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GlioblastomaPhase 2NCT01632228

A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab Compared to Bevacizumab Alone or Onartuzumab Monotherapy in Participants With Recurrent Glioblastoma

A Phase 2 study testing Bevacizumab and Onartuzumab in people with Glioblastoma, run by Hoffmann-La Roche at 62 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This randomized, double-blind, placebo-controlled, multicenter phase II study will evaluate the safety and efficacy of onartuzumab in combination with bevacizumab as compared to bevacizumab alone in participants with recurrent glioblastoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma
What is being tested?
Bevacizumab and Onartuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
135 participants
Where
62 sitesin 8 countries
Study dates
29 Jun 2012to 21 Jan 2016
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Histologically confirmed glioblastoma at first recurrence after concurrent or adjuvant chemoradiotherapy
  • Imaging confirmation of first tumor progression or regrowth as defined by RANO criteria
  • Prior treatment with temozolomide
  • No more than one prior line of chemotherapy
  • No prior treatment with bevacizumab or other vascular endothelial growth factor (VEGF)- or VEGF-receptor-targeted agent
  • No prior exposure to experimental treatment targeting either hepatocyte growth factor (HGF) or Met pathway
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  • No prior treatment with prolifeprospan 20 with carmustine wafer
  • No prior intracerebral agent
  • Recovery from the toxic effects of prior therapy
  • No evidence of recent hemorrhage on baseline magnetic resonance imaging (MRI) of the brain
  • No need for urgent palliative intervention for primary disease (e.g. impending herniation)
  • Karnofsky performance status greater than or equal to (>=) 70 percent (%)
  • Stable or decreasing dose of corticosteroids within 5 days prior to randomization
  • Prior therapy with gamma knife or other focal high-dose radiotherapy is allowed, but the participant must have subsequent histologic documentation of recurrence, unless the recurrence is a new lesion outside the irradiated field
  • Participants who have undergone recent surgery for recurrent or progressive tumor are eligible provided that: surgery must have confirmed the recurrence, a minimum of 28 days must have elapsed from the day of surgery to randomization and for core or needle biopsy, a minimum of 7 days must have elapsed prior to randomization, and craniotomy or intracranial biopsy site must be adequately healed and free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of randomization
  • Availability of formalin fixed paraffin embedded tumor tissue representative of glioblastoma

Who cannot join

  • Pregnant or lactating women
  • Inadequate hematologic, renal or liver function
  • History or presence of serious cardio-vascular disease
  • New York Heart Association Grade II or greater congestive heart failure
  • History of another malignancy in the previous 3 years, except for in situ cancer or basal or squamous cell skin cancer
  • Inadequately controlled hypertension (defined as systolic blood pressure greater than [>]150 millimeter of mercury (mmHg) and/or diastolic blood pressure >100 mmHg while on antihypertensive medication)
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  • Prior history of hypertensive crisis or hypertensive encephalopathy
  • Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to randomization
  • Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
  • Known hypersensitivity to any excipients of onartuzumab or bevacizumab

Trial locations and contacts

62 sites in 8 countries.

62 sites in 8 countries

United States19 sites

  • University of Colorado

    Aurora, Colorado, 80045

  • University of Alabama At Birmingham; Neuro-Oncology

    Birmingham, Alabama, 35294

  • University of Virgina

    Charlottesville, Virginia, 22908

  • North Western Univ; Neurology

    Chicago, Illinois, 60611

  • Hatton Research Institutes

    Cincinnati, Ohio, 45220

  • Baylor Research Inst.

    Dallas, Texas, 75246

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Florida Cancer Specialists - Englewood

    Englewood, Florida, 34223

  • Northshore University Health System; Cardiology

    Evanston, Illinois, 60201

  • Cedars Sinai Medical Center; Neurosurgery

    Los Angeles, California, 90048

  • UCLA

    Los Angeles, California, 90095

  • Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

    Nashville, Tennessee, 37203

  • Virginia Cancer Institute

    Richmond, Virginia, 23226

  • USCF - Neurosurgery

    San Francisco, California, 94143

  • Seattle Cancer Care Alliance; Investigational Drug Service

    Seattle, Washington, 98101

  • Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)

    St. Petersburg, Florida, 33705

  • Stanford Comprehensive Cancer Center

    Stanford, California, 94305

  • Moffitt Cancer Center

    Tampa, Florida, 33647

Other trials in United States

France9 sites

  • Hopital Avicenne; Neurologie

    Bobigny, 93009

  • Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

    Bron, 69677

  • Hopital Roger Salengro

    Lille, 59037

  • Hopital de La Timone - CHU de Marseille; Service de neuro-oncologie - Hôpital Adultes - 12ème étage

