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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.
  • - 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.

Exclusion Criteria:

  • - 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) - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01632228
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hoffmann-La Roche
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Trials
Principal Investigator Affiliation Hoffmann-La Roche
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Completed
Countries Canada, France, Germany, Italy, Spain, Switzerland, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Arms & Interventions

Arms

Experimental: Onartuzumab + Bevacizumab

All participants will receive onartuzumab intravenous (IV) infusion followed by bevacizumab IV infusion every 3 weeks.

Active Comparator: Placebo + Bevacizumab

All participants will receive placebo matched with onartuzumab followed by bevacizumab IV infusion every 3 weeks.

Interventions

Drug: - Bevacizumab

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.

Drug: - Onartuzumab

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.

Drug: - Placebo

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham, Alabama

Status

Address

University of Alabama At Birmingham; Neuro-Oncology

Birmingham, Alabama, 35294

Los Angeles, California

Status

Address

Cedars Sinai Medical Center; Neurosurgery

Los Angeles, California, 90048

UCLA, Los Angeles, California

Status

Address

UCLA

Los Angeles, California, 90095

USCF - Neurosurgery, San Francisco, California

Status

Address

USCF - Neurosurgery

San Francisco, California, 94143

Stanford Comprehensive Cancer Center, Stanford, California

Status

Address

Stanford Comprehensive Cancer Center

Stanford, California, 94305

University of Colorado, Aurora, Colorado

Status

Address

University of Colorado

Aurora, Colorado, 80045

Florida Cancer Specialists - Englewood, Englewood, Florida

Status

Address

Florida Cancer Specialists - Englewood

Englewood, Florida, 34223

Saint Petersburg, Florida

Status

Address

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

Saint Petersburg, Florida, 33705

Moffitt Cancer Center, Tampa, Florida

Status

Address

Moffitt Cancer Center

Tampa, Florida, 33647

North Western Univ; Neurology, Chicago, Illinois

Status

Address

North Western Univ; Neurology

Chicago, Illinois, 60611

Evanston, Illinois

Status

Address

Northshore University Health System; Cardiology

Evanston, Illinois, 60201

Henry Ford Health System, Detroit, Michigan

Status

Address

Henry Ford Health System

Detroit, Michigan, 48202

Duke University Medical Center, Durham, North Carolina

Status

Address

Duke University Medical Center

Durham, North Carolina, 27710

Hatton Research Institutes, Cincinnati, Ohio

Status

Address

Hatton Research Institutes

Cincinnati, Ohio, 45220

Nashville, Tennessee

Status

Address

Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

Nashville, Tennessee, 37203

Baylor Research Inst., Dallas, Texas

Status

Address

Baylor Research Inst.

