Study Stopped
Lack of efficacy
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
2 other identifiers
interventional
1,100
29 countries
369
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 ovarian-cancer
Started Apr 2009
369 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2009
CompletedFirst Posted
Study publicly available on registry
February 24, 2009
CompletedStudy Start
First participant enrolled
April 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2013
CompletedResults Posted
Study results publicly available
December 30, 2022
CompletedDecember 30, 2022
November 1, 2022
3.7 years
February 13, 2009
December 5, 2022
December 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (18)
Overall Survival (OS)
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
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
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
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
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)
- +13 more secondary outcomes
Study Arms (3)
Farletuzumab (1.25 mg/kg)
ACTIVE COMPARATORParticipants 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.
Farletuzumab (2.5 mg/kg)
ACTIVE COMPARATORParticipants 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.
Placebo
PLACEBO COMPARATORParticipants 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.
Interventions
Farletuzumab IV infusion.
Taxane (Paclitaxel or Docetaxel) IV infusion.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Morphoteklead
- Eisai Europe Ltd. (United Kingdom)collaborator
Study Sites (375)
University Of Alabama At Birmingham
Birmingham, Alabama, 35233, United States
Oncology Specialties, PC
Huntsville, Alabama, 35801, United States
Arizona Hematology & Oncology Associates
Phoenix, Arizona, 85012, United States
St. Joseph's Hospital, Barrow Neurology Clinics
Phoenix, Arizona, 85013, United States
Arizona Oncology Associates
Tucson, Arizona, 85712, United States
Arizona Cancer Center
Tucson, Arizona, 85724, United States
Providence St. Joseph Medical Center
Burbank, California, 91505, United States
California Cancer Care, Inc.
Greenbrae, California, 94904, United States
University of California San Diego
La Jolla, California, 92093-0698, United States
University of California Los Angeles Medical Center
Los Angeles, California, 90095, United States
Gynecologic Oncology Associates
Newport Beach, California, 92663, United States
University of California Davis Cancer Center
Sacramento, California, 95817, United States
Stanford University
Stanford, California, 94305, United States
University of Colorado
Aurora, Colorado, 80045, United States
Catholic Health Initiatives
Colorado Springs, Colorado, 80907, United States
Denver Health and Hospital Authority
Denver, Colorado, 80204, United States
Hematology Oncology P.C.
Stamford, Connecticut, 06902, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Palm Beach Institute of Hematology and Oncology
Boynton Beach, Florida, 33435, United States
University Cancer Institute
Boynton Beach, Florida, 33435, United States
Gainsville Hematology Oncology Associates
Gainesville, Florida, 32605, United States
Baptist Cancer Institute
Jacksonville, Florida, 32207, United States
Jupiter Medical center Physician's Group
Jupiter, Florida, 33458, United States
Hematology/Oncology Associates
Lake Worth, Florida, 33461, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33805, United States
Florida Hospital
Orlando, Florida, 32804, United States
Sarasota Memorial Healthcare System
Sarasota, Florida, 34239, United States
Gulfcoast Oncology
St. Petersburg, Florida, 33705, United States
Oncology-Hematology Associates of W. Broward P.A.