    Marseille, 13385

  • Centre Val Aurelle Paul Lamarque; Medecine B3

    Montpellier, 34298

  • Hôpital Central; Departement de Neuro-Oncologie

    Nancy, 54000

  • Hopital Pitié Salpétrière - CHU; Service de neurologie 2 - Mazarin

    Paris, 75651

  • Ico Rene Gauducheau; Oncologie

    Saint-Herblain, 44805

  • Hopital Purpan

    Toulouse, 31059

Other trials in France

Germany8 sites

  • Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin

    Bonn, 53127

  • Universitätsklinikum Köln

    Cologne, 50937

  • Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie

    Frankfurt am Main, 60528

  • Universitatsklinikum Hamburg-Eppendorf; Klinik und Poliklinik fur Neurochirurgie

    Hamburg, 20246

  • Ärztehaus Velen

    Ibbenbühren, 49479

  • Klinikum der Johannes Gutenberg Uni Mainz; Studienz. Neurologie, Klinik und Poliklinik Neurologie

    Mainz, 55131

  • Uni Klinikum München - Großhardern; Med. Klinik U. Poliklinik III - Abt. Onkologie u. Hämatologie

    München, 81377

  • Pius-Hospital

    Oldenburg, 26121

Other trials in Germany

Italy8 sites

  • Ospedale Bellaria; U.O. Oncologia Medica

    Bologna, Emilia-Romagna, 40133

  • Spedali Civili di Brescia

    Brescia, Lombardy, 25123

  • Presidio Ospedaliero Marconi Bufalini; U.O. di Oncologia

    Cesena, Emilia-Romagna, 47023

  • Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia

    Milan, Lombardy, 20122

  • Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica

    Milan, Lombardy, 20133

  • A.O. Universitaria Di Parma; Oncologia Medica

    Parma, Emilia-Romagna, 43100

  • Az. Osp. Pisana Ospedale S. Chiara; U.O. Di Reumatologia

    Pisa, Tuscany, 56100

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Turin, Piedmont, 10126

Other trials in Italy

Spain7 sites

  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

    Badalona, Barcelona, 08916

  • Hospital Clinic i Provincial; Servicio de Farmacia

    Barcelona, 08036

  • Institut Catala d Oncologia Hospital Duran i Reynals

    Barcelona, 08908

  • Hospital Ramon y Cajal; Servicio de Oncologia

    Madrid, 28034

  • HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

    Madrid, 28050

  • Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

    Málaga, 29010

  • Clinica Universitaria de Navarra; Servicio de Oncologia

    Pamplona, Navarre, 31008

Other trials in Spain

Canada6 sites

  • Hamilton Health Sciences - Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • London Health Sciences Centre

    London, Ontario, N6A 4L6

  • McGill University; Montreal Neurological Institute; Oncology

    Montreal, Quebec, H3A 2B4

  • CHUS Hopital Fleurimont; CRC

    Sherbrooke, Quebec, J1H 5N4

  • Sunnybrook Health Science Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital; Pencer Brain Tumour Centre, 18-727

    Toronto, Ontario, M5G 2M9

Other trials in Canada

United Kingdom3 sites

  • Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED

  • Sarah Cannon Research Institute

    London, W1G 6AD

  • Nottingham City Hospital; David Evans Centre

    Nottingham, NG5 1PB

Other trials in United Kingdom

Switzerland2 sites

  • HUG; Oncologie

    Geneva, 1211

  • Universitätsspital Zürich; Klinik für Neurologie

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study Evaluating the Efficacy and Safety of Onartuzumab in Combination With Bevacizumab or Onartuzumab Monotherapy in Patients With Recurrent Glioblastoma

This randomized, double-blind, placebo-controlled, multicenter phase II study will evaluate the safety and efficacy of onartuzumab in combination with bevacizumab as compared to bevacizumab alone in participants with recurrent glioblastoma. Participants will be randomized 1:1 to receive either placebo plus bevacizumab every 3 weeks, or onartuzumab plus bevacizumab. Study treatment will continue until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.

Conditions
Glioblastoma
Being tested
Bevacizumab, Onartuzumab, Placebo
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabDrug

    Participants will receive bevacizumab 15 milligrams per kilogram (mg/kg) IV infusion every 3 weeks until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.

  • OnartuzumabDrug

    Also called MetMAb, RO5490258

    Participants will receive onartuzumab 15 mg/kg IV infusion every 3 weeks until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.

  • PlaceboDrug

    Participants will receive placebo matched with onartuzumab until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.

