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Brief Title: A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab Compared to Bevacizumab Alone or Onartuzumab Monotherapy in Participants With Recurrent Glioblastoma
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study Evaluating the Efficacy and Safety of Onartuzumab in Combination With Bevacizumab or Onartuzumab Monotherapy in Patients With Recurrent Glioblastoma
Study ID: NCT01632228
Brief Summary: This randomized, double-blind, placebo-controlled, multicenter phase II study will evaluate the safety and efficacy of onartuzumab in combination with bevacizumab as compared to bevacizumab alone in participants with recurrent glioblastoma. Participants will be randomized 1:1 to receive either placebo plus bevacizumab every 3 weeks, or onartuzumab plus bevacizumab. Study treatment will continue until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama At Birmingham; Neuro-Oncology, Birmingham, Alabama, United States
Cedars Sinai Medical Center; Neurosurgery, Los Angeles, California, United States
UCLA, Los Angeles, California, United States
USCF - Neurosurgery, San Francisco, California, United States
Stanford Comprehensive Cancer Center, Stanford, California, United States
University of Colorado, Aurora, Colorado, United States
Florida Cancer Specialists - Englewood, Englewood, Florida, United States
Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building), Saint Petersburg, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
North Western Univ; Neurology, Chicago, Illinois, United States
Northshore University Health System; Cardiology, Evanston, Illinois, United States
Henry Ford Health System, Detroit, Michigan, United States
Duke University Medical Center, Durham, North Carolina, United States
Hatton Research Institutes, Cincinnati, Ohio, United States
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc, Nashville, Tennessee, United States
Baylor Research Inst., Dallas, Texas, United States
University of Virgina, Charlottesville, Virginia, United States
Virginia Cancer Institute, Richmond, Virginia, United States
Seattle Cancer Care Alliance; Investigational Drug Service, Seattle, Washington, United States
Hamilton Health Sciences - Juravinski Cancer Centre, Hamilton, Ontario, Canada
London Health Sciences Centre, London, Ontario, Canada
Sunnybrook Health Science Centre, Toronto, Ontario, Canada
Princess Margaret Hospital; Pencer Brain Tumour Centre, 18-727, Toronto, Ontario, Canada
McGill University; Montreal Neurological Institute; Oncology, Montreal, Quebec, Canada
CHUS Hopital Fleurimont; CRC, Sherbrooke, Quebec, Canada
Hopital Avicenne; Neurologie, Bobigny, , France
Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie, Bron, , France
Hopital Roger Salengro, Lille, , France
Hopital de La Timone - CHU de Marseille; Service de neuro-oncologie - Hôpital Adultes - 12ème étage, Marseille, , France
Centre Val Aurelle Paul Lamarque; Medecine B3, Montpellier, , France
Hôpital Central; Departement de Neuro-Oncologie, Nancy, , France
Hopital Pitié Salpétrière - CHU; Service de neurologie 2 - Mazarin, Paris, , France
Ico Rene Gauducheau; Oncologie, Saint Herblain, , France
Hopital Purpan, Toulouse Cedex 9, , France
Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin, Bonn, , Germany
Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie, Frankfurt am Main, , Germany
Universitatsklinikum Hamburg-Eppendorf; Klinik und Poliklinik fur Neurochirurgie, Hamburg, , Germany
Ärztehaus Velen, Ibbenbühren, , Germany
Universitätsklinikum Köln, Köln, , Germany
Klinikum der Johannes Gutenberg Uni Mainz; Studienz. Neurologie, Klinik und Poliklinik Neurologie, Mainz, , Germany
Uni Klinikum München - Großhardern; Med. Klinik U. Poliklinik III - Abt. Onkologie u. Hämatologie, München, , Germany
Pius-Hospital, Oldenburg, , Germany
Ospedale Bellaria; U.O. Oncologia Medica, Bologna, Emilia-Romagna, Italy
Presidio Ospedaliero Marconi Bufalini; U.O. di Oncologia, Cesena, Emilia-Romagna, Italy
A.O. Universitaria Di Parma; Oncologia Medica, Parma, Emilia-Romagna, Italy
Spedali Civili di Brescia, Brescia, Lombardia, Italy
Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia, Milano, Lombardia, Italy
Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica, Milano, Lombardia, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino, Piemonte, Italy
Az. Osp. Pisana Ospedale S. Chiara; U.O. Di Reumatologia, Pisa, Toscana, Italy
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia, Badalona, Barcelona, Spain
Clinica Universitaria de Navarra; Servicio de Oncologia, Pamplona, Navarra, Spain
Hospital Clinic i Provincial; Servicio de Farmacia, Barcelona, , Spain
Institut Catala d Oncologia Hospital Duran i Reynals, Barcelona, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid, , Spain
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia, Madrid, , Spain
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia, Malaga, , Spain
HUG; Oncologie, Geneve, , Switzerland
Universitätsspital Zürich; Klinik für Neurologie, Zürich, , Switzerland
Bristol Haematology and Oncology Centre, Bristol, , United Kingdom
Sarah Cannon Research Institute, London, , United Kingdom
Nottingham City Hospital; David Evans Centre, Nottingham, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR