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Brief Title: A Comparison of Continuous Bevacizumab (Avastin) Treatment or Placebo in Addition to Lomustine Followed by Standard of Care After Disease Progression in Participants With Glioblastoma
Official Title: A Double-Blind, Placebo-Controlled, Randomised, Phase II Study Evaluating the Efficacy and Safety of Addition of Continuous Multiple Line Bevacizumab Treatment to Lomustine in Second (2nd)-Line Followed by Standard of Care (SOC) in Third (3rd)-Line and Beyond Compared to Addition of Placebo, Following First Progression of Disease (PD1) in Patients With Glioblastoma (GBM) After First (1st)-Line Treatment With Radiotherapy, Temozolomide and Bevacizumab
Study ID: NCT01860638
Brief Summary: This multicenter, double-blind, placebo-controlled, randomized study will evaluate the efficacy and safety of the addition of bevacizumab treatment to lomustine (in 2nd-line \[2L\] treatment) and SOC (in 3rd-line \[3L\] and subsequent lines of treatment) following first-line disease progression (PD1) in participants with newly diagnosed glioblastoma. All enrolled participants will receive 1L treatment with radiotherapy, temozolomide, and bevacizumab. At PD1, eligible participants will be randomized (1:1) to receive 2L treatment with either bevacizumab plus lomustine or placebo plus lomustine. After second-line disease progression (PD2), participants will receive 3L treatment and will continue blinded bevacizumab or placebo with the addition of an SOC agent. Following third-line disease progression (PD3), participants will receive subsequent lines of treatment and will either continue blinded bevacizumab or placebo (at the discretion of the investigator), or switch to open-label bevacizumab (at the choice of the participant).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Medizinische Universität Graz; Universitätsklinik für Neurologie, Graz, , Austria
Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie, Innsbruck, , Austria
Kepler Universitätsklinikum GmbH - Neuromed Campus; Innere Medizin mit Neuroonkologie, Linz, , Austria
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt., Salzburg, , Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie, Wien, , Austria
Kaiser-Franz-Josef-Spital; Neurologische Abteilung, Wien, , Austria
MBAL Serdika EOOD, Sofia, , Bulgaria
Tom Baker Cancer Centre; Dept of Medicine, Calgary, Alberta, Canada
McGill University; Montreal Neurological Institute; Oncology, Montreal, Quebec, Canada
Clinical Hospital Centre Zagreb, Zagreb, , Croatia
Tartu University Hospital; Clinic of Hematology and Oncology, Tartu, , Estonia
HOPITAL JEAN MINJOZ; Oncologie, Besancon, , France
Hopital Avicenne; Neurologie, Bobigny, , France
Hopital Saint Andre; Département de Radiothérapie Et D'Oncologie Médicale, Bordeaux, , France
Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie, Bron, , France
Hopital Cote De Nacre; Unite Neurologie Generale, Caen, , France
Centre Georges Francois Leclerc; Oncologie 3, Dijon, , France
Hopital Roger Salengro; Service de Neurologie, Lille, , France
Hopital de La Timone - CHU de Marseille; Service de neuro-oncologie - Hôpital Adultes - 12ème étage, Marseille, , France
Hôpital Central; Departement de Neuro-Oncologie, Nancy, , France
Hopital Pitié Salpétrière - CHU; Service de neurologie 2 - Mazarin, Paris, , France
Hopital Purpan, Toulouse Cedex 9, , France
Agioi Anargyroi Anticancer Hospital; Radiotherapeutic Clinic, Kifisia, , Greece
Hygeia Hospital, Marousi, , Greece
Papageorgiou General Hospital; Medical Oncology, Thessaloniki, , Greece
Ospedale Bellaria; U.O. Oncologia Medica, Bologna, Emilia-Romagna, Italy
IFO - Istituto Regina Elena; Oncologia Medica, Roma, Lazio, Italy
Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica, Milano, Lombardia, Italy
Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia, Torino, Piemonte, Italy
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda, Padova, Veneto, Italy
Riga East Clinical University hospital, Clinic Gailezers, Dept of Neurosurgery, Riga, , Latvia
IPO de Coimbra; Servico de Oncologia Medica, Coimbra, , Portugal
Hospital de Santa Maria; Servico de Oncologia Medica, Lisboa, , Portugal
Hospital de Sao Joao; Servico de Oncologia, Porto, , Portugal
Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti, Bucuresti, , Romania
Institut Oncologic Ion Chiricuta; Departament Radioterapie, Cluj-napoca, , Romania
Spital Clinic Judetean Mures; Oncologie, Targu Mures, , Romania
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia, Badalona, Barcelona, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia, Córdoba, Cordoba, Spain
IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia, San Sebastian, Guipuzcoa, Spain
Hospital Universitario Son Espases; Servicio de Oncologia, Palma De Mallorca, Islas Baleares, Spain
Hospital de Cruces; Servicio de Oncologia, Bilbao, Vizcaya, Spain
Hospital Universitario Infanta Cristina; Servicio de Oncologia, Badajoz, , Spain
Hospital del Mar; Servicio de Oncologia, Barcelona, , Spain
Hospital Duran i Reynals; Oncologia, Barcelona, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid, , Spain
Hosp. Clinico San Carlos, Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario La Paz; 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
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia, Salamanca, , Spain
Universitetssjukhuset; Onkologkliniken, Linkoeping, , Sweden
Norrlands Universitetssjukhus; Cancer Centrum, Umea, , Sweden
Akademiska sjukhuset, Onkologkliniken, Uppsala, , Sweden
Adana City Hospital, Medical Oncology, Adana, , Turkey
Baskent Universitesi Tıp Fakultesi; Ic Hastalıkları Anabilim Dalı Tıbbi Onkoloji Bilim Dalı, Ankara, , Turkey
Dokuz Eylul Uni ; Medical Oncology, Izmir, , Turkey
Kocaeli University Faculty of Medicine; Medical oncology, Izmit, , Turkey
Bristol Haematology and Oncology Centre, Bristol, , United Kingdom
Addenbrookes Hospital; Dept of Oncology, Cambridge, , United Kingdom
University College Hospital; Department of Oncology, London, , United Kingdom
Christie Hospital Nhs Trust; Medical Oncology, Manchester, , United Kingdom
Royal Marsden Hospital; Dept of Medical Oncology, Sutton, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR