An Extension Study to Provide Continued Bevacizumab Therapy to Participants With Solid Tumors Who Were Previously Enrolled in a Roche/Genentech Sponsored Study
NCT ID: NCT01588184
Last Updated: 2020-11-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
95 participants
INTERVENTIONAL
2012-07-13
2019-09-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Breast Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
Bevacizumab
Bevacizumab will be administered at 7.5 or 15 milligrams per kilogram (mg/kg) intravenously every 3 weeks (Q3W), or 5 or 10 mg/kg intravenously every 2 weeks (Q2W).
Ovarian Cancer or Peritoneal Carcinoma
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
Bevacizumab
Bevacizumab will be administered at 7.5 or 15 milligrams per kilogram (mg/kg) intravenously every 3 weeks (Q3W), or 5 or 10 mg/kg intravenously every 2 weeks (Q2W).
Renal Cell Carcinoma
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
Bevacizumab
Bevacizumab will be administered at 7.5 or 15 milligrams per kilogram (mg/kg) intravenously every 3 weeks (Q3W), or 5 or 10 mg/kg intravenously every 2 weeks (Q2W).
Colorectal Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
Bevacizumab
Bevacizumab will be administered at 7.5 or 15 milligrams per kilogram (mg/kg) intravenously every 3 weeks (Q3W), or 5 or 10 mg/kg intravenously every 2 weeks (Q2W).
Non-Squamous, Non-Small Cell Lung Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
Bevacizumab
Bevacizumab will be administered at 7.5 or 15 milligrams per kilogram (mg/kg) intravenously every 3 weeks (Q3W), or 5 or 10 mg/kg intravenously every 2 weeks (Q2W).
Glioblastoma Multiforme
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
Bevacizumab
Bevacizumab will be administered at 7.5 or 15 milligrams per kilogram (mg/kg) intravenously every 3 weeks (Q3W), or 5 or 10 mg/kg intravenously every 2 weeks (Q2W).
Interventions
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Bevacizumab
Bevacizumab will be administered at 7.5 or 15 milligrams per kilogram (mg/kg) intravenously every 3 weeks (Q3W), or 5 or 10 mg/kg intravenously every 2 weeks (Q2W).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eligible for continuation of bevacizumab treatment at the end of a parent trial, according to parent trial protocol
* Able to comply with this extension study protocol (MO25757)
Exclusion Criteria
* Evidence of any adverse event potentially attributable to bevacizumab, for which the local label recommends permanent discontinuation
* A treatment interruption with bevacizumab of more than 42 days since the last administration of bevacizumab in the parent trial
* Evidence of any other disease that would put the participant at high risk for treatment-related complications
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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A.Ö. LKH; Abt. für Lungenkrankheiten
Steyr, , Austria
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
Goiânia, Goiás, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
Hospital Perola Byington
São Paulo, São Paulo, Brazil
Hospital A. C. Camargo; Oncologia
São Paulo, São Paulo, Brazil
Hospital Sao Jose
São Paulo, São Paulo, Brazil
MBAL Serdika EOOD
Sofia, , Bulgaria
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto, Ontario, Canada
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, , Czechia
North Estonia Medical Centre Foundation; Oncology Center
Tallinn, , Estonia
HOPITAL JEAN MINJOZ; Oncologie
Besançon, , France
Centre Leonard De Vinci;Chimiotherapie
Dechy, , France
Centre Georges François Leclerc; Service Pharmacie, Bp 77980
Dijon, , France
Hopital Roger Salengro; Service de Neurologie
Lille, , France
Centre Leon Berard; Departement Oncologie Medicale
Lyon, , France
Centre Paul Strauss; Oncologie Medicale
Strasbourg, , France
Hopital Larrey; Pneumologie
Toulouse, , France
Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie
Frankfurt am Main, , Germany
LungenClinic Großhansdorf GmbH
Großhansdorf, , Germany
Orszagos Onkologiai Intezet; Nogyogyaszati Osztaly
