Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02573324 : A Study of ABT-414 in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification
PhasePhase 3
AgesMin: 18 Years Max: 99 Years
Eligibility
Inclusion Criteria:

1. Must have a clinical diagnosis of Glioblastoma (GBM)

2. Must have a confirmed Epidermal growth factor receptor amplification in tumor tissue

3. Must have a Karnofsky Performance Status (KPS) >= 70 at assessment <= 14 days prior to
randomization (N/A to the sub-study).

4. Must have recovered from effects of surgery, postoperative infection and other
complications of surgery

5. Must have adequate bone marrow, renal, and hepatic function (For the sub-study, the
subject must have adequate bone marrow and renal function and have mild-to-moderate
hepatic impairment)

Exclusion Criteria:

1. Multifocal, recurrent or metastatic Glioblastoma (GBM) or gliomatosis cerebri (For the
sub-study, the subject can have multifocal GBM and glimatosis cerebri but can't have
recurrent or metastatic GBM)

2. Prior chemo therapy or radiosensitizer for head and neck cancer

3. Prior radiotherapy to the head or neck in overlap of radiation fields

4. Prior therapy for glioblastoma or other invasive malignancy

5. Prior, concomitant or planned treatment with Novo-TTF, EGFR-targeted therapy,
bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic
therapy
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02573324      |      Link to official Clinicaltrials.gov listing
Locations
Buenos Aires,
Argentina

Facility: Instituto Med Alex Flem
Investigator:
Contact:
Email not avaialable

Liverpool, New South Wales
Australia

Facility: Liverpool Hospital
Investigator:
Contact:
Email not avaialable

Randwick, New South Wales
Australia

Facility: The Prince of Wales Hospital
Investigator:
Contact:
Email not avaialable

Saint Leonards, New South Wales
Australia

Facility: Royal North Shore Hospital
Investigator:
Contact:
Email not avaialable

Waratah, New South Wales
Australia

Facility: Calvary Mater Newcastle
Investigator:
Contact:
Email not avaialable

Wollongong, New South Wales
Australia

Facility: Southern Medical Day Care Ctr
Investigator:
Contact:
Email not avaialable

Woolloongabba, Queensland
Australia

Facility: Princess Alexandra Hospital
Investigator:
Contact:
Email not avaialable

Adelaide, South Australia
Australia

Facility: Royal Adelaide Hospital
Investigator:
Contact:
Email not avaialable

Adelaide, South Australia
Australia

Facility: Calvary North Adelaide Hospita
Investigator:
Contact:
Email not avaialable

Fitzroy, Victoria
Australia

Facility: St. Vincents Hosp Melbourne
Investigator:
Contact:
Email not avaialable

Heidelberg, Victoria
Australia

Facility: Austin Hospital
Investigator:
Contact:
Email not avaialable

Subiaco, Western Australia
Australia

Facility: St. John of God Subiaco Hosp
Investigator:
Contact:
Email not avaialable

Graz,
Austria

Facility: LKH-Univ. Klinikum Graz
Investigator:
Contact:
Email not avaialable

Innsbruck,
Austria

Facility: Medical University Innsbruck
Investigator:
Contact:
Email not avaialable

Linz,
Austria

Facility: Kepler Universitatskliniken
Investigator:
Contact:
Email not avaialable

Vienna,
Austria

Facility: Medical University of Vienna
Investigator:
Contact:
Email not avaialable

Brussels,
Belgium

Facility: Cliniques Univ. Saint Luc
Investigator:
Contact:
Email not avaialable

Charleroi,
Belgium

Facility: Grand Hopital de Charleroi
Investigator:
Contact:
Email not avaialable

Ghent,
Belgium

Facility: UZ Ghent
Investigator:
Contact:
Email not avaialable

Leuven,
Belgium

Facility: UZ Leuven
Investigator:
Contact:
Email not avaialable

Yvoir,
Belgium

Facility: UCL Mont Godinne
Investigator:
Contact:
Email not avaialable

Liège, Liege
Belgium

Facility: CHU Liège Sart Tilman
Investigator:
Contact:
Email not avaialable

Rio de Janeiro,
Brazil

Facility: INCA
Investigator:
Contact:
Email not avaialable

Sao Paulo,
Brazil

Facility: ICESP
Investigator:
Contact:
Email not avaialable

Sao Paulo,
Brazil

Facility: Hospital de Cancer de Barretos
Investigator:
Contact:
Email not avaialable

