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

October 15, 2020 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Steyr, Austria, 4400
        • A.Ö. LKH; Abt. für Lungenkrankheiten
  • Brazil
    • GO
      • Goiania, GO, Brazil, 74605-070
        • Hospital Araujo Jorge; Departamento de Ginecologia E Mama
    • RS
      • Porto Alegre, RS, Brazil, 90610-000
        • Hospital São Lucas - PUCRS
    • SP
      • Barretos, SP, Brazil, 14784-400
        • Hospital de Cancer de Barretos
      • Sao Paulo, SP, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP
      • Sao Paulo, SP, Brazil, 01317-000
        • Hospital Perola Byington
      • Sao Paulo, SP, Brazil, 01509-010
        • Hospital A. C. Camargo; Oncologia
      • São Paulo, SP, Brazil, CEP 01321-001
        • Hospital Sao Jose
  • Bulgaria
      • Sofia, Bulgaria, 1632
        • MBAL Serdika EOOD
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network; Princess Margaret Hospital; Medical Oncology Dept
  • Czechia
      • Olomouc, Czechia, 779 00
        • Fakultni nemocnice Olomouc; Onkologicka klinika
  • Estonia
      • Tallinn, Estonia, 13419
        • North Estonia Medical Centre Foundation; Oncology Center
  • France
      • Besancon, France, 25030
        • HOPITAL JEAN MINJOZ; Oncologie
      • Dechy, France, 59187
        • Centre Leonard De Vinci;Chimiotherapie
      • Dijon, France, 21000
        • Centre Georges François Leclerc; Service Pharmacie, Bp 77980
      • Lille, France
        • Hopital Roger Salengro; Service de Neurologie
      • Lyon, France, 69373
        • Centre Leon Berard; Departement Oncologie Medicale
      • Strasbourg, France, 67065
        • Centre Paul Strauss; Oncologie Medicale
      • Toulouse, France, 31059
        • Hopital Larrey; Pneumologie
  • Germany
      • Frankfurt am Main, Germany, 60528
        • Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie
      • Großhansdorf, Germany, 22927
        • LungenClinic Grosshansdorf GmbH
  • Hungary
      • Budapest, Hungary, 1122
        • Orszagos Onkologiai Intezet; Nogyogyaszati Osztaly
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
    • Lazio
      • Roma, Lazio, Italy, 00152
        • Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1
    • Lombardia
      • Milano, Lombardia, Italy, 20141
        • Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
      • Milano, Lombardia, Italy, 20133
        • Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica
      • Monza, Lombardia, Italy, 20900
        • ASST DI MONZA; Oncologia Medica
      • S. Fermo Della Battaglia (CO), Lombardia, Italy, 22020
        • ASST LARIANA; Oncologia
    • Piemonte
      • Torino, Piemonte, Italy, 10126
        • Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia
    • Puglia
      • Brindisi, Puglia, Italy, 72100
        • Ospedale Antonio Perrino; Oncologia Medica
    • Sicilia
      • Catania, Sicilia, Italy, 95126
        • Centro Catanese Di Oncologia; Oncologia Medica
    • Toscana
      • Lido Di Camaiore, Toscana, Italy, 55043
        • Ospedale Nuovo Della Versilia; Divisione Di Oncologia Medica
      • Pisa, Toscana, Italy, 56124
        • A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
      • Prato, Toscana, Italy, 59100
        • Ospedale Misericordia E Dolce; Oncologia Medica
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of, 410-769
        • National Cancer Center; Medical Oncology
      • Seoul, Korea, Republic of, 110-744
        • Severance Hospital; Internal Medicine
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology
  • Mexico
      • Distrito Federal, Mexico, 14080
        • Instituto Nacional de Cancerologia; Oncology
      • Leon, Mexico, 37000
        • Fundación Rodolfo Padilla Padilla, A.C.; Oncology
      • Oaxaca, Mexico, 68000
        • Oaxaca Site Management Organization
  • Netherlands
      • Den Haag, Netherlands, 2504 LN
        • Leyenburg Hospital; Pulmonology
      • Nijmegen, Netherlands, 6525 GA
        • Radboud Ziekenhuis; Urologie, 659
  • Romania
      • Cluj Napoca, Romania, 400015
        • Prof. Dr. I. Chiricuta Institute of Oncology
      • Iasi, Romania, 700106
        • Euroclinic Center of Oncology SRL
  • Russian Federation
      • Barnaul, Russian Federation, 656049
        • Altai Region Oncology Dispensory; Oncology
      • Irkutsk, Russian Federation, 664035
        • Regional Oncology Hospital; Oncology
