An Extension Study to Provide Continued Bevacizumab Therapy to Participants With Solid Tumors Who Were Previously Enrolled in a Roche/Genentech Sponsored Study

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01588184
• Other study ID #: MO25757
• Secondary ID: 2011-002009-31
• Status: Completed
• Phase: Phase 4
• Start date: July 13, 2012
• Est. completion date: September 27, 2019

Study information

• Verified date: October 2020
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• 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).

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

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, 

Outcome

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