A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung
NCT ID: NCT01218516
Last Updated: 2020-08-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
130 participants
INTERVENTIONAL
2011-06-27
2013-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Farletuzumab plus Chemotherapy
During Combination Therapy, farletuzumab will be given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Participants who experience clinical benefit from the Combination Therapy will enter the Monotherapy Phase and receive farletuzumab as monotherapy until disease progression.
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.
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.
Placebo plus Chemotherapy
During Combination Therapy, placebo will be given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Participants who experience clinical benefit from the Combination Therapy will enter the Monotherapy Phase and receive placebo as monotherapy 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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed folate receptor-alpha (FRA) expression by immunohistochemistry (IHC)
* Measurable disease with at least one unidimensionally measurable lesion according to RECIST criteria version 1.1 by computed tomography (CT) or magnetic resonance imaging (MRI) scans (CT or MRI scans must have been performed within 30 days prior to the first dose of farletuzumab or placebo)
* Must have received no prior chemotherapy, radiation therapy or surgery with curative intent for adenocarcinoma of the lung
Exclusion Criteria
* Prior surgery with curative intent for adenocarcinoma of the lung
* Prior radiotherapy for adenocarcinoma of the lung. (Prior treatment with local radiotherapy for symptom control \[i.e., palliative radiation with non-curative intent\] is permitted)
18 Years
ALL
No
Sponsors
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Morphotek
INDUSTRY
Responsible Party
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Locations
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Ironwood Cancer and Research Center
Chandler, Arizona, United States
Arizona Center for Hematology Oncology
Glendale, Arizona, United States
Providence Health System
Beverly Hills, California, United States
Cancer Care Associates of Fresno Medical Group, Inc.
Fresno, California, United States
Medical Oncology Hematology
Gilroy, California, United States
California Cancer Care, Inc.
Greenbrae, California, United States
Moores University of California San Diego Cancer Center
La Jolla, California, United States
Wilshire Medical Oncology Group
La Verne, California, United States
Glendale Adventist Medical Center
Los Angeles, California, United States
Clinical Trials and Research Associates, Inc.
Montebello, California, United States
North Country Oncology-Hematology
Oceanside, California, United States
Pacific Hematology Oncology Associates
San Francisco, California, United States
Central Coast Medical Oncology
Santa Maria, California, United States
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States
Hematology Oncology Associates, P.C.
Stamford, Connecticut, United States
Center for Hematology-Oncology
Boca Raton, Florida, United States
Medical Specialists of the Palm Beaches
Deerfield Beach, Florida, United States
Broward General Medical Center
Fort Lauderdale, Florida, United States
Cancer Care of North Florida
Lake City, Florida, United States
Florida Cancer Institute-New Hope
New Port Richey, Florida, United States
Ocala Oncology Center, PL
Ocala, Florida, United States
MD Anderson Cancer Center-Orlando
Orlando, Florida, United States
University Hematology Oncology, Inc.
Centralia, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Deaconess Clinic Downtown
Evansville, Indiana, United States
The Community Hospital
Munster, Indiana, United States
Kentucky Cancer Center
Hazard, Kentucky, United States
Baptist Health System, Inc.
Lexington, Kentucky, United States
Christus Saint Frances, Cabrini Hospital, Cabrini Cancer Center
Alexandria, Louisiana, United States
Hematology and Oncology Specialists, LLC
Metairie, Louisiana, United States
National Cancer Institute
Bethesda, Maryland, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States
Berkshire Hematology Oncology, PC
Pittsfield, Massachusetts, United States
Detroit Clinical Research Center
Farmington Hills, Michigan, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, United States
Queens Hospital Center
Jamaica, New York, United States
Syracuse Veterns Affairs Medical Center
Syracuse, New York, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States
St. Luke's Cancer Center Associates
Bethlehem, Pennsylvania, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Texas Oncology - Bedford
Bedford, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Houston Cancer Institute
Houston, Texas, United States
Texas Oncology - Plano East
Plano, Texas, United States
Northwest Cancer Center
Sugar Land, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States
Texas Oncology - Waco
Waco, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Delta Hematology Oncology Associates, PC
Portsmouth, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Rockwood Cancer Treatment Center
Spokane, Washington, United States
Medical Oncology Associates, PS
Spokane, Washington, United States
Cancer Team Bellin Health
Green Bay, Wisconsin, United States
The Tweed Hospital
Tweed Heads, New South Wales, Australia
Southern Medical Day Oncology Care Centre
Wollongong, New South Wales, Australia
Royal Brisbane and Women's Hospital, Dept. of Medical Oncology
Brisbane, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital, Cancer Centre
Adelaide, South Australia, Australia
Flinders Medical Centre, Dept. of Oncology
Bedford Park, South Australia, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Frankston Hospital, Oncology Day Unit
Frankston, Victoria, Australia
Epworth Healthcare
Richmond, Victoria, Australia
Fremantle Hospital
Fremantle, Western Australia, Australia
Royal Victoria Hospital
Barrie, Ontario, Canada
Grand River Regional Cancer Centre
Kitchener, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Klinik Löwenstein gGmbH
Löwenstein, Baden-Wurttemberg, Germany
Asklepios Fachkliniken München-Gauting
Gauting, Bavaria, Germany
Krankenhaus Nordwest GmbH
Frankfurt am Main, Hesse, Germany
Johannes-Wesling-Klinikum Minden
Minden, North Rhine-Westphalia, Germany
Städtisches Krankenhaus Martha-Maria Halle Dölau gGmbH
Halle, Saxony-Anhalt, Germany
HELIOS Klinikum Emil von Behring
Berlin, , Germany
Asklepios Klinik Harburg
Hamburg, , Germany
Ospedale Unico Versilia
Lido di Camaiore, Lucca, Italy
Azienda Ospedaliero-Univesitaria "San Luigi Gonzaga"
Orbassano, Torino, Italy
Istituto Nazionale per la Ricerca sul Cancro
Genova, , Italy
A.O. Seconda Università degli Studi di Napoli
Napoli, , Italy
Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital Dzieciecy
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie w Warszawie
Warsaw, Masovian Voivodeship, Poland
Specjalistyczny Szpital im. Alfreda Sokolowskiego
Szczecin, West Pomeranian Voivodeship, Poland
Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan
Kazan', Tatarstan Republic, Russia
Cancer Research Center n.a. N.N. Blokhin
Moscow, , Russia
City Oncology Hospital # 62
Moscow, , Russia
Hospital Regional Carlos Haya
Málaga, Malaga, Spain
Hospital General Vall d'Hebron, Barcelona
Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
Hospital Germans Trías i Pujol
Barcelona, , Spain
Fundación Jiménez Díaz
Madrid, , Spain
Countries
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Other Identifiers
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2010-022229-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MORAb-003-009
Identifier Type: -
Identifier Source: org_study_id
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