Tamarac, Florida, 33321, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
Kaiser Permanente - Moanalua Medical Center
Honolulu, Hawaii, 96819, United States
Kapi'olani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Medical & Surgical Specialists, LLC
Galesburg, Illinois, 61401, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60425, United States
Loyola University Chicago
Maywood, Illinois, 60153, United States
Midwest Cancer Research Group
Skokie, Illinois, 60625, United States
Central DuPage Hospital
Winfield, Illinois, 60190, United States
St. Francis Hospital & Health Centers
Indianapolis, Indiana, 46237, United States
St. Vincent Gynecologic Oncology
Indianapolis, Indiana, 46260, United States
Central Baptist Hospital
Lexington, Kentucky, 40503, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Norton Healthcare
Louisville, Kentucky, 40207, United States
Hematology & Oncology Specialists
Metairie, Louisiana, 70006, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
John Hopkins University
Baltimore, Maryland, 21231, United States
Weinberg Cancer Institute at Franklin Square
Baltimore, Maryland, 21237-3998, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
Frederick Memorial Hospital
Frederick, Maryland, 21701, United States
Barbara Ann Kamanos Cancer Center
Detroit, Michigan, 48201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Saint Mary's Health Care
Grand Rapids, Michigan, 49503, United States
Sparrow Regional Cancer Center
Lansing, Michigan, 48909, United States
Park Nicollet Institute
Saint Louis Park, Minnesota, 55426, United States
Saint Francis Memorial Health Center
Grand Island, Nebraska, 68803, United States
Good Samaritan Hospital Cancer Center
Kearney, Nebraska, 68847, United States
The Center for Cancer and Hematologic Disease
Camden, New Jersey, 08003, United States
Hematology-Oncolgy Associates of NNJ-PA
Denville, New Jersey, 07834, United States
John Theurer Cancer Center at Hackensack University MC
Hackensack, New Jersey, 07601, United States
Morristown Memorial Hospital
Morristown, New Jersey, 07962, United States
Cooper Cancer Institute
Voorhees Township, New Jersey, 08043, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Arena Oncology Associates
Lake Success, New York, 11042, United States
Columbia University Medical Center
New York, New York, 10032, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Carolinas Medical Center
Charlotte, North Carolina, 28204, United States
Presbyterian Hospital
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Piedmont Hematology & Oncology
Winston-Salem, North Carolina, 27103, United States
Catholic Health Initiatives
Cincinnati, Ohio, 45220, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44195, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Signal Point Clinical Research Center, LLC
Middletown, Ohio, 45042, United States
Cancer Care Associates
Tulsa, Oklahoma, 74136, United States
Providence Oncology & Hematology Care
Portland, Oregon, 95213, United States
Kaiser Permanente Northwest
Portland, Oregon, 97227, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Willamette Valley Cancer Center
Springfield, Oregon, 97477, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
St. Luke's Hospital
Bethlehem, Pennsylvania, 18015, United States
Oncology Hematology Associates
DuBois, Pennsylvania, 15801, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325, United States
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Chattanooga's Program in Women's Oncology
Chattanooga, Tennessee, 37403, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Texas Oncology, PA
Austin, Texas, 78705, United States
Texas Oncology, P.A.
Bedford, Texas, 76022, United States
Texas Oncology, PA
Dallas, Texas, 75231, United States
Baylor Sammons Cancer Center
Dallas, Texas, 75246, United States
International Beneficence Clinical Research, L.L.C.
Harlingen, Texas, 78550, United States
University of Texas Health Science Center at Houston Medical School