Budapest, , Hungary
Ospedale Antonio Perrino; Oncologia Medica
Brindisi, Apulia, Italy
A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica
Napoli, Campania, Italy
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
Bologna, Emilia-Romagna, Italy
Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1
Rome, Lazio, Italy
Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica
Milan, Lombardy, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
Milan, Lombardy, Italy
ASST DI MONZA; Oncologia Medica
Monza, Lombardy, Italy
ASST LARIANA; Oncologia
S. Fermo Della Battaglia (CO), Lombardy, Italy
Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia
Turin, Piedmont, Italy
Centro Catanese Di Oncologia; Oncologia Medica
Catania, Sicily, Italy
Ospedale Nuovo Della Versilia; Divisione Di Oncologia Medica
Lido di Camaiore, Tuscany, Italy
A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
Pisa, Tuscany, Italy
Ospedale Misericordia E Dolce; Oncologia Medica
Prato, Tuscany, Italy
Instituto Nacional de Cancerologia; Oncology
Distrito Federal, , Mexico
Fundación Rodolfo Padilla Padilla, A.C.; Oncology
León, , Mexico
Oaxaca Site Management Organization
Oaxaca City, , Mexico
Radboud Ziekenhuis; Urologie, 659
Nijmegen, , Netherlands
Leyenburg Hospital; Pulmonology
The Hague, , Netherlands
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj-Napoca, , Romania
Euroclinic Center of Oncology SRL
Iași, , Romania
Altai Region Oncology Dispensory; Oncology
Barnaul, , Russia
Regional Oncology Hospital; Oncology
Irkutsk, , Russia
Blokhin Cancer Research Center; Combined Treatment
Moscow, , Russia
Russian Research Center of Roentgenoradiology; Dept of Chemotherapy
Moscow, , Russia
P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept
Moscow, , Russia
City Clinical Oncology Hospital
Moscow, , Russia
Medical Radiological Scientific Center; Department of Radiotherapy of Gynaecological Disease
Obninsk, Kaluzhskaya Region, , Russia
Bashkirian Republican Clinical Oncology Dispensary
Ufa, , Russia
Vychodoslovensky onkologicky ustav
Košice, , Slovakia
Wits Donald Gordon Clinical Trial Centre; Medical Oncology
Parktown, Johannesburg, , South Africa
National Cancer Center; Medical Oncology
Gyeonggi-do, , South Korea
Severance Hospital; Internal Medicine
Seoul, , South Korea
Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology
Seoul, , South Korea
Hospital de Basurto; Servicio de Oncologia
Bilbao, Vizcaya, Spain
Hospital de Cruces; Servicio de Oncologia
Bilbao, Vizcaya, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
A Coruña, , Spain
Complejo Asistencial Universitario De Burgos; Servicio de Oncologia
Burgos, , Spain
Hospital Reina Sofia; Medical Oncology
Córdoba, , Spain
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
Jaén, , Spain
Hospital Gregorio Marañon
Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, , Spain
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
Málaga, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, , Spain
Mälarsjukhuset, Eskilstuna, Kvinnokliniken
Eskilstuna, , Sweden
Universitetssjukhuset Örebro, Onkologiska kliniken
Örebro, , Sweden
Norrlands universitetssjukhus; Onkologkliniken
Umeå, , Sweden
Adana City Hospital, Medical Oncology
Adana, , Turkey (Türkiye)
Addenbrooke'S Hospital; Dept of Neurosurgery
Cambridge, , United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
Manchester, , United Kingdom
North Wales Cancer Treatment Centre, Glan Clwyd Hospital
Rhyl, , United Kingdom
Countries
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References
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Oza AM, Dubois F, Hegg R, Hernandez CA, Finocchiaro G, Ghiringhelli F, Zamagni C, Nick S, Irahara N, Perretti T, Colombo N. A Long-Term Extension Study of Bevacizumab in Patients With Solid Tumors. Oncologist. 2021 Dec;26(12):e2254-e2264. doi: 10.1002/onco.13971. Epub 2021 Oct 4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2011-002009-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MO25757
Identifier Type: -
Identifier Source: org_study_id