130
Participants
Start Date
June 27, 2011
Primary Completion Date
December 15, 2012
Study Completion Date
November 1, 2013
Farletuzumab
"Combination Therapy: Farletuzumab 7.5 mg/kg will be administered intravenously on Cycle 1, Week 1 and Cycle 1, Week 2 (loading dose). Beginning on Cycle 2, Week 1, farletuzumab (7.5 mg/kg) will be administered intravenously on Week 1 of all additional cycles.~Monotherapy: Farletuzumab 7.5 mg/kg will be administered intravenously on Week 1 of every 3-week cycle until disease progression."
Placebo
"Combination Therapy: Placebo will be administered intravenously on Cycle 1, Week 1 and Cycle 1, Week 2 (loading dose). Beginning on Cycle 2, Week 1, placebo will be administered IV on Week 1 of all additional cycles.~Monotherapy: Placebo will be administered intravenously on Week 1 of every 3-week cycle until disease progression."
Carboplatin
Carboplatin will be administered intravenously to achieve area under the serum concentration-time curve of 5 to 6 mg/mL\^min \[AUC5-6\].
Paclitaxel
Paclitaxel 200 mg/m\^2 will be administered intravenously.
Pemetrexed
Pemetrexed 500 mg/m\^2 will be administered intravenously.
Cisplatin
Cisplatin 75 mg/m\^2 will be administered intravenously.
The Tweed Hospital, Tweed Heads
Southern Medical Day Oncology Care Centre, Wollongong
Epworth Healthcare, Richmond
Box Hill Hospital, Box Hill
Frankston Hospital, Oncology Day Unit, Frankston
Royal Brisbane and Women's Hospital, Dept. of Medical Oncology, Brisbane
Princess Alexandra Hospital, Woolloongabba
Royal Adelaide Hospital, Cancer Centre, Adelaide
The Queen Elizabeth Hospital, Woodville South
Flinders Medical Centre, Dept. of Oncology, Bedford Park
Lyell McEwin Hospital, Elizabeth Vale
Fremantle Hospital, Fremantle
"Azienda Ospedaliero-Univesitaria San Luigi Gonzaga", Orbassano
Queens Hospital Center, Jamaica
Syracuse Veterns Affairs Medical Center, Syracuse
HELIOS Klinikum Emil von Behring, Berlin
Istituto Nazionale per la Ricerca sul Cancro, Genova
Gettysburg Cancer Center, Gettysburg
St. Luke's Cancer Center Associates, Bethlehem
National Cancer Institute, Bethesda
Maryland Oncology Hematology, P.A., Columbia
Asklepios Klinik Harburg, Hamburg
Virginia Cancer Specialists, PC, Fairfax
Delta Hematology Oncology Associates, PC, Portsmouth
Fundación Jiménez Díaz, Madrid
Hospital Regional Carlos Haya, Málaga
Cancer Care of North Florida, Lake City
Johannes-Wesling-Klinikum Minden, Minden
MD Anderson Cancer Center-Orlando, Orlando
Broward General Medical Center, Fort Lauderdale
Medical Specialists of the Palm Beaches, Deerfield Beach
Center for Hematology-Oncology, Boca Raton
Ocala Oncology Center, PL, Ocala
Florida Cancer Institute-New Hope, New Port Richey
Tennessee Oncology, PLLC, Nashville
Baptist Health System, Inc., Lexington
Kentucky Cancer Center, Hazard
The Community Hospital, Munster
Deaconess Clinic Downtown, Evansville
Detroit Clinical Research Center, Farmington Hills
Cancer Team Bellin Health, Green Bay
Ospedale Unico Versilia, Lido di Camaiore
Krankenhaus Nordwest GmbH, Frankfurt am Main
University of Chicago Medical Center, Chicago
University Hematology Oncology, Inc., Centralia
Universitätsklinikum Heidelberg, Heidelberg
Hematology and Oncology Specialists, LLC, Metairie
Christus Saint Frances, Cabrini Hospital, Cabrini Cancer Center, Alexandria
Klinik Löwenstein gGmbH, Löwenstein
Texas Oncology - Bedford, Bedford
Texas Oncology - Waco, Waco
Houston Cancer Institute, Houston
Northwest Cancer Center, Sugar Land
University of Texas Medical Branch, Galveston
A.O. Seconda Università degli Studi di Napoli, Napoli
Asklepios Fachkliniken München-Gauting, Gauting
Ironwood Cancer and Research Center, Chandler
Glendale Adventist Medical Center, Los Angeles
Clinical Trials and Research Associates, Inc., Montebello
Wilshire Medical Oncology Group, La Verne
North Country Oncology-Hematology, Oceanside
Moores University of California San Diego Cancer Center, La Jolla
Central Coast Medical Oncology, Santa Maria
Cancer Care Associates of Fresno Medical Group, Inc., Fresno
Pacific Hematology Oncology Associates, San Francisco
California Cancer Care, Inc., Greenbrae
Medical Oncology Hematology, Gilroy
Willamette Valley Cancer Institute and Research Center, Eugene
Virginia Mason Medical Center, Seattle
Rockwood Cancer Treatment Center, Spokane
Medical Oncology Associates, PS, Spokane
Cancer Research Center n.a. N.N. Blokhin, Moscow
City Oncology Hospital # 62, Moscow
Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan, Kazan'
Arizona Center for Hematology Oncology, Glendale
Providence Health System, Beverly Hills
Rocky Mountain Cancer Centers, LLP, Denver
Hematology Oncology Associates, P.C., Stamford
Berkshire Hematology Oncology, PC, Pittsfield
Englewood Hospital and Medical Center, Englewood
Texas Oncology - Plano East, Plano
Texas Oncology - Tyler, Tyler
Royal Victoria Hospital, Barrie
Grand River Regional Cancer Centre, Kitchener
Princess Margaret Hospital, Toronto
Jewish General Hospital, Montreal
Städtisches Krankenhaus Martha-Maria Halle Dölau gGmbH, Halle
Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital Dzieciecy, Torun
Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie w Warszawie, Warsaw
Specjalistyczny Szpital im. Alfreda Sokolowskiego, Szczecin
Hospital General Vall d'Hebron, Barcelona, Barcelona
Hospital Clinic i Provincial de Barcelona, Barcelona
Hospital Germans Trías i Pujol, Barcelona
Lead Sponsor
Morphotek
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