Houston, Texas, 77030, United States
South Texas Oncology and Hematology, PA
San Antonio, Texas, 78229, United States
Scott and White Memorial Hospital
Temple, Texas, 76508, United States
US Oncology Research
Wichita Falls, Texas, 76310, United States
Northern Utah Associates
Ogden, Utah, 84403, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Northern Virginia Pelvic Surgery Associates
Annandale, Virginia, 22003, United States
Peninsula Cancer Institute - Riverside Gynecology Oncology
Newport News, Virginia, 23601, United States
Harrison Bremerton Hematology and Oncology
Bremerton, Washington, 98310, United States
Providence Everett Medical Center
Everett, Washington, 98201, United States
Cancer Care Northwest-South
Spokane, Washington, 99202, United States
Northwest Cancer Specialists, PC
Vancouver, Washington, 98684, United States
Aurora Health Care
West Allis, Wisconsin, 53227, United States
Hospital Zonal Especializado en Oncología de Lanús
Buenos Aires, 1824, Argentina
Consultorios Medicos Privados SA
Buenos Aries, 1704, Argentina
Fundación Sanatorio Güemes
CABA, 1180, Argentina
Clinica Universitaria Reina Fabiola
Códoba, 5004, Argentina
Instituto Medico Platense
La Plata, 1900, Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja, F5300COE, Argentina
Hospital Bocalandro
Loma Hermosa, 1657, Argentina
Centro Oncologico Integral
Mar del Plata, B7600LTO, Argentina
CER Instituto Medico
Quilmes, B1878DVB, Argentina
Centro Médico San Roque
San Miguel de Tucumán, 4000, Argentina
Centro Medico de Alta Complejidad Cemac
San Salvador de Jujuy, 4600, Argentina
ISIS Centro Especializado de LUCE SA
Santa Fe, S3000FFU, Argentina
Tweed Hospital
Tweed Heads, New South Wales, 2485, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
The Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Mater Adult Hospital
South Brisbane, Queensland, 4101, Australia
North Adelaide Oncology Clinical Trials
North Adelaide, South Australia, 5006, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Kaiser-Franz-Josef Spital
Vienna, 1100, Austria
Krankenhaus Wien-Hietzing
Vienna, 1130, Austria
Landeskrankenhaus Villach
Villach, 9500, Austria
Institut Jules Bordet
Brussels, 1000, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
UZ Gent
Ghent, 9000, Belgium
AZ Groeninge - Campus Maria's Voorzienigheid
Kortrijk, 8500, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHU de Liège
Liège, 4000, Belgium
Sint-Augustinuskliniek
Wilrijk, 2610, Belgium
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, 14784-400, Brazil
Instituto de Pesquisas Clínicas para Estudos Multicêntricos
Caxias do Sul, 95070-560, Brazil
Santa Casa da Misericórdia de Curitiba
Curitiba, 80010-030, Brazil
Instituto do Câncer do Ceará - ICC
Fortaleza, 60430-230, Brazil
Hosp. Araujo Jorge
Goiânia, 74605-160, Brazil
Associação Hospital de Caridade Ijuí
Ijuí, 98700-000, Brazil
Clinica de Neoplasias Litoral
Itajaí, 88301-220, Brazil
Hospital Amaral Carvalho
Jaú, 17210-120, Brazil
Liga Norte-Riograndense Contra o Câncer
Natal, 59062-000, Brazil
Irmandade Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, 90050-170, Brazil
Clínica de Oncologia de Porto Alegre S/S Ltda
Porto Alegre, 90430-090, Brazil
Instituto Ribeirãopretano de Combate ao Câncer
Ribeirão Preto, 14015-130, Brazil
Clínica Oncologistas Associados
Rio de Janeiro, 22260-020, Brazil
INCA - Instituto Nacional do Câncer
Rio de Janeiro - RJ, 20220-410, Brazil
Hospital Santa Izabel - Santa Casa de Misericordia da Bahia
Salvador, 40050-410, Brazil
Clínica AMO - Assistência Multidiciplinar em Oncologia
Salvador, 41825-010, Brazil
Centro de Estudos de Oncologia da FMABC
Santo André, 09060-650, Brazil
Saúde ABC Serviços Médicos Hospitalares Ltda
Santo André, 09090-780, Brazil
Instituto do Câncer Arnaldo Vieira de Carvalho
São Paulo, 01209-000, Brazil
Certo Oncologia
São Paulo, 04551-010, Brazil
Hospital Premier
São Paulo, 04583-100, Brazil
Tom Baker Cancer Centre
Calgary, Alberta, T2N-4N2, Canada
Cancer Center For The Southern Interior
