom	Weston Park Hospital	Sheffield
United Kingdom	Clatterbridge Centre For Oncology	Wirral
United Kingdom	New Cross Hospital	Wolverhampton
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	Northern Virginia Pelvic Surgery Associates	Annandale	Virginia
United States	Medical College of Georgia	Augusta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	Texas Oncology, PA	Austin	Texas
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	John Hopkins University	Baltimore	Maryland
United States	Mercy Medical Center	Baltimore	Maryland
United States	Weinberg Cancer Institute at Franklin Square	Baltimore	Maryland
United States	Texas Oncology, P.A.	Bedford	Texas
United States	Center for Cancer and Blood Disorders	Bethesda	Maryland
United States	St. Luke's Hospital	Bethlehem	Pennsylvania
United States	University Of Alabama At Birmingham	Birmingham	Alabama
United States	Palm Beach Institute of Hematology and Oncology	Boynton Beach	Florida
United States	University Cancer Institute	Boynton Beach	Florida
United States	Harrison Bremerton Hematology and Oncology	Bremerton	Washington
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Providence St. Joseph Medical Center	Burbank	California
United States	The Center for Cancer and Hematologic Disease	Camden	New Jersey
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Presbyterian Hospital	Charlotte	North Carolina
United States	Chattanooga's Program in Women's Oncology	Chattanooga	Tennessee
United States	Catholic Health Initiatives	Cincinnati	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Catholic Health Initiatives	Colorado Springs	Colorado
United States	Baylor Sammons Cancer Center	Dallas	Texas
United States	Texas Oncology, PA	Dallas	Texas
United States	Miami Valley Hospital	Dayton	Ohio
United States	Denver Health and Hospital Authority	Denver	Colorado
United States	Hematology-Oncolgy Associates of NNJ-PA	Denville	New Jersey
United States	Barbara Ann Kamanos Cancer Center	Detroit	Michigan
United States	Henry Ford Health System	Detroit	Michigan
United States	Oncology Hematology Associates	DuBois	Pennsylvania
United States	Duke University Medical Center	Durham	North Carolina
United States	Providence Everett Medical Center	Everett	Washington
United States	Frederick Memorial Hospital	Frederick	Maryland
United States	Gainsville Hematology Oncology Associates	Gainesville	Florida
United States	Medical & Surgical Specialists, LLC	Galesburg	Illinois
United States	Gettysburg Cancer Center	Gettysburg	Pennsylvania
United States	Saint Francis Memorial Health Center	Grand Island	Nebraska
United States	Saint Mary's Health Care	Grand Rapids	Michigan
United States	California Cancer Care, Inc.	Greenbrae	California
United States	John Theurer Cancer Center at Hackensack University MC	Hackensack	New Jersey
United States	International Beneficence Clinical Research, L.L.C.	Harlingen	Texas
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Kaiser Permanente - Moanalua Medical Center	Honolulu	Hawaii
United States	Kapi'olani Medical Center for Women and Children	Honolulu	Hawaii
United States	University of Texas Health Science Center at Houston Medical School	Houston	Texas
United States	Oncology Specialties, PC	Huntsville	Alabama
United States	St. Francis Hospital & Health Centers	Indianapolis	Indiana
United States	St. Vincent Gynecologic Oncology	Indianapolis	Indiana
United States	Baptist Cancer Institute	Jacksonville	Florida
United States	Jupiter Medical center Physician's Group	Jupiter	Florida
United States	Good Samaritan Hospital Cancer Center	Kearney	Nebraska
United States	Kettering Medical Center	Kettering	Ohio
United States	University of California San Diego	La Jolla	California
United States	Arena Oncology Associates	Lake Success	New York
United States	Hematology/Oncology Associates	Lake Worth	Florida
United States	Lakeland Regional Cancer Center	Lakeland	Florida
United States	Sparrow Regional Cancer Center	Lansing	Michigan
United States	Central Baptist Hospital	Lexington	Kentucky
United States	University of California Los Angeles Medical Center	Los Angeles	California
United States	Norton Healthcare	Louisville	Kentucky
United States	University of Louisville	Louisville	Kentucky
United States	Loyola University Chicago	Maywood	Illinois
United States	Hematology & Oncology Specialists	Metairie	Louisiana
United States	Signal Point Clinical Research Center, LLC	Middletown	Ohio
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	Gynecologic Oncology Associates	Newport Beach	California
United States	Peninsula Cancer Institute - Riverside Gynecology Oncology	Newport News	Virginia
United States	Northern Utah Associates	Ogden	Utah
United States	Florida Hospital	Orlando	Florida
United States	Arizona Hematology & Oncology Associates	Phoenix	Arizona
United States	St. Joseph's Hospital, Barrow Neurology Clinics	Phoenix	Arizona
United States	Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania
United States	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Kaiser Permanente Northwest	Portland	Oregon
United States	Oregon Health & Science University	Portland	Oregon
United States	Providence Oncology & Hematology Care	Portland	Oregon
United States	University of California Davis Cancer Center	Sacramento	California
United States	Park Nicollet Institute	Saint Louis Park	Minnesota
United States	Gulfcoast Oncology	Saint Petersburg	Florida
United States	Utah Cancer Specialists	Salt Lake City	Utah
United States	South Texas Oncology and Hematology, PA	San Antonio	Texas
United States	Sarasota Memorial Healthcare System	Sarasota	Florida
United States	Memorial Health University Medical Center	Savannah	Georgia
United States	Midwest Cancer Research Group	Skokie	Illinois
United States	Cancer Care Northwest-South	Spokane	Washington
United States	Willamette Valley Cancer Center	Springfield	Oregon
United States	Hematology Oncology P.C.	Stamford	Connecticut
United States	Stanford University	Stanford	California
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Oncology-Hematology Associates of W. Broward P.A.	Tamarac	Florida
United States	Scott and White Memorial Hospital	Temple	Texas
United States	Arizona Cancer Center	Tucson	Arizona
United States	Arizona Oncology Associates	Tucson	Arizona
United States	Cancer Care Associates	Tulsa	Oklahoma
United States	Northwest Cancer Specialists, PC	Vancouver	Washington
United States	Cooper Cancer Institute	Voorhees	New Jersey
United States	Washington Hospital Center	Washington	District of Columbia
United States	Aurora Health Care	West Allis	Wisconsin
United States	Palm Beach Cancer Institute	West Palm Beach	Florida
United States	US Oncology Research	Wichita Falls	Texas
United States	Central DuPage Hospital	Winfield	Illinois
United States	Piedmont Hematology & Oncology	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Morphotek	Eisai Europe Ltd. (United Kingdom)

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  France,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Philippines,  Poland,  Portugal,  Russian Federation,  Singapore,  Spain,  Switzerland,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	CL: Clearance of Total Carboplatin and Total Paclitaxel		Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)
Secondary	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)
Secondary	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)