Clinical trial NCT01588184: An Extension Study to Provide Continued Bevacizumab Therapy to Participants With Solid Tumors Who Were Previously Enrolled in a Roche/Genentech Sponsored Study
Official title: A Single Arm, Open Label Multicentre Extension Study of Bevacizumab in Patients With Solid Tumours on Study Treatment With Bevacizumab, at the End of A F. Hoffmann-La Roche and/or Genentech Sponsored Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-04-30
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All participants were assigned the same treatment. The Number of Arms represent the reporting groups of all subjects according to disease.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline up to approximately 81 months
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Baseline up to approximately 81 months
measure: Overall Survival (OS)
timeFrame: Baseline up to approximately 81 months
Other outcomes:
Locations:
city: Steyr
country: Austria
facility: A.Ö. LKH; Abt. für Lungenkrankheiten
city: Goiania
country: Brazil
facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama
state: GO
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS
state: RS
city: Barretos
country: Brazil
facility: Hospital de Cancer de Barretos
state: SP
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Perola Byington
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital A. C. Camargo; Oncologia
state: SP
city: São Paulo
country: Brazil
facility: Hospital Sao Jose
state: SP
city: Sofia
country: Bulgaria
facility: MBAL Serdika EOOD
city: Toronto
country: Canada
facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept
state: Ontario
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc; Onkologicka klinika
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation; Oncology Center
city: Besancon
country: France
facility: HOPITAL JEAN MINJOZ; Oncologie
city: Dechy
country: France
facility: Centre Leonard De Vinci;Chimiotherapie
city: Dijon
country: France
facility: Centre Georges François Leclerc; Service Pharmacie, Bp 77980
city: Lille
country: France
facility: Hopital Roger Salengro; Service de Neurologie
city: Lyon
country: France
facility: Centre Leon Berard; Departement Oncologie Medicale
city: Strasbourg
country: France
facility: Centre Paul Strauss; Oncologie Medicale
city: Toulouse
country: France
facility: Hopital Larrey; Pneumologie
city: Frankfurt am Main
country: Germany
facility: Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie
city: Großhansdorf
country: Germany
facility: LungenClinic Großhansdorf GmbH
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet; Nogyogyaszati Osztaly
city: Napoli
country: Italy
facility: A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica
state: Campania
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
state: Emilia-Romagna
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1
state: Lazio
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica
state: Lombardia
city: Milano
country: Italy
facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
state: Lombardia
city: Monza
country: Italy
facility: ASST DI MONZA; Oncologia Medica
state: Lombardia
city: S. Fermo Della Battaglia (CO)
country: Italy
facility: ASST LARIANA; Oncologia
state: Lombardia
city: Torino
country: Italy
facility: Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia
state: Piemonte
city: Brindisi
country: Italy
facility: Ospedale Antonio Perrino; Oncologia Medica
state: Puglia
city: Catania
country: Italy
facility: Centro Catanese Di Oncologia; Oncologia Medica
state: Sicilia
city: Lido Di Camaiore
country: Italy
facility: Ospedale Nuovo Della Versilia; Divisione Di Oncologia Medica
state: Toscana
city: Pisa
country: Italy
facility: A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
state: Toscana
city: Prato
country: Italy
facility: Ospedale Misericordia E Dolce; Oncologia Medica
state: Toscana
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center; Medical Oncology
city: Seoul
country: Korea, Republic of
facility: Severance Hospital; Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology
city: Distrito Federal
country: Mexico
facility: Instituto Nacional de Cancerologia; Oncology
city: Leon
country: Mexico
facility: Fundación Rodolfo Padilla Padilla, A.C.; Oncology
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization
city: Den Haag
country: Netherlands
facility: Leyenburg Hospital; Pulmonology
city: Nijmegen
country: Netherlands
facility: Radboud Ziekenhuis; Urologie, 659
city: Cluj Napoca
country: Romania
facility: Prof. Dr. I. Chiricuta Institute of Oncology
city: Iasi
country: Romania
facility: Euroclinic Center of Oncology SRL
city: Barnaul
country: Russian Federation
facility: Altai Region Oncology Dispensory; Oncology
city: Irkutsk
country: Russian Federation
facility: Regional Oncology Hospital; Oncology
city: Moscow
country: Russian Federation
facility: Blokhin Cancer Research Center; Combined Treatment
city: Moscow
country: Russian Federation
facility: Russian Research Center of Roentgenoradiology; Dept of Chemotherapy
city: Moscow
country: Russian Federation
facility: P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept
city: Moscow
country: Russian Federation
facility: City Clinical Oncology Hospital
city: Obninsk, Kaluzhskaya Region
country: Russian Federation
facility: Medical Radiological Scientific Center; Department of Radiotherapy of Gynaecological Disease
city: UFA
country: Russian Federation
facility: Bashkirian Republican Clinical Oncology Dispensary
city: Košice
country: Slovakia
facility: Vychodoslovensky onkologicky ustav
city: Parktown, Johannesburg
country: South Africa
facility: Wits Donald Gordon Clinical Trial Centre; Medical Oncology
city: Bilbao
country: Spain
facility: Hospital de Basurto; Servicio de Oncologia
state: Vizcaya
city: Bilbao
country: Spain
facility: Hospital de Cruces; Servicio de Oncologia
state: Vizcaya
city: Burgos
country: Spain
facility: Complejo Asistencial Universitario De Burgos; Servicio de Oncologia
city: Cordoba
country: Spain
facility: Hospital Reina Sofia; Medical Oncology
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
city: La Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
city: Madrid
country: Spain
facility: Hospital Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz; Servicio de Oncologia
city: Malaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
city: Eskilstuna
country: Sweden
facility: Mälarsjukhuset, Eskilstuna, Kvinnokliniken
city: Umeå
country: Sweden
facility: Norrlands universitetssjukhus; Onkologkliniken
city: Örebro
country: Sweden
facility: Universitetssjukhuset Örebro, Onkologiska kliniken
city: Adana
country: Turkey
facility: Adana City Hospital, Medical Oncology
city: Cambridge
country: United Kingdom
facility: Addenbrooke'S Hospital; Dept of Neurosurgery
city: Manchester
country: United Kingdom
facility: Christie Hospital Nhs Trust; Medical Oncology
city: Rhyl
country: United Kingdom
facility: North Wales Cancer Treatment Centre, Glan Clwyd Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.