Natal, Rio Grande Do Norte
Brazil

Facility: Liga Norte Rigrandese Contra o
Investigator:
Contact:
Email not avaialable

Porto Alegre, Rio Grande Do Sul
Brazil

Facility: Hospital Sao Lucas da PUCRS
Investigator:
Contact:
Email not avaialable

Winnipeg, Manitoba
Canada

Facility: Cancer Care Manitoba
Investigator:
Contact:
Email not avaialable

Halifax, Nova Scotia
Canada

Facility: Qe Ii Hsc
Investigator:
Contact:
Email not avaialable

Hamilton, Ontario
Canada

Facility: Juravinski Cancer Clinic
Investigator:
Contact:
Email not avaialable

London, Ontario
Canada

Facility: Victoria Hospital
Investigator:
Contact:
Email not avaialable

Ottawa, Ontario
Canada

Facility: The Ottawa Hospital
Investigator:
Contact:
Email not avaialable

Toronto, Ontario
Canada

Facility: Princess Margaret Cancer Centr
Investigator:
Contact:
Email not avaialable

Montreal, Quebec
Canada

Facility: Hospital Maisonneuve-Rosemont
Investigator:
Contact:
Email not avaialable

Montreal, Quebec
Canada

Facility: CHUM - Notre-Dame Hospital
Investigator:
Contact:
Email not avaialable

Montreal, Quebec
Canada

Facility: McGill Univ HC
Investigator:
Contact:
Email not avaialable

Montreal, Quebec
Canada

Facility: Jewish General Hospital
Investigator:
Contact:
Email not avaialable

Quebec City, Quebec
Canada

Facility: CHU de Quebec-Universite Laval
Investigator:
Contact:
Email not avaialable

Sherbrooke, Quebec
Canada

Facility: CRC-CHUS
Investigator:
Contact:
Email not avaialable

Xi'an,
China

Facility: Fourth Military Medical Univ.
Investigator:
Contact:
Email not avaialable

Shanghai, Shanghai
China

Facility: Huashan Hospital of Fudan Univ
Investigator:
Contact:
Email not avaialable

Cali,
Colombia

Facility: Centro Medico Imbanaco de Cali
Investigator:
Contact:
Email not avaialable

Medellín,
Colombia

Facility: Hospital Pablo Tobon Uribe
Investigator:
Contact:
Email not avaialable

Monteria,
Colombia

Facility: Inst Med Alta Tec Onc (IMAT)
Investigator:
Contact:
Email not avaialable

Pereira,
Colombia

Facility: Oncologos de Occidente SA
Investigator:
Contact:
Email not avaialable

Bogota, Cundinamarca
Colombia

Facility: Administradora de Country S.A_Clinica del Country
Investigator:
Contact:
Email not avaialable

Liberec,
Czechia

Facility: Krajska nemocnice Liberec a.s.
Investigator:
Contact:
Email not avaialable

Angers,
France

Facility: Insititut de Cancerologie
Investigator:
Contact:
Email not avaialable

Nice,
France

Facility: CHU de Nice
Investigator:
Contact:
Email not avaialable

Paris,
France

Facility: Hopital Pitie Salpetriere
Investigator:
Contact:
Email not avaialable

Villejuif, Ile-de-France
France

Facility: Institut Gustave Roussy
Investigator:
Contact:
Email not avaialable

St Herblain CEDEX, Loire-Atlantique
France

Facility: Institut de Cancer de l'Ouest
Investigator:
Contact:
Email not avaialable

Lille CEDEX, Nord-Pas-de-Calais
France

Facility: CHRU de Lille, Hopital Roger Salengro
Investigator:
Contact:
Email not avaialable

