A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC).
NCT ID: NCT00760929
Last Updated: 2021-01-05
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
171 participants
INTERVENTIONAL
2008-11-10
2010-06-25
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
DOUBLE
Study Groups
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Placebo for R1507 (16mg/kg iv)
Placebo
iv 16mg/kg every 3 weeks
erlotinib [Tarceva]
150mg oral daily
Placebo for R1507 (9mg/kg iv)
Placebo
iv 9mg/kg weekly
erlotinib [Tarceva]
150mg oral daily
R1507 (16mg/kg iv)
RG1507
iv 16mg/kg every 3 weeks
erlotinib [Tarceva]
150mg oral daily
R1507 (9mg/kg iv)
RG1507
iv 9mg/kg weekly
erlotinib [Tarceva]
150mg oral daily
Interventions
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Placebo
iv 9mg/kg weekly
Placebo
iv 16mg/kg every 3 weeks
RG1507
iv 9mg/kg weekly
RG1507
iv 16mg/kg every 3 weeks
erlotinib [Tarceva]
150mg oral daily
Eligibility Criteria
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Inclusion Criteria
* patients must have failed at least one but no more than two standard chemotherapy regimens;
* measurable disease according to the RECIST criteria;
* Eastern Cooperative Oncology Group (ECOG) performance status;
* life expectancy \>12 weeks.
Exclusion Criteria
* prior treatment with agents acting via insulin-like growth factor 1 receptor (IGF-1R) inhibition or epidermal growth factor receptor (EGFR) targeting;
* administration with high doses of systemic corticosteroids;
* radiotherapy in the 4 weeks prior to study start;
* surgery or significant traumatic injury with in the last 2 weeks prior to study start.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Tower Cancer Research Foundation
Beverly Hills, California, United States
Florida Cancer Inst.
New Port Richey, Florida, United States
Emory Univ Winship Cancer Inst
Atlanta, Georgia, United States
University of Chicago Medical Center; Dept. of Medicine/Section of Nephrology
Chicago, Illinois, United States
North Shore University Health System
Glenview, Illinois, United States
Joliet Oncology Hematology Associates, Ltd.
Joliet, Illinois, United States
St. Joseph Medical Center
Towson, Maryland, United States
Massachusetts General Hospital.
Boston, Massachusetts, United States
Dana Farber Cancer Inst.
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Carolina Oncology Specialists, PA - Hickory
Hickory, North Carolina, United States
Chattanooga Oncology and Hematology Associates, PC
Chattanooga, Tennessee, United States
Sarah Cannon Research Inst.
Nashville, Tennessee, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Flinders Medical Center; Medical Oncology
Adelaide, South Australia, Australia
Frankston Hospital; Oncology/Haematology
Frankston, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Cliniques Universitaires St-Luc
Brussels, , Belgium
GHdC Site Notre Dame
Charleroi, , Belgium
UZ Antwerpen
Edegem, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
Chr de La Citadelle
Liège, , Belgium
Lakeridge Health Oshawa; Oncology
Oshawa, Ontario, Canada
Hopital Albert Michallon; Medecine Aigue Specialisee Pneumologie
La Tronche, , France
Hopital de La Croix Rousse; Service de Pneumologie
Lyon, , France
Fondation Hopital Saint Joseph; Pole Cancerologie, Imagerie Medicale Service d'Oncologie
Paris, , France
Hopital Tenon;Pneumologie
Paris, , France
Hopital Larrey; Clinique Des Voies Respiratoires
Toulouse, , France
Zentralklinik Bad Berka GmbH; Pneumologie
Bad Berka, , Germany
Helios Klinikum Emil von Behring GmbH
Berlin, , Germany
LungenClinic Großhansdorf GmbH
Großhansdorf, , Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin I
Halle, , Germany
Asklepios Klinik Harburg; Thoraxzentrum
Hamburg, , Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg, , Germany
Stiftung Kathol. Krankenhaus Marienhospital Herne Klinik Mitte Frauenklinik
Herne, , Germany
Klinikum Leverkusen; Med. Klinik III / Onkologie
Leverkusen, , Germany
Ludwig-Maximilians Uni Klinik Innenstadt; Medizinische Klinik
München, , Germany
St. James Hospital; Oncology
Dublin, , Ireland
Arcispedale Santa Maria Nuova; Oncologia
Reggio Emilia, Emilia-Romagna, Italy
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
Genoa, Liguria, Italy
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
Milan, Lombardy, Italy
Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
Orbassano, Piedmont, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
Sant'Andrea Delle Fratte (PG), Umbria, Italy
Medical University of Gdansk
Gdansk, , Poland
SK Przemienienia Panskiego UM im.K.Marcinkowskiego
Poznan, , Poland
Specjalistyczny Szpital Im. Prof. A. Sokolowskiego; Oddziall Chemioterapii
Szczecin, , Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
Warsaw, , Poland
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
Majadahonda, Madrid, Spain
Hospital de Cruces; Servicio de Oncologia
Bilbao, Vizcaya, Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona, , Spain
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
Málaga, , Spain
Royal Surrey County Hospital; St. Lukes Cancer Centre
Guildford, , United Kingdom
Wythenshawe Hospital; North West Lung Centre
Manchester, , United Kingdom
Sir Bobby Robson Cancer Research Centre
Newcastle upon Tyne, , United Kingdom
New Cross Hospital; Deansley Centre
Wolverhampton, , United Kingdom
Countries
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References
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Ramalingam SS, Spigel DR, Chen D, Steins MB, Engelman JA, Schneider CP, Novello S, Eberhardt WE, Crino L, Habben K, Liu L, Janne PA, Brownstein CM, Reck M. Randomized phase II study of erlotinib in combination with placebo or R1507, a monoclonal antibody to insulin-like growth factor-1 receptor, for advanced-stage non-small-cell lung cancer. J Clin Oncol. 2011 Dec 1;29(34):4574-80. doi: 10.1200/JCO.2011.36.6799. Epub 2011 Oct 24.
Other Identifiers
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2008-001736-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NO21160
Identifier Type: -
Identifier Source: org_study_id
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