NeoplasmsPhase 4NCT01588184
An Extension Study to Provide Continued Bevacizumab Therapy to Participants With Solid Tumors Who Were Previously Enrolled in a Roche/Genentech Sponsored Study
A Phase 4 study testing Bevacizumab in people with Neoplasms, run by Hoffmann-La Roche at 73 sites in 21 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 73 sitesin 21 countries
- Study dates
- 13 Jul 2012to 27 Sep 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
73 sites in 21 countries.
73 sites in 21 countries
Italy13 sites
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
Bologna, Emilia-Romagna, 40138
Ospedale Antonio Perrino; Oncologia Medica
Brindisi, Apulia, 72100
Centro Catanese Di Oncologia; Oncologia Medica
Catania, Sicily, 95126
Ospedale Nuovo Della Versilia; Divisione Di Oncologia Medica
Lido di Camaiore, Tuscany, 55043
Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica
Milan, Lombardy, 20133
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
Milan, Lombardy, 20141
ASST DI MONZA; Oncologia Medica
Monza, Lombardy, 20900
A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica
Naples, Campania, 80131
A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
Pisa, Tuscany, 56124
Ospedale Misericordia E Dolce; Oncologia Medica
Prato, Tuscany, 59100
Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1
Rome, Lazio, 00152
ASST LARIANA; Oncologia
S. Fermo Della Battaglia (CO), Lombardy, 22020
Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia
Turin, Piedmont, 10126
Spain11 sites
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
A Coruña, 15006
Hospital de Basurto; Servicio de Oncologia
Bilbao, Vizcaya, 48013
Hospital de Cruces; Servicio de Oncologia
Bilbao, Vizcaya, 48903
Complejo Asistencial Universitario De Burgos; Servicio de Oncologia
Burgos, 09006
Hospital Reina Sofia; Medical Oncology
Córdoba, 14004
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
Jaén, 23007
Hospital Gregorio Marañon
Madrid, 28007
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, 28041
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, 28046
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
Málaga, 29010
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, 46010
Russia8 sites
Altai Region Oncology Dispensory; Oncology
Barnaul, 656049
Regional Oncology Hospital; Oncology
Irkutsk, 664035
Blokhin Cancer Research Center; Combined Treatment
Moscow, 115478
Russian Research Center of Roentgenoradiology; Dept of Chemotherapy
Moscow, 117837
P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept
Moscow, 125284
City Clinical Oncology Hospital
Moscow, 143423
Medical Radiological Scientific Center; Department of Radiotherapy of Gynaecological Disease
Obninsk, Kaluzhskaya Region, 249034
Bashkirian Republican Clinical Oncology Dispensary
Ufa, 450054
Brazil7 sites
Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
Goiânia, Goiás, 74605-070
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, 01246-000
Hospital Perola Byington
São Paulo, São Paulo, 01317-000
Hospital A. C. Camargo; Oncologia
São Paulo, São Paulo, 01509-010
Hospital Sao Jose
São Paulo, São Paulo, CEP 01321-001
France7 sites
HOPITAL JEAN MINJOZ; Oncologie
Besançon, 25030
Centre Leonard De Vinci;Chimiotherapie
Dechy, 59187
Centre Georges François Leclerc; Service Pharmacie, Bp 77980
Dijon, 21000
Hopital Roger Salengro; Service de Neurologie
Lille
Centre Leon Berard; Departement Oncologie Medicale
Lyon, 69373
Centre Paul Strauss; Oncologie Medicale
Strasbourg, 67065
Hopital Larrey; Pneumologie
Toulouse, 31059
Mexico3 sites
Instituto Nacional de Cancerologia; Oncology
Distrito Federal, 14080
Fundación Rodolfo Padilla Padilla, A.C.; Oncology
León, 37000
Oaxaca Site Management Organization
Oaxaca City, 68000
South Korea3 sites
National Cancer Center; Medical Oncology
Gyeonggi-do, 410-769
Severance Hospital; Internal Medicine
Seoul, 110-744
Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology
Seoul, 138-736
Sweden3 sites
Mälarsjukhuset, Eskilstuna, Kvinnokliniken
Eskilstuna, 63188
Universitetssjukhuset Örebro, Onkologiska kliniken
Örebro, 701 85
Norrlands universitetssjukhus; Onkologkliniken
Umeå
United Kingdom3 sites
Addenbrooke'S Hospital; Dept of Neurosurgery
Cambridge, CB2 2QQ
Christie Hospital Nhs Trust; Medical Oncology
Manchester, M2O 4BX
North Wales Cancer Treatment Centre, Glan Clwyd Hospital
Rhyl, LL18 5UJ
Germany2 sites
Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie
Frankfurt am Main, 60528
LungenClinic Großhansdorf GmbH
Großhansdorf, 22927
Netherlands2 sites
Radboud Ziekenhuis; Urologie, 659
Nijmegen, 6525 GA
Leyenburg Hospital; Pulmonology
The Hague, 2504 LN
Romania2 sites
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj-Napoca, 400015
Euroclinic Center of Oncology SRL
