An Extension Study to Provide Continued Bevacizumab Therapy to Participants With Solid Tumors Who Were Previously Enrolled in a Roche/Genentech Sponsored Study
- Registration Number
- NCT01588184
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This single-arm, open-label, multicenter extension study will provide continued bevacizumab therapy to participants with solid tumors who were previously enrolled in a Roche/Genentech sponsored study and who derived benefit from the bevacizumab therapy. Participants will receive the same dose and regimen of bevacizumab as used in the previous parent trial and continue this treatment until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
- Participant is treated with bevacizumab at the end of the Roche/Genentech sponsored parent trial and continues to have benefit as judged by the investigator
- 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)
- Evidence of disease progression assessed according to parent trial protocol during the screening phase for this extension study
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Colorectal Cancer Bevacizumab Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Breast Cancer Bevacizumab Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Ovarian Cancer or Peritoneal Carcinoma Bevacizumab Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Glioblastoma Multiforme Bevacizumab Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Renal Cell Carcinoma Bevacizumab Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Non-Squamous, Non-Small Cell Lung Cancer Bevacizumab Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events Baseline up to approximately 81 months An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) Baseline up to approximately 81 months Progression free survival is defined as the time from first dose of Bevacizumab in this extension trial (E-trial) to the time of first documented disease progression or death due to any cause, whichever occurs first.
Overall Survival (OS) Baseline up to approximately 81 months Overall survival time is defined as the time from first dose of Bevacizumab in the E-trial to death from any cause.
Trial Locations
- Locations (73)
A.Ö. LKH; Abt. für Lungenkrankheiten
🇦🇹Steyr, Austria
Hospital Perola Byington
🇧🇷Sao Paulo, SP, Brazil
Hospital A. C. Camargo; Oncologia
🇧🇷Sao Paulo, SP, Brazil
North Estonia Medical Centre Foundation; Oncology Center
🇪🇪Tallinn, Estonia
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
🇨🇦Toronto, Ontario, Canada
HOPITAL JEAN MINJOZ; Oncologie
🇫🇷Besancon, France
Centre Leonard De Vinci;Chimiotherapie
🇫🇷Dechy, France
Centre Georges François Leclerc; Service Pharmacie, Bp 77980
🇫🇷Dijon, France
Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie
🇩🇪Frankfurt am Main, Germany
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
🇮🇹Bologna, Emilia-Romagna, Italy
Orszagos Onkologiai Intezet; Nogyogyaszati Osztaly
🇭🇺Budapest, Hungary
Centre Leon Berard; Departement Oncologie Medicale
🇫🇷Lyon, France
Hopital Larrey; Pneumologie
🇫🇷Toulouse, France
National Cancer Center; Medical Oncology
🇰🇷Gyeonggi-do, Korea, Republic of
Severance Hospital; Internal Medicine
🇰🇷Seoul, Korea, Republic of
Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology
🇰🇷Seoul, Korea, Republic of
Instituto Nacional de Cancerologia; Oncology
🇲🇽Distrito Federal, Mexico
Fundación Rodolfo Padilla Padilla, A.C.; Oncology
🇲🇽Leon, Mexico
Oaxaca Site Management Organization
🇲🇽Oaxaca, Mexico
Leyenburg Hospital; Pulmonology
🇳🇱Den Haag, Netherlands
Radboud Ziekenhuis; Urologie, 659
🇳🇱Nijmegen, Netherlands
Prof. Dr. I. Chiricuta Institute of Oncology