Marseille CEDEX 05, Provence-Alpes-Cote-d Azur
France

Facility: Hopital de la Timone
Investigator:
Contact:
Email not avaialable

Bochum,
Germany

Facility: Knappschaftskrankenhaus
Investigator:
Contact:
Email not avaialable

Heidelberg,
Germany

Facility: Universitaetsklinik Heidelberg
Investigator:
Contact:
Email not avaialable

Tuebingen,
Germany

Facility: Universitatsklinikum Tubingen
Investigator:
Contact:
Email not avaialable

Leipzig, Sachsen
Germany

Facility: Universitaetsklinikum Leipzig
Investigator:
Contact:
Email not avaialable

Hong Kong,
Hong Kong

Facility: Prince of Wales Hospital
Investigator:
Contact:
Email not avaialable

Dublin,
Ireland

Facility: Beaumont Hospital
Investigator:
Contact:
Email not avaialable

Haifa,
Israel

Facility: Rambam Health Care Campus
Investigator:
Contact:
Email not avaialable

Jerusalem,
Israel

Facility: Hadassah University Hospital
Investigator:
Contact:
Email not avaialable

Petah Tikva,
Israel

Facility: Rabin Medical Center
Investigator:
Contact:
Email not avaialable

Ramat Gan,
Israel

Facility: Sheba Medical Center
Investigator:
Contact:
Email not avaialable

Tel Aviv,
Israel

Facility: Tel Aviv Sourasky Medical Ctr
Investigator:
Contact:
Email not avaialable

Milan,
Italy

Facility: Fondazione IRCCS Istituto Neur
Investigator:
Contact:
Email not avaialable

Padua,
Italy

Facility: Istituto Oncologico Veneto
Investigator:
Contact:
Email not avaialable

Rome,
Italy

Facility: Regina Elena National Cancer I
Investigator:
Contact:
Email not avaialable

Torino,
Italy

Facility: AOU Citta della Salute Scienza
Investigator:
Contact:
Email not avaialable

Seoul,
Korea, Republic of

Facility: Cath Univ Seoul St Mary's Hosp
Investigator:
Contact:
Email not avaialable

Seoul,
Korea, Republic of

Facility: Samsung Medical Center
Investigator:
Contact:
Email not avaialable

Goyang, Gyeonggido
Korea, Republic of

Facility: National Cancer Center
Investigator:
Contact:
Email not avaialable

Seoul, Seoul Teugbyeolsi
Korea, Republic of

Facility: Seoul National University Hospital
Investigator:
Contact:
Email not avaialable

Seoul, Seoul Teugbyeolsi
Korea, Republic of

Facility: Severance Hospital
Investigator:
Contact:
Email not avaialable

San Pedro Garza García,
Mexico

Facility: Hospital Zambrano Hellion
Investigator:
Contact:
Email not avaialable

Amsterdam,
Netherlands

Facility: Vrije Univ Medisch Centrum
Investigator:
Contact:
Email not avaialable

Groningen,
Netherlands

Facility: Univ Med Center Groningen
Investigator:
Contact:
Email not avaialable

Maastricht,
Netherlands

Facility: Maastricht University Med Ctr
Investigator:
Contact:
Email not avaialable

The Hague,
Netherlands

Facility: MC Haaglanden - Westeinde
Investigator:
Contact:
Email not avaialable

Utrecht,
Netherlands

Facility: UMC Utrecht
Investigator:
Contact:
Email not avaialable

Christchurch,
New Zealand

Facility: Canterbury District Health Boa
Investigator:
Contact:
Email not avaialable

Wellington,
New Zealand

Facility: Wellington Hospital
Investigator:
Contact:
Email not avaialable

Braga,
Portugal

Facility: Hospital of Braga
Investigator:
Contact:
Email not avaialable

Faro,
Portugal

Facility: Centro Hospitalar do Algarve
Investigator:
Contact:
Email not avaialable