Study groups in NCT01632228
Study groupRoleWhat they receive
Onartuzumab + BevacizumabExperimentalAll participants will receive onartuzumab intravenous (IV) infusion followed by bevacizumab IV infusion every 3 weeks.
Receives: Drug: Bevacizumab; Drug: Onartuzumab
Placebo + BevacizumabActive comparatorAll participants will receive placebo matched with onartuzumab followed by bevacizumab IV infusion every 3 weeks.
Receives: Drug: Bevacizumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS) as Assessed by Investigator According to Response Assessment in Neuro-Oncology (RANO) Criteria

    Measured: Baseline until disease progression, intolerable toxicity, participant or physician decision, or death, whichever occurs first (assessed every 6 weeks up to 18 months)

  2. Progression-free survival (PFS) as Assessed by Investigator According to RANO Criteria (in Participants With Met-Positive Glioblastoma)

    Measured: Baseline until disease progression, intolerable toxicity, participant or physician decision, or death, whichever occurs first (assessed every 6 weeks up to 18 months)

Secondary outcomes (17)

  1. Overall Survival (All Participants)

    Measured: Baseline until death (up to approximately 18 months)

  2. Percentage of Participants who Survived at Month 9 (All Participants)

    Measured: Month 9

  3. Percentage of Participants who are Progression Free at Month 6, as Assessed by RANO Criteria (All Participants)

    Measured: Month 6

  4. Percentage of Participants With Objective Response (OR), as Assessed by RANO Criteria (All Participants)

    Measured: Baseline until disease progression, intolerable toxicity, participant or physician decision, or death, whichever occurs first (assessed every 6 weeks up to 18 months)

  5. Duration of Response, as Assessed by RANO Criteria

    Measured: Baseline until disease progression, intolerable toxicity, participant or physician decision, or death, whichever occurs first (assessed every 6 weeks up to 18 months)

  6. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: Baseline up to approximately 3 years 8 months

  7. Percentage of Participants With Serum Anti-Therapeutic Antibody (ATAs) to Onartuzumab

    Measured: Predose (0 hour) on Day 1 of Cycles 1, 2, 3, 4, at study completion or study drug discontinuation visit (up to approximately 3.5 years; Cycle length: 21 days)

  8. Overall Survival (in Participants With Met-Positive Glioblastoma)

    Measured: Baseline until death (up to approximately 18 months)

  9. Percentage of Participants who Survived at Month 9 (in Participants With Met-Positive Glioblastoma)

    Measured: Month 9

  10. Percentage of Participants who are Progression Free at Month 6, as Assessed by RANO Criteria (in Participants With Met-Positive Glioblastoma)

    Measured: Month 6

  11. Percentage of Participants With Objective Response (OR), as Assessed by RANO Criteria (in Participants With Met-Positive Glioblastoma)

    Measured: Baseline until disease progression, intolerable toxicity, participant or physician decision, or death, whichever occurs first (assessed every 6 weeks up to 18 months)

  12. Duration of Response, as Assessed by RANO Criteria (in Participants With Met-Positive Glioblastoma)

    Measured: Baseline until disease progression, intolerable toxicity, participant or physician decision, or death, whichever occurs first (assessed every 6 weeks up to 18 months)

  13. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in Participants With Met-Positive Glioblastoma

    Measured: Baseline up to approximately 3 years 8 months

  14. Minimum Observed Serum Concentration (Cmin) of Onartuzumab

    Measured: predose (0 hour) on Day 1 of Cycles 1, 2, 3, 4, at study completion or study drug discontinuation visit (up to approximately 3.5 years) (Cycle length: 21 days; infusion duration: Onartuzumab 60 minutes)

  15. Maximum Observed Serum Concentration (Cmax) of Onartuzumab

    Measured: predose (0 hour) and 30 minutes post dose on Day 1 of Cycles 1, 2, 3, 4, at study completion or study drug discontinuation visit (up to approximately 3.5 years) (Cycle length: 21 days; infusion duration: Onartuzumab 60 minutes)

  16. Minimum Observed Serum Concentration (Cmin) of Bevacizumab

    Measured: predose (0 hour) on Day 1 of Cycles 1, 2, 3, 4, at study completion or study drug discontinuation visit (up to approximately 3.5 years) (Cycle length: 21 days; infusion duration: Bevacizumab 90 minutes)

  17. Maximum Observed Serum Concentration (Cmax) of Bevacizumab

    Measured: predose (0 hour) and 30 minutes post dose on Day 1 of Cycles 1, 2, 3, 4, at study completion or study drug discontinuation visit (up to approximately 3.5 years) (Cycle length: 21 days; infusion duration: Bevacizumab 90 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2012 (estimated)
  2. Study start29 Jun 2012
  3. Primary completion21 Jan 2016
  4. Study completion21 Jan 2016

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01632228
Sponsor's protocol ID
GO27819
Other IDs
2011-005912-27
Status last verified
Feb 2018
First submitted
28 Jun 2012
Last updated
5 Feb 2018
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab and Onartuzumab in people with Glioblastoma, run by Hoffmann-La Roche at 62 sites in 8 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 16 inclusion and 10 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 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, France, Germany, Italy, Spain and 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Progression-free survival (PFS) as Assessed by Investigator According to Response Assessment in Neuro-Oncology (RANO) Criteria (time frame: Baseline until disease progression, intolerable toxicity, participant or physician decision, or death, whichever occurs first (assessed every 6 weeks up to 18 months)). The study lists 2 primary outcomes in all. 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 NCT01632228.

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 Feb 2018.

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