Kelowna, British Columbia, V1Y5L3, Canada
British Columbia Cancer Agency
Surrey, British Columbia, V3V 1Z2, Canada
BCCA
Vancouver, British Columbia, V5Z 4E6, Canada
The Moncton Hospital
Moncton, New Brunswick, E1C6Z8, Canada
Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Instituto de Terapias Oncologicas
Santiago, 7501088, Chile
Instituto Clínico Oncológico del Sur
Temuco, 4810469, Chile
Instituto Oncologico Ltda.
Viña del Mar, Chile
Centre Régional de lutte contre le cancer Paul Papin
Angers, 49933, France
Centre Hospitalier Louis Pasteur
Le Coudray, 28630, France
Institut Paoli Calmettes
Marseille, 13273, France
Hôpital Saint Louis
Paris, 75475, France
Institut Jean Godinot - Centre de lutte contre le cancer
Reims, 51056, France
Charité - Universitätsmedizin Berlin
Berlin, 13353, Germany
Helios Klinikum Berlin-Buch
Buch, 13125, Germany
Klinikum Chemnitz gGmbH
Chemnitz, 09116, Germany
Marien-Hospital Akademisches Lehrkrankenhaus
Düsseldorf, 40479, Germany
Frauenarztpraxis Dr. med. Gröll de Rivera
Ebersberg, 85560, Germany
Universitätsklinikum Essen
Essen, 45122, Germany
Krankenhaus Nordwest
Frankfurt, 60488, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Kath. Marienkrankenhaus gGmbH
Hamburg, 22087, Germany
Universität Heidelberg
Heidelberg, 69120, Germany
St. Vincentius Kliniken Karlsruhe
Karlsruhe, 76135, Germany
Universitätsklinik Magdeburg
Magdeburg, 39108, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131, Germany
Klinikum der Universität München - Innenstadt
München, 80337, Germany
Rotkreuzklinikum München
München, 80637, Germany
Klinikum Südstadt Rostock
Rostock, 18059, Germany
Klinikum Traunstein
Traunstein, 83278, Germany
University General Hospital of Heraklion
Heraklion, Crete, 71110, Greece
Alexandra Hospital
Athens, 115 28, Greece
General Oncology Hospital Kifissias "Oi Agioi Anargyroi"
Athens, 145 64, Greece
University General Hospital of Patras
Pátrai, 26500, Greece
Papageorgiou General Hospital
Thessaloniki, 564 29, Greece
Queen Mary Hospital
Pokfulam, Islands District, Hong Kong
Tuen Mun Hospital
Tuenmen, Hong Kong
Semmelweis Egyetem
Budapest, 1082, Hungary
Semmelweis Egyetem
Budapest, 1088, Hungary
Petz Aladár Megyei Oktató Kórház
Győr, 9024, Hungary
Bács-Kiskun Megyei Önkormányzat Kórháza
Kecskemét, 6000, Hungary
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
Miskolc, 3526, Hungary
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelöintézet
Szolnok, 5004, Hungary
Veszprém Megyei Önkormányzat Csolnoky Ferenc Kórház-Rendelöintézet
Veszprém, 8200, Hungary
Apollo Hospitals International Limited
Gandhinagar, Gujarat, 382428, India
Kidwai Memorial Institute of Oncology
Bangalore, Karnataka, 560032, India
Jawaharlal Nehru Cancer Hospital & Research Centre
Bhopal, Madhya Pradesh, 462001, India
Jehangir, Clinical Development Centre
Pune, Maharashtra, 411001, India
Ruby Hall Clinic
Pune, Maharashtra, 411001, India
Dr. Kamakshi Memorial Hospital
Chennai, Tamil Nadu, 600100, India
Chittaranjan National Cancer Institute
Kolkata, West Bengal, 700026, India
M.S Ramaiah Medical College and Teaching Hospital Ethical Review Board
Bangalore, 560054, India
MNJ Institute of Oncology and Regional Cancer Centre
Hyderabaad, 500004, India
SK Soni Hospital
Jaipur, 302013, India
Bhagwan Mahaveer Cancer Hospital and Research Centre
Jaipur, 302017, India
Amrita Institute of Medical Sciences and Research Centre
Kochi, 682026, India
Lakeshore Hospital
Kochi, 682304, India
Tata Memorial Hospital
Mumbai, 400012, India
Curie Manavata Cancer Centre
Nashik, 422004, India
Shatabdi Superspeciality Hospital
Nashik, 422005, India
All India Institute of Medical Sciences
New Delhi, 110029, India
Regional Cancer Centre
Trivandrum, 695011, India
Rambam Medical Center
Haifa, 31096, Israel
Linn Medical Center, Clalit Health Services
Haifa, 35152, Israel
Wolfson Centre
Holon, 58100, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Hadassah University Hospital Ein Kerem
Jerusalem, 91120, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