Lisboa,
Portugal

Facility: IPO Lisboa FG, EPE
Investigator:
Contact:
Email not avaialable

Lisboa,
Portugal

Facility: Centro Hospitalar Lisboa Norte, EPE
Investigator:
Contact:
Email not avaialable

Porto,
Portugal

Facility: Centro Hospitalar de Sao Joao, EPE
Investigator:
Contact:
Email not avaialable

Moscow,
Russian Federation

Facility: Moscow Reg Res Clin Inst
Investigator:
Contact:
Email not avaialable

UFA, Kirovskaya Oblast
Russian Federation

Facility: State budgetary healthcare institution Republican Clinical Oncology Dispensary
Investigator:
Contact:
Email not avaialable

Moscow, Moskva
Russian Federation

Facility: Russian N.N.Blokhin Cancer Research Center
Investigator:
Contact:
Email not avaialable

Moscow, Moskva
Russian Federation

Facility: Federal State Autonomic Institution "Scientific and Research institute of neur
Investigator:
Contact:
Email not avaialable

Ekaterinburg, Sverdlovskaya Oblast
Russian Federation

Facility: Sverdlovsk Regional Oncology Center
Investigator:
Contact:
Email not avaialable

Singapore,
Singapore

Facility: National University Hospital
Investigator:
Contact:
Email not avaialable

Singapore,
Singapore

Facility: National Cancer Ctr Singapore
Investigator:
Contact:
Email not avaialable

Bloemfontein, Free State
South Africa

Facility: Universitas Annexe
Investigator:
Contact:
Email not avaialable

Durban, Kwazulu-Natal
South Africa

Facility: The Oncology Centre
Investigator:
Contact:
Email not avaialable

Cape Town, Western Cape
South Africa

Facility: Netcare Oncology Intervent Ctr
Investigator:
Contact:
Email not avaialable

Cape Town, Western Cape
South Africa

Facility: Cape Town Oncology Trials
Investigator:
Contact:
Email not avaialable

Cape Town, Western Cape
South Africa

Facility: GVI Rondebosch Oncology Centre
Investigator:
Contact:
Email not avaialable

Barcelona,
Spain

Facility: Hosp Santa Creu i Sant Pau
Investigator:
Contact:
Email not avaialable

Barcelona,
Spain

Facility: Hospital de Barcelona
Investigator:
Contact:
Email not avaialable

Madrid,
Spain

Facility: Hospital Clin Univ San Carlos
Investigator:
Contact:
Email not avaialable

Madrid,
Spain

Facility: Hosp Univ 12 de Octubre
Investigator:
Contact:
Email not avaialable

Madrid,
Spain

Facility: Hosp Univ Madrid Sanchinarro
Investigator:
Contact:
Email not avaialable

Malaga,
Spain

Facility: Hospital Reg Uni de Malaga
Investigator:
Contact:
Email not avaialable

Valencia,
Spain

Facility: Hosp General Univ de Valencia
Investigator:
Contact:
Email not avaialable

Aarau,
Switzerland

Facility: Kantonsspital Aarau
Investigator:
Contact:
Email not avaialable

Bellinzona,
Switzerland

Facility: Ente Ospedaliero Cantonale
Investigator:
Contact:
Email not avaialable

Bern,
Switzerland

Facility: Inselspital, Universitaetsklin
Investigator:
Contact:
Email not avaialable

Zurich,
Switzerland

Facility: University Hospital Zurich
Investigator:
Contact:
Email not avaialable

Taipei City,
Taiwan

Facility: National Taiwan Univ Hosp
Investigator:
Contact:
Email not avaialable

Taipei City,
Taiwan

Facility: Taipei Veterans General Hosp
Investigator:
Contact:
Email not avaialable

Taoyuan City,
Taiwan

Facility: Linkou Chang Gung Memorial Ho
Investigator:
Contact:
Email not avaialable

Birmingham,
United Kingdom

Facility: Univ Hospitals Birmingham NHS
Investigator:
Contact:
Email not avaialable

