Neoplasms Clinical Trial
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
Verified date | October 2020 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 95 |
Est. completion date | September 27, 2019 |
Est. primary completion date | September 27, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Austria | A.Ö. LKH; Abt. für Lungenkrankheiten | Steyr | |
Brazil | Hospital de Cancer de Barretos | Barretos | SP |
Brazil | Hospital Araujo Jorge; Departamento de Ginecologia E Mama | Goiania | GO |
Brazil | Hospital Sao Lucas - PUCRS | Porto Alegre | RS |
Brazil | Hospital A. C. Camargo; Oncologia | Sao Paulo | SP |
Brazil | Hospital Perola Byington | Sao Paulo | SP |
Brazil | Instituto do Cancer do Estado de Sao Paulo - ICESP | Sao Paulo | SP |
Brazil | Hospital Sao Jose | São Paulo | SP |
Bulgaria | MBAL Serdika EOOD | Sofia | |
Canada | University Health Network; Princess Margaret Hospital; Medical Oncology Dept | Toronto | Ontario |
Czechia | Fakultni nemocnice Olomouc; Onkologicka klinika | Olomouc | |
Estonia | North Estonia Medical Centre Foundation; Oncology Center | Tallinn | |
France | HOPITAL JEAN MINJOZ; Oncologie | Besancon | |
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 | |
Germany | Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie | Frankfurt am Main | |
Germany | LungenClinic Großhansdorf GmbH | Großhansdorf | |
Hungary | Orszagos Onkologiai Intezet; Nogyogyaszati Osztaly | Budapest | |
Italy | Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica | Bologna | Emilia-Romagna |
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 | Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica | Milano | Lombardia |
Italy | Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica | Milano | Lombardia |
Italy | ASST DI MONZA; Oncologia Medica | Monza | Lombardia |
Italy | A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica | Napoli | Campania |
Italy | A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii | Pisa | Toscana |
Italy | Ospedale Misericordia E Dolce; Oncologia Medica | Prato | Toscana |
Italy | Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1 | Roma | Lazio |
Italy | ASST LARIANA; Oncologia | S. Fermo Della Battaglia (CO) | Lombardia |
Italy | Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia | Torino | Piemonte |
Korea, Republic of | National Cancer Center; Medical Oncology | Gyeonggi-do | |
Korea, Republic of | Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology | Seoul | |
Korea, Republic of | Severance Hospital; Internal Medicine | Seoul | |
Mexico | Instituto Nacional de Cancerologia; Oncology | Distrito Federal | |
Mexico | Fundación Rodolfo Padilla Padilla, A.C.; Oncology | Leon | |
Mexico | Oaxaca Site Management Organization | Oaxaca | |
Netherlands | Leyenburg Hospital; Pulmonology | Den Haag | |
Netherlands | Radboud Ziekenhuis; Urologie, 659 | Nijmegen | |
Romania | Prof. Dr. I. Chiricuta Institute of Oncology | Cluj Napoca | |
Romania | Euroclinic Center of Oncology SRL | Iasi | |
Russian Federation | Altai Region Oncology Dispensory; Oncology | Barnaul | |
Russian Federation | Regional Oncology Hospital; Oncology | Irkutsk | |
Russian Federation | Blokhin Cancer Research Center; Combined Treatment | Moscow | |
Russian Federation | City Clinical Oncology Hospital | Moscow | |
Russian Federation | P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept | 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 | |
Slovakia | Vychodoslovensky onkologicky ustav | Košice | |
South Africa | Wits Donald Gordon Clinical Trial Centre; Medical Oncology | Parktown, Johannesburg | |
Spain | Hospital de Basurto; Servicio de Oncologia | Bilbao | Vizcaya |
Spain | Hospital de Cruces; Servicio de Oncologia | Bilbao | Vizcaya |
Spain | Complejo Asistencial Universitario De Burgos; Servicio de Oncologia | Burgos | |
Spain | Hospital Reina Sofia; Medical Oncology | Cordoba | |
Spain | Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia | Jaen | |
Spain | Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología | La Coruña | |
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 | Malaga | |
Spain | Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia | Valencia | |
Sweden | Mälarsjukhuset, Eskilstuna, Kvinnokliniken | Eskilstuna | |
Sweden | Universitetssjukhuset Örebro, Onkologiska kliniken | Örebro | |
Sweden | Norrlands universitetssjukhus; Onkologkliniken | Umeå | |
Turkey | Adana City Hospital, Medical Oncology | Adana | |
United Kingdom | 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 |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Austria, Brazil, Bulgaria, Canada, Czechia, Estonia, France, Germany, Hungary, Italy, Korea, Republic of, Mexico, Netherlands, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With Adverse Events | 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. | Baseline up to approximately 81 months | |
Secondary | Progression Free Survival (PFS) | 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. | Baseline up to approximately 81 months | |
Secondary | Overall Survival (OS) | Overall survival time is defined as the time from first dose of Bevacizumab in the E-trial to death from any cause. | Baseline up to approximately 81 months |
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