The Chaim Sheba Medical Center
Ramat Gan, 52621, Israel
Kaplan Medical Center
Rehovot, 76100, Israel
Assaf Harofe Medical Center
Ẕerifin, 70300, Israel
Centro di Riferimento Oncologico
Aviano, Pordenone, 33081, Italy
Azienda Ospedaliera Santi Antonio, Biagio e Cesare Arrigo
Alessandria, 15100, Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna, 40138, Italy
Istituto Ospedaliero Fondazione Poliambulanza
Brescia, 25124, Italy
Centro di Ricerca e Formazione ad Alta Tecnologia nelle Scienze Biomediche
Campobasso, 86100, Italy
Azienda Ospedaliera Cannizzaro
Catania, 95126, Italy
Humanitas Centro Catanese di Oncologia
Catania, 95126, Italy
Azienda Ospedaliera Sant'Anna
Como, 22100, Italy
Ospedale di Faenza
Faenza, 48018, Italy
Azienda Ospedaliera Universitaria San Martino
Genova, 16132, Italy
Presidio Ospedaliero Vito Fazzi
Lecce, 73044, Italy
Ospedale Mater Salutis ULSS 21 della regione Veneto
Legnago, 37045, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST
Meldola, 47014, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Fondazione Centro San Raffaele del Monte Tabor
Milan, 20132, Italy
Istituto Nazionale dei Tumori
Milan, 20133, Italy
Azienda Ospedaliera Niguarda Cà Granda
Milan, 20162, Italy
Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Giovanni Pascale"
Napoli, 80131, Italy
Ospedale Sacro Cuore Don Calabria
Negrar, 37024, Italy
Istituto Oncologico Veneto
Padua, 35128, Italy
Ospedale Santa Maria della Misericordia di Perugia
Perugia, 06132, Italy
Ospedale Santa Maria delle Croci
Ravenna, 48100, Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, 42100, Italy
Azienda Policlinico Umberto I
Roma, 00161, Italy
Policlinico Universitario "A. Gemelli"
Roma, 00168, Italy
Azienda Ospedaliero-Universitaria di Udine
Udine, 33100, Italy
Unknown Facility
Akashi, Japan
Unknown Facility
Amagasaki, Japan
Unknown Facility
Chiba, Japan
Unknown Facility
Fukuoka, Japan
Unknown Facility
Hidaka, Japan
Unknown Facility
Hiroshima, Japan
Unknown Facility
Kagoshima, Japan
Unknown Facility
Kashiwa, Japan
Unknown Facility
Kawasaki, Japan
Unknown Facility
Kōtoku, Japan
Unknown Facility
Kumamoto, Japan
Unknown Facility
Kure, Japan
Unknown Facility
Kurume, Japan
Unknown Facility
Matsuyama, Japan
Unknown Facility
Minatoku, Japan
Unknown Facility
Morioka, Japan
Unknown Facility
Nagoya, Japan
Unknown Facility
Nakano, Japan
Unknown Facility
Niigata, Japan
Unknown Facility
Okayama, Japan
Unknown Facility
Osaka, Japan
Unknown Facility
Sapporo, Japan
Unknown Facility
Sayama, Japan
Unknown Facility
Sendai, Japan
Unknown Facility
Shinjuku-Ku, Japan
Unknown Facility
Sunto-Gun, Japan
Unknown Facility
Tsu, Japan
Unknown Facility
Tsukuba, Japan
Unknown Facility
Yamagata, Japan
Unknown Facility
Yonago, Japan
Union Medica Quirurgica de Colima
Colima, 3402, Mexico
Triva Investigaciones Medicas Sociedad Anónima de Capital Variable
Morelia, 58000, Mexico
Hospital Regional de Veracruz
Veracruz, 91700, Mexico
VU Medisch Centrum
Amsterdam, 1081 HV, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, 3318 AT, Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, 6229 HX, Netherlands
Orbis Medisch Centrum
Sittard-Geleen, 6162 BG, Netherlands
Perpetual Succour Hospital
Cebu City, Cebu, 6000, Philippines
Cebu Gynecologic Cancer Care Clinic
Cebu, 6000, Philippines
Manila Doctors Hospital
Manila, 1000, Philippines
San Juan de Dios Hospital
Pasay, 1300, Philippines
St. Luke's Medical Center
Quezon City, 1102, Philippines
National Kidney and Transplant Institute
Quezon City, 1112, Philippines
Bialostockie Centrum Onkologii
Bialystok, 15-027, Poland
Wojewodzkie Centrum Onkologii
Gdansk, 80-219, Poland
Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie oddzial w Gliwicach
Gliwice, 44-100, Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz, 93-509, Poland
Centrum Onkologii Ziemi Lubelskiej
Lublin, 20-090, Poland
Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii
Olsztyn, 10-228, Poland
Olsztynski Osrodek Onkologiczny "Kopernik" Sp. z o.o.