Iași, 700106
Canada1 site
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto, Ontario, M5G 2M9
Estonia1 site
North Estonia Medical Centre Foundation; Oncology Center
Tallinn, 13419
Hungary1 site
Orszagos Onkologiai Intezet; Nogyogyaszati Osztaly
Budapest, 1122
South Africa1 site
Wits Donald Gordon Clinical Trial Centre; Medical Oncology
Parktown, Johannesburg, 2193
Turkey (Türkiye)1 site
Adana City Hospital, Medical Oncology
Adana, 01060
About this 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
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.
- Conditions
- Neoplasms
- Being tested
- Bevacizumab
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
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).
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer | Experimental | Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Receives: Drug: Bevacizumab |
| Ovarian Cancer or Peritoneal Carcinoma | Experimental | Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Receives: Drug: Bevacizumab |
| Renal Cell Carcinoma | Experimental | Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Receives: Drug: Bevacizumab |
| Colorectal Cancer | Experimental | Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Receives: Drug: Bevacizumab |
| Non-Squamous, Non-Small Cell Lung Cancer | Experimental | Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Receives: Drug: Bevacizumab |
| Glioblastoma Multiforme | Experimental | Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to approximately 81 months
Secondary outcomes (2)
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.
Measured: Baseline up to approximately 81 months
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.
Measured: Baseline up to approximately 81 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study start13 Jul 2012
- Primary completion27 Sep 2019
- Study completion27 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- All participants were assigned the same treatment. The Number of Arms represent the reporting groups of all subjects according to disease.
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588184
- Sponsor's protocol ID
- MO25757
- Other IDs
- 2011-002009-31
- Status last verified
- Oct 2020
- First submitted
- 26 Apr 2012
- Last updated
- 5 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 34498344
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01588184
- Acronym / sponsor ID
- MO25757
- Conditions
- Neoplasms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2012 (actual)
- Primary completion
- 27 Sep 2019 (actual)
- Study completion
- 27 Sep 2019 (actual)
- First posted
- 30 Apr 2012 (estimated)
- Results
- Posted 5 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- All participants were assigned the same treatment. The Number of Arms represent the reporting groups of all subjects according to disease.
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer | Experimental | Drug: BevacizumabParticipants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. |
| Ovarian Cancer or Peritoneal Carcinoma | Experimental | Drug: BevacizumabParticipants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. |
| Renal Cell Carcinoma | Experimental | Drug: BevacizumabParticipants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. |
| Colorectal Cancer | Experimental | Drug: BevacizumabParticipants 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 | Experimental | Drug: BevacizumabParticipants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. |
| Glioblastoma Multiforme | Experimental | Drug: BevacizumabParticipants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: AvastinBevacizumab 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). | Drug | Breast Cancer, Colorectal Cancer, Glioblastoma Multiforme, Non-Squamous, Non-Small Cell Lung Cancer, Ovarian Cancer or Peritoneal Carcinoma, Renal Cell Carcinoma |
Primary outcome
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.
2 secondary outcomes
Progression Free Survival (PFS)
Time frame: Baseline up to approximately 81 months
Overall Survival (OS)
Time frame: Baseline up to approximately 81 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34498344Oza 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
73 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bevacizumab in people with Neoplasms, run by Hoffmann-La Roche at 73 sites in 21 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in Italy, Spain, Russia, Brazil, France and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Adverse Events (time frame: Baseline up to approximately 81 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01588184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.