Cardiff,
United Kingdom

Facility: Velindre Cancer Centre
Investigator:
Contact:
Email not avaialable

Dundee,
United Kingdom

Facility: Ninewells Hospital
Investigator:
Contact:
Email not avaialable

Edinburgh,
United Kingdom

Facility: Western General Hospital
Investigator:
Contact:
Email not avaialable

Leeds,
United Kingdom

Facility: St. James University Hospital
Investigator:
Contact:
Email not avaialable

London,
United Kingdom

Facility: University College Hospitals
Investigator:
Contact:
Email not avaialable

London,
United Kingdom

Facility: Guy's and St Thomas' NHS Found
Investigator:
Contact:
Email not avaialable

Newcastle Upon Tyne,
United Kingdom

Facility: Freeman Hospital
Investigator:
Contact:
Email not avaialable

Sutton,
United Kingdom

Facility: Royal Marsden Hospital
Investigator:
Contact:
Email not avaialable

Phoenix, Arizona
Facility: St. Josephs Hosp and Med Ctr
Investigator:
Contact:
Email not avaialable

Fayetteville, Arkansas
Facility: Highlands Oncology Group
Investigator:
Contact:
Email not avaialable

Los Angeles, California
Facility: USC
Investigator:
Contact:
Email not avaialable

Los Angeles, California
Facility: Cedars-Sinai Medical Ctr
Investigator:
Contact:
Email not avaialable

Los Angeles, California
Facility: UCLA
Investigator:
Contact:
Email not avaialable

San Diego, California
Facility: Sharp Memorial Hospital
Investigator:
Contact:
Email not avaialable

San Francisco, California
Facility: Univ California, San Francisco
Investigator:
Contact:
Email not avaialable

Santa Monica, California
Facility: St. John's Health Center
Investigator:
Contact:
Email not avaialable

Aurora, Colorado
Facility: Children's Hospital Colorado
Investigator:
Contact:
Email not avaialable

Fairfield, Connecticut
Facility: Associated Neurologists of Sou
Investigator:
Contact:
Email not avaialable

New Haven, Connecticut
Facility: Yale University
Investigator:
Contact:
Email not avaialable

Newark, Delaware
Facility: Christiana Care Health Service
Investigator:
Contact:
Email not avaialable

Miami, Florida
Facility: Baptist Hospital Miami
Investigator:
Contact:
Email not avaialable

Orlando, Florida
Facility: Florida Hospital
Investigator:
Contact:
Email not avaialable

Tampa, Florida
Facility: Moffitt Cancer Center
Investigator:
Contact:
Email not avaialable

Atlanta, Georgia
Facility: Piedmont Hospital
Investigator:
Contact:
Email not avaialable

Atlanta, Georgia
Facility: Emory University Hospital
Investigator:
Contact:
Email not avaialable

Chicago, Illinois
Facility: Northwestern University
Investigator:
Contact:
Email not avaialable

Chicago, Illinois
Facility: University of Chicago
Investigator:
Contact:
Email not avaialable

Evanston, Illinois
Facility: NorthShore Univ HealthSystem
Investigator:
Contact:
Email not avaialable

Warrenville, Illinois
Facility: NW Medical Cancer Ctr, Warrenv
Investigator:
Contact:
Email not avaialable

Fort Wayne, Indiana
Facility: Parkview Research Ctr, Hosp
Investigator:
Contact:
Email not avaialable

Westwood, Kansas
Facility: Univ Kansas Cancer Ctr - Overl
Investigator:
Contact:
Email not avaialable

Scarborough, Maine
Facility: Maine Medical Partners Neurolo
Investigator:
Contact:
Email not avaialable

Boston, Massachusetts
Facility: Tufts Medical Center
Investigator:
Contact:
Email not avaialable

Boston, Massachusetts
Facility: Massachusetts General Hospital
Investigator:
Contact:
Email not avaialable

Detroit, Michigan
Facility: Henry Ford Health System
Investigator:
Contact:
Email not avaialable

Detroit, Michigan
Facility: Wayne State University
Investigator:
Contact:
Email not avaialable

Ypsilanti, Michigan
Facility: St. Joseph Mercy Hospital
Investigator:
Contact:
Email not avaialable