      • Moscow, Russian Federation, 143423
        • City Clinical Oncology Hospital
      • Moscow, Russian Federation, 125284
        • P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept
      • Moscow, Russian Federation, 115478
        • Blokhin Cancer Research Center; Combined Treatment
      • Moscow, Russian Federation, 117837
        • Russian Research Center of Roentgenoradiology; Dept of Chemotherapy
      • Obninsk, Kaluzhskaya Region, Russian Federation, 249034
        • Medical Radiological Scientific Center; Department of Radiotherapy of Gynaecological Disease
      • UFA, Russian Federation, 450054
        • Bashkirian Republican Clinical Oncology Dispensary
  • Slovakia
      • Košice, Slovakia, 040 01
        • Východoslovenský Onkologický Ústav
  • South Africa
      • Parktown, Johannesburg, South Africa, 2193
        • Wits Donald Gordon Clinical Trial Centre; Medical Oncology
  • Spain
      • Burgos, Spain, 09006
        • Complejo Asistencial Universitario De Burgos; Servicio de Oncologia
      • Cordoba, Spain, 14004
        • Hospital Reina Sofia; Medical Oncology
      • Jaen, Spain, 23007
        • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
      • La Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre; Servicio de Oncologia
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz; Servicio de Oncologia
      • Madrid, Spain, 28007
        • Hospital Gregorio Marañón
      • Malaga, Spain, 29010
        • Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48903
        • Hospital de Cruces; Servicio de Oncologia
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital de Basurto; Servicio de Oncologia
  • Sweden
      • Eskilstuna, Sweden, 63188
        • Mälarsjukhuset, Eskilstuna, Kvinnokliniken
      • Umeå, Sweden
        • Norrlands universitetssjukhus; Onkologkliniken
      • Örebro, Sweden, 701 85
        • Universitetssjukhuset Örebro, Onkologiska kliniken
  • Turkey
      • Adana, Turkey, 01060
        • Adana City Hospital, Medical Oncology
  • United Kingdom
      • Cambridge, United Kingdom, CB2 2QQ
        • Addenbrooke'S Hospital; Dept of Neurosurgery
      • Manchester, United Kingdom, M2O 4BX
        • Christie Hospital Nhs Trust; Medical Oncology
      • Rhyl, United Kingdom, LL18 5UJ
        • North Wales Cancer Treatment Centre, Glan Clwyd Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breast Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
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).
Other Names:
  • Avastin
Experimental: Ovarian Cancer or Peritoneal Carcinoma
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
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).
Other Names:
  • Avastin
Experimental: Renal Cell Carcinoma
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
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).
Other Names:
  • Avastin
Experimental: Colorectal Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
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).
Other Names:
  • Avastin
Experimental: 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.
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).
Other Names:
  • Avastin
Experimental: Glioblastoma Multiforme
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
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).
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Adverse Events
Time Frame: 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.
Baseline up to approximately 81 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: 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.
Baseline up to approximately 81 months
Overall Survival (OS)
Time Frame: 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.
Baseline up to approximately 81 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2012

Primary Completion (Actual)

September 27, 2019

Study Completion (Actual)

September 27, 2019

Study Registration Dates

First Submitted

April 26, 2012

First Submitted That Met QC Criteria

April 26, 2012

First Posted (Estimate)

April 30, 2012

Study Record Updates

Last Update Posted (Actual)

November 5, 2020

Last Update Submitted That Met QC Criteria

October 15, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MO25757
  • 2011-002009-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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