🇷🇴Cluj Napoca, Romania
Euroclinic Center of Oncology SRL
🇷🇴Iasi, Romania
Altai Region Oncology Dispensory; Oncology
🇷🇺Barnaul, Russian Federation
Regional Oncology Hospital; Oncology
🇷🇺Irkutsk, Russian Federation
P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept
🇷🇺Moscow, Russian Federation
Blokhin Cancer Research Center; Combined Treatment
🇷🇺Moscow, Russian Federation
City Clinical Oncology Hospital
🇷🇺Moscow, Russian Federation
Russian Research Center of Roentgenoradiology; Dept of Chemotherapy
🇷🇺Moscow, Russian Federation
Medical Radiological Scientific Center; Department of Radiotherapy of Gynaecological Disease
🇷🇺Obninsk, Kaluzhskaya Region, Russian Federation
Bashkirian Republican Clinical Oncology Dispensary
🇷🇺UFA, Russian Federation
Vychodoslovensky onkologicky ustav
🇸🇰Košice, Slovakia
Norrlands universitetssjukhus; Onkologkliniken
🇸🇪Umeå, Sweden
North Wales Cancer Treatment Centre, Glan Clwyd Hospital
🇬🇧Rhyl, United Kingdom
Hospital Universitario 12 de Octubre; Servicio de Oncologia
🇪🇸Madrid, Spain
Complejo Asistencial Universitario De Burgos; Servicio de Oncologia
🇪🇸Burgos, Spain
Hospital de Cruces; Servicio de Oncologia
🇪🇸Bilbao, Vizcaya, Spain
Christie Hospital Nhs Trust; Medical Oncology
🇬🇧Manchester, United Kingdom
Universitetssjukhuset Örebro, Onkologiska kliniken
🇸🇪Örebro, Sweden
Addenbrooke'S Hospital; Dept of Neurosurgery
🇬🇧Cambridge, United Kingdom
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
🇪🇸Jaen, Spain
Mälarsjukhuset, Eskilstuna, Kvinnokliniken
🇸🇪Eskilstuna, Sweden
Hospital Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Universitario La Paz; Servicio de Oncologia
🇪🇸Madrid, Spain
Wits Donald Gordon Clinical Trial Centre; Medical Oncology
🇿🇦Parktown, Johannesburg, South Africa
Adana City Hospital, Medical Oncology
🇹🇷Adana, Turkey
Hospital Reina Sofia; Medical Oncology
🇪🇸Cordoba, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
🇪🇸La Coruña, Spain
Hospital de Basurto; Servicio de Oncologia
🇪🇸Bilbao, Vizcaya, Spain
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
🇪🇸Malaga, Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
🇪🇸Valencia, Spain
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
🇧🇷Goiania, GO, Brazil
Hospital de Cancer de Barretos
🇧🇷Barretos, SP, Brazil
Hospital Sao Lucas - PUCRS
🇧🇷Porto Alegre, RS, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
🇧🇷Sao Paulo, SP, Brazil
MBAL Serdika EOOD
🇧🇬Sofia, Bulgaria
Fakultni nemocnice Olomouc; Onkologicka klinika
🇨🇿Olomouc, Czechia
LungenClinic Großhansdorf GmbH
🇩🇪Großhansdorf, Germany
Hopital Roger Salengro; Service de Neurologie
🇫🇷Lille, France
Centre Paul Strauss; Oncologie Medicale
🇫🇷Strasbourg, France
A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica
🇮🇹Napoli, Campania, Italy
Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica
🇮🇹Milano, Lombardia, Italy
Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1
🇮🇹Roma, Lazio, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
🇮🇹Milano, Lombardia, Italy
ASST DI MONZA; Oncologia Medica
🇮🇹Monza, Lombardia, Italy
ASST LARIANA; Oncologia
🇮🇹S. Fermo Della Battaglia (CO), Lombardia, Italy
Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia
🇮🇹Torino, Piemonte, Italy
Ospedale Antonio Perrino; Oncologia Medica
🇮🇹Brindisi, Puglia, Italy
Centro Catanese Di Oncologia; Oncologia Medica
🇮🇹Catania, Sicilia, Italy
Ospedale Nuovo Della Versilia; Divisione Di Oncologia Medica
🇮🇹Lido Di Camaiore, Toscana, Italy
A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
🇮🇹Pisa, Toscana, Italy
Ospedale Misericordia E Dolce; Oncologia Medica
🇮🇹Prato, Toscana, Italy
Hospital Sao Jose
🇧🇷São Paulo, SP, Brazil