Saint Louis Park, Minnesota
Facility: MMCORC
Investigator:
Contact:
Email not avaialable

Saint Louis, Missouri
Facility: Washington Univ School Med
Investigator:
Contact:
Email not avaialable

Omaha, Nebraska
Facility: Nebraska Methodist Hospital
Investigator:
Contact:
Email not avaialable

Omaha, Nebraska
Facility: Univ Nebraska Med Ctr
Investigator:
Contact:
Email not avaialable

New Brunswick, New Jersey
Facility: Rutgers Cancer Institute of NJ
Investigator:
Contact:
Email not avaialable

Voorhees, New Jersey
Facility: Cooper Health System
Investigator:
Contact:
Email not avaialable

New York, New York
Facility: Columbia University Medical Center-OB/GYN Department
Investigator:
Contact:
Email not avaialable

Rochester, New York
Facility: Univ Rochester Med Ctr
Investigator:
Contact:
Email not avaialable

Charlotte, North Carolina
Facility: Levine Cancer Ins, Carolina Me
Investigator:
Contact:
Email not avaialable

Cincinnati, Ohio
Facility: University of Cincinnati
Investigator:
Contact:
Email not avaialable

Cleveland, Ohio
Facility: Univ Hosp Cleveland
Investigator:
Contact:
Email not avaialable

Cleveland, Ohio
Facility: Cleveland Clinic Foundation
Investigator:
Contact:
Email not avaialable

Columbus, Ohio
Facility: The Ohio State University
Investigator:
Contact:
Email not avaialable

Toledo, Ohio
Facility: University of Toledo
Investigator:
Contact:
Email not avaialable

Oklahoma City, Oklahoma
Facility: Univ Oklahoma HSC
Investigator:
Contact:
Email not avaialable

Bethlehem, Pennsylvania
Facility: St. Luke's Hospital
Investigator:
Contact:
Email not avaialable

Hershey, Pennsylvania
Facility: Penn State University and Milton S. Hershey Medical Center
Investigator:
Contact:
Email not avaialable

Philadelphia, Pennsylvania
Facility: University of Pennsylvania
Investigator:
Contact:
Email not avaialable

Philadelphia, Pennsylvania
Facility: Thomas Jefferson Obsterics and Gynecology
Investigator:
Contact:
Email not avaialable

Philadelphia, Pennsylvania
Facility: Fox Chase Cancer Center
Investigator:
Contact:
Email not avaialable

Pittsburgh, Pennsylvania
Facility: Allegheny General Hospital
Investigator:
Contact:
Email not avaialable

Pittsburgh, Pennsylvania
Facility: UPMC - Shadyside Radiation Onc
Investigator:
Contact:
Email not avaialable

Charleston, South Carolina
Facility: Med Univ of South Carolina
Investigator:
Contact:
Email not avaialable

Austin, Texas
Facility: Austin Cancer Centers
Investigator:
Contact:
Email not avaialable

Dallas, Texas
Facility: Baylor Sammons Cancer Center
Investigator:
Contact:
Email not avaialable

Houston, Texas
Facility: Univ TX, MD Anderson
Investigator:
Contact:
Email not avaialable

Temple, Texas
Facility: Scott and White Medical Center
Investigator:
Contact:
Email not avaialable

Murray, Utah
Facility: Intermountain Medical Center
Investigator:
Contact:
Email not avaialable

Salt Lake City, Utah
Facility: University of Utah
Investigator:
Contact:
Email not avaialable

Richmond, Virginia
Facility: Virginia Commonwealth Univ
Investigator:
Contact:
Email not avaialable

Seattle, Washington
Facility: Virginia Mason Medical Center
Investigator:
Contact:
Email not avaialable

Seattle, Washington
Facility: University of Washington
Investigator:
Contact:
Email not avaialable

Madison, Wisconsin
Facility: Univ of Wisconsin Hosp/Clinics
Investigator:
Contact:
Email not avaialable

Milwaukee, Wisconsin
Facility: Froedtert and Medical College
Investigator:
Contact:
Email not avaialable




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