Olsztyn, 10-513, Poland
Wielkopolskie Centrum Onkologii
Poznan, 61-866, Poland
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Pozna
Poznan, 61-878, Poland
SPZOZ Wojewodzki Szpital Specjalistyczny nr 3
Rybnik, 44-200, Poland
Samodzielny Publiczny Szpital Kliniczny nr 2 PAM w Szczecinie
Szczecin, 70-111, Poland
Wojskowy Instytut Medyczny
Warsaw, 04-141, Poland
Hospitais da Universidade de Coimbra
Coimbra, 3000-075, Portugal
Instituto Português de Oncologia Francisco Gentil, Centro Regional de Oncologia de Coimbra, EPE
Coimbra, 3000-075, Portugal
Instituto Portugues de Oncologia de Lisboa Francisco Gentil (IPOLFG, EPE)
Lisbon, 1099-023, Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE)
Porto, 4200-072, Portugal
Hospital de São João
Porto, 4200-319, Portugal
Kursk Regional Oncology Centre
Kursk, 305035, Russia
Russian Oncology Research Center named after N.N. Blokhin
Moscow, 115478, Russia
Russian Oncology Research Center
Moscow, 115478, Russia
Moscow Research Oncology Institute n.a. P.A.Gertsen
Moscow, 125284, Russia
Medical Radiology Research Center of RAMS
Obninsk, 249036, Russia
Ryazan Regional Clinical Oncology Dispensary
Ryazan, 390011, Russia
City Clinical Oncology Dispensary
Saint Petersburg, 198255, Russia
Republican Clinical Oncology Center of Bashkortostan Republic Ministry of Healthcare
Ufa, 450054, Russia
National University Hospital
Singapore, 119074, Singapore
National Cancer Centre
Singapore, 169610, Singapore
KK Women's and Children's Hospital
Singapore, 229899, Singapore
National Cancer Center
Gyeonggi-do, 410-769, South Korea
Gachon University Gil Medical Center
Incheon, 405760, South Korea
Cheil General Hospital & Women's Healthcare Center
Seoul, 100380, South Korea
Seoul national univercity hospital
Seoul, 110-744, South Korea
Severance Hospital, Yonsei University College of Medicine
Seoul, 120752, South Korea
Samsung Medical Center
Seoul, 135710, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Hospital Universitario Reina Sofia
Córdoba, Andalusia, 14004, Spain
Hospital Virgen del Rocio
Seville, Andalusia, 41013, Spain
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, 07198, Spain
Hospital Universitario Vall D'Hebron
Barcelona, Catalonia, 08035, Spain
Hospital Clinic i Provincial
Barcelona, Catalonia, 08036, Spain
Hospital de Mataró
Mataró, Catalonia, 08034, Spain
Corporació Sanitaria Parc Taulí
Sabadell, Catalonia, 08208, Spain
Hospital Mutua de Terrassa
Terrassa, Catalonia, 08221, Spain
Fundacion Hospital Alcorcon
Alcorcón, Madrid, Communidad de, 28922, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Communidad de, 28007, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Communidad de, 28034, Spain
Hospital 12 de Octubre
Madrid, Madrid, Communidad de, 28041, Spain
Hospital General Universitario de Elche
Elche, Valencia, 03203, Spain
Fundación Instituto Valenciano de Oncología
Valencia, Valencia, 46009, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Universität Zürich
Zurich, 8091, Switzerland
National Cheng Kung University Hosptial
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Mackay Memorial Hospital
Taipei, 104, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Tri-Service General Hospital
Taipei, 114, Taiwan
Chang Gung Memorial Hospital
Taoyuan District, 333, Taiwan
Municipal Institution of Cherkasy Regional Counsil "Cherkasy Regional Oncology Dispensary"
Cherkasy, 18009, Ukraine
Chernivtsi Regional Clinical Oncology Dispansery
Chernivtsi, 58013, Ukraine
Kiev City Oncology Hospital
Kyiv, 03115, Ukraine
Volyn Regional Oncology Dispensary
Lutsk, 43018, Ukraine
Belfast City Hospital
Belfast, BT9 7AB, United Kingdom
Velindre Hospital
Cardiff, CF14 2TL, United Kingdom
University Hospital Coventry
Coventry, CV2 2DX, United Kingdom
Ninewells Hospital
Dundee, DD1 9SY, United Kingdom
Beatson Oncology Centre
Glasgow, G12 0YN, United Kingdom
Leicester Royal Infirmary
Leicester, LE1 5WW, United Kingdom
Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Hammersmith Hospital
London, W12 0HS, United Kingdom
Clatterbridge Centre For Oncology
Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
Poole Hospital NHS Trust
Poole, BH15 2JB, United Kingdom
Weston Park Hospital
Sheffield, S10 2SJ, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study termination was based on the primary analysis results for progression-free survival (PFS). Data collection and analyses of health care resource utilization were not performed due to the study being terminated early. Pharmacokinetic data was collected and analyzed for a maximum of only 7 participants in this study.
Results Point of Contact
- Title
- Eisai Medical Information
- Organization
- Eisai Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2009
First Posted
February 24, 2009
Study Start
April 16, 2009
Primary Completion
December 31, 2012
Study Completion
April 12, 2013
Last Updated
December 30, 2022
Results First Posted
December 30, 2022
Record last verified: 2022-11