Efficacy and Safety of MORAb-003 in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Morphotek
ClinicalTrials.gov Identifier:
NCT00849667
First received: February 13, 2009
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Drug: MORAb-003 (farletuzumab)
Drug: 0.9% Saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly MORAb-003 in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse

Resource links provided by NLM:


Further study details as provided by Morphotek:

Primary Outcome Measures:
  • Progression-free survival using by RECIST [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival, CA-125 PFS, GCIG PFS, Length of first versus second remission, Tumor Response,Serologic Response (CA-125), Quality of Life, Resource utilization and PK DDI substudy. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 1100
Study Start Date: April 2009
Study Completion Date: April 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Carboplatin and taxane with MORAb-003 1.25 mg/kg
Drug: MORAb-003 (farletuzumab)
MORAb-003 1.25 mg/kg infusions will take place weekly during combination therapy and then as single agent maintenance until progression.
Active Comparator: 2
Carboplatin and taxane with MORAb-003 2.5 mg/kg
Drug: MORAb-003 (farletuzumab)
MORAb-003 2.5mg/kg infusions will take place weekly during combination therapy and then as single agent maintenance until progression.
Placebo Comparator: 3
Carboplatin and taxane with Placebo
Drug: 0.9% Saline
0.9% infusions will take place weekly during combination therapy and then as single agent maintenance until progression.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00849667

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

No publications provided

Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT00849667     History of Changes
Other Study ID Numbers: MORAb003-004
Study First Received: February 13, 2009
Last Updated: November 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Morphotek:
ovarian cancer
relapsed ovarian cancer
Platinum-sensitive Ovarian Cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014