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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Conditions

Glioblastoma

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Clinical Trials

Affiliation: Hoffmann-La Roche

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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