Dallas, Texas, 75246

University of Virgina, Charlottesville, Virginia

Status

Address

University of Virgina

Charlottesville, Virginia, 22908

Virginia Cancer Institute, Richmond, Virginia

Status

Address

Virginia Cancer Institute

Richmond, Virginia, 23226

Seattle, Washington

Status

Address

Seattle Cancer Care Alliance; Investigational Drug Service

Seattle, Washington, 98101

International Sites

Hamilton, Ontario, Canada

Status

Address

Hamilton Health Sciences - Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2

London Health Sciences Centre, London, Ontario, Canada

Status

Address

London Health Sciences Centre

London, Ontario, N6A 4L6

Sunnybrook Health Science Centre, Toronto, Ontario, Canada

Status

Address

Sunnybrook Health Science Centre

Toronto, Ontario, M4N 3M5

Toronto, Ontario, Canada

Status

Address

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

Toronto, Ontario, M5G 2M9

Montreal, Quebec, Canada

Status

Address

McGill University; Montreal Neurological Institute; Oncology

Montreal, Quebec, H3A 2B4

CHUS Hopital Fleurimont; CRC, Sherbrooke, Quebec, Canada

Status

Address

CHUS Hopital Fleurimont; CRC

Sherbrooke, Quebec, J1H 5N4

Hopital Avicenne; Neurologie, Bobigny, France

Status

Address

Hopital Avicenne; Neurologie

Bobigny, , 93009

Bron, France

Status

Address

Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

Bron, , 69677

Hopital Roger Salengro, Lille, France

Status

Address

Hopital Roger Salengro

Lille, , 59037

Marseille, France

Status

Address

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

Marseille, , 13385

Montpellier, France

Status

Address

Centre Val Aurelle Paul Lamarque; Medecine B3

Montpellier, , 34298

Nancy, France

Status

Address

Hôpital Central; Departement de Neuro-Oncologie

Nancy, , 54000

Paris, France

Status

Address

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

Paris, , 75651

Ico Rene Gauducheau; Oncologie, Saint Herblain, France

Status

Address

Ico Rene Gauducheau; Oncologie

Saint Herblain, , 44805

Hopital Purpan, Toulouse Cedex 9, France

Status

Address

Hopital Purpan

Toulouse Cedex 9, , 31059

Bonn, Germany

Status

Address

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

Bonn, , 53127

Frankfurt am Main, Germany

Status

Address

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

Frankfurt am Main, , 60528

Hamburg, Germany

Status

Address

Universitatsklinikum Hamburg-Eppendorf; Klinik und Poliklinik fur Neurochirurgie

Hamburg, , 20246

Ärztehaus Velen, Ibbenbühren, Germany

Status

Address

Ärztehaus Velen

Ibbenbühren, , 49479

Universitätsklinikum Köln, Köln, Germany

Status

Address

Universitätsklinikum Köln

Köln, , 50937

Mainz, Germany

Status

Address

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

Mainz, , 55131

München, Germany

Status

Address

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

München, , 81377

Pius-Hospital, Oldenburg, Germany

Status

Address

Pius-Hospital

Oldenburg, , 26121

Ospedale Bellaria; U.O. Oncologia Medica, Bologna, Emilia-Romagna, Italy

Status

Address

Ospedale Bellaria; U.O. Oncologia Medica

Bologna, Emilia-Romagna, 40133

Cesena, Emilia-Romagna, Italy

Status

Address

Presidio Ospedaliero Marconi Bufalini; U.O. di Oncologia

Cesena, Emilia-Romagna, 47023

Parma, Emilia-Romagna, Italy

Status

Address

A.O. Universitaria Di Parma; Oncologia Medica

Parma, Emilia-Romagna, 43100

Spedali Civili di Brescia, Brescia, Lombardia, Italy

Status

Address

Spedali Civili di Brescia

Brescia, Lombardia, 25123

Milano, Lombardia, Italy

Status

Address

Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia

Milano, Lombardia, 20122

Milano, Lombardia, Italy

Status

Address

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

Milano, Lombardia, 20133

Torino, Piemonte, Italy

Status

Address

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Torino, Piemonte, 10126

Pisa, Toscana, Italy

Status

Address

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

Pisa, Toscana, 56100

Badalona, Barcelona, Spain

Status

Address

Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

Badalona, Barcelona, 08916

Pamplona, Navarra, Spain

Status

Address

Clinica Universitaria de Navarra; Servicio de Oncologia

Pamplona, Navarra, 31008

Barcelona, Spain

Status

Address

Hospital Clinic i Provincial; Servicio de Farmacia

Barcelona, , 08036

Barcelona, Spain

Status

Address

Institut Catala d Oncologia Hospital Duran i Reynals

Barcelona, , 08908

Madrid, Spain

Status

Address

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, , 28034

Madrid, Spain

Status

Address

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

Madrid, , 28050

Malaga, Spain

Status

Address

Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

Malaga, , 29010

HUG; Oncologie, Geneve, Switzerland

Status

Address

HUG; Oncologie

Geneve, , 1211

Zürich, Switzerland

Status

Address

Universitätsspital Zürich; Klinik für Neurologie

Zürich, , 8091

Bristol Haematology and Oncology Centre, Bristol, United Kingdom

Status

Address

Bristol Haematology and Oncology Centre

Bristol, , BS2 8ED

Sarah Cannon Research Institute, London, United Kingdom

Status

Address

Sarah Cannon Research Institute

London, , W1G 6AD

Nottingham, United Kingdom

Status

Address

Nottingham City Hospital; David Evans Centre

Nottingham, , NG5 1PB