Clinical trial NCT02573324: A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification
Official title: A Randomized, Placebo Controlled Phase 3 Study of ABT-414 With Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glioblastoma
Gliosarcoma
Keywords: Newly Diagnosed Glioblastoma
Epithelial Growth Factor Receptor (EGFR)
Temozolomide
ABT-414
Radiology Therapy Oncology Group
Antibody Drug Conjugate
Brain Tumor
Brain Tumor Group
EGFRvIII
EGFR Amplified
First Line Therapy
Brain Cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Radiation Therapy Oncology Group
First posted: 2015-10-09
Enrollment: 691
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) followed by combination of ABT-414 with adjuvant TMZ prolongs overall survival (OS) among participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification.

In addition, there is a Phase 1, open-label, multicenter sub-study to assess the pharmacokinetics, safety and tolerability of ABT-414 in participants with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.


Eligibility criteria: Inclusion Criteria:

* Must have a clinical diagnosis of glioblastoma (GBM).
* Must have a confirmed epidermal growth factor receptor amplification in tumor tissue.
* Must have a Karnofsky Performance Status (KPS) \>= 70 at assessment \<= 14 days prior to randomization (N/A to the sub-study).
* Must have recovered from effects of surgery, postoperative infection and other complications of surgery.
* Must have adequate bone marrow, renal, and hepatic function (For the sub-study, the participant must have adequate bone marrow and renal function and have mild-to-moderate hepatic impairment).

Exclusion Criteria:

* Multifocal, recurrent or metastatic GBM or gliomatosis cerebri (For the sub-study, the participant can have multifocal GBM and glimatosis cerebri but can't have recurrent or metastatic GBM).
* Prior chemo therapy or radiosensitizer for head and neck cancer.
* Prior radiotherapy to the head or neck in overlap of radiation fields.
* Prior therapy for glioblastoma or other invasive malignancy.
* Prior, concomitant or planned treatment with Novo Tumor Treatment Fields (Novo-TTF), EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic therapy.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary outcomes:
measure: OS for the O6-methylguaninemethlytransferese (MGMT) Unmethylated Group
timeFrame: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
measure: OS for the MGMT Methylated Group
timeFrame: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
measure: OS for the Epidermal Growth Factor Receptor (EGFR)vIII-Mutated Tumor Subgroup
timeFrame: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
measure: Progression-Free Survival (PFS)
timeFrame: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
measure: PFS for EGFRvIII-Mutated Tumor Subgroup
timeFrame: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
measure: Deterioration Free Survival in M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) Symptom Severity Score
timeFrame: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
measure: Deterioration Free Survival in MDASI-BT Symptom Interference Score
timeFrame: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
measure: Deterioration Free Survival in Neurocognitive Functioning on the Hopkins Verbal Learning Test Revised (HVLT-R) Total Recall Score
timeFrame: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Josephs Hospital and Med Center /ID# 144149
state: Arizona
city: Springdale
country: United States
facility: Highlands Oncology Group, PA /ID# 142050
state: Arkansas
city: Los Angeles
country: United States
facility: University of Southern California /ID# 147543
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles /ID# 149239
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital /ID# 148193
state: California
city: San Francisco
country: United States
facility: Univ California, San Francisco /ID# 145889
state: California
city: Santa Monica
country: United States
facility: Duplicate_St. John's Health Center /ID# 148192
state: California
city: West Hollywood
country: United States
facility: Cedars-Sinai Medical Center-West Hollywood /ID# 148472
state: California
city: Aurora
country: United States
facility: Univ of Colorado Cancer Center /ID# 148194
state: Colorado
city: Fairfield
country: United States
facility: Associated Neurologists of Sou /ID# 147701
state: Connecticut
city: New Haven
country: United States
facility: Yale University /ID# 144170
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Health Service /ID# 144127
state: Delaware
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital /ID# 163659
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital /ID# 156764
state: Florida
city: Miami
country: United States
facility: Baptist Hospital Miami /ID# 152451
state: Florida
city: Orlando
country: United States
facility: Advent Health /ID# 144128
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center /ID# 144130
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital /ID# 145892
state: Georgia
city: Atlanta
country: United States
facility: Emory Midtown Infectious Disease Clinic /ID# 144015
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine /ID# 147895
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medical Center /ID# 144158
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem /ID# 144017
state: Illinois
city: Warrenville
country: United States
facility: Northwestern Medicine Cancer Center - Warrenville /ID# 148476
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Research Ctr, Hosp /ID# 144150
state: Indiana
city: Westwood
country: United States
facility: Univ Kansas Cancer Ctr - Overl /ID# 145895
state: Kansas
city: Scarborough
country: United States
facility: Maine Medical Partners Neurolo /ID# 160864
state: Maine
city: Boston
country: United States
facility: Tufts Medical Center /ID# 145897
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital /ID# 144145
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute /ID# 148475
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University /ID# 145890
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System /ID# 145896
state: Michigan
city: Ypsilanti
country: United States
facility: Duplicate_St. Joseph Mercy Hospital /ID# 144143
state: Michigan
city: Saint Louis Park
country: United States
facility: Mmcorc /Id# 144146
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 144174
state: Missouri
city: Omaha
country: United States
facility: Nebraska Methodist Hospital /ID# 144140
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center /ID# 145899
state: Nebraska
city: Camden
country: United States
facility: MD Anderson Cancer Center at Cooper - Camden /ID# 145891
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey /ID# 148190
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center /ID# 144020
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center /ID# 144166
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Ins, Carolina Me /ID# 144124
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati /ID# 144164
state: Ohio
city: Cleveland
country: United States
facility: Duplicate_Univ Hosp Cleveland /ID# 144153
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus /ID# 144023
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University /ID# 144016
state: Ohio
city: Toledo
country: United States
facility: University of Toledo /ID# 156763
state: Ohio
city: Oklahoma City
country: United States
facility: Univ Oklahoma HSC /ID# 144161
state: Oklahoma
city: Bethlehem
country: United States
facility: St. Luke's Hospital /ID# 148191
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State University and Milton S. Hershey Medical Center /ID# 147525
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania /ID# 157623
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University /ID# 144191
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center /ID# 145893
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital /ID# 144126
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pennsylvania Medical Center - Shadyside /ID# 144159
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina /ID# 144141
state: South Carolina
city: Austin
country: United States
facility: Austin Cancer Centers /ID# 151061
state: Texas
city: Dallas
country: United States
facility: Baylor Sammons Cancer Center /ID# 155542
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston /ID# 144013
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center /ID# 144018
state: Texas
city: Temple
country: United States
facility: Duplicate_Scott and White Medical Center /ID# 160743
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center /ID# 144142
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah /ID# 144160
state: Utah
city: Falls Church
country: United States
facility: Inova Health System /ID# 152956
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center Main Hospital /ID# 149014
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center /ID# 144022
state: Washington
city: Seattle
country: United States
facility: University of Washington /ID# 144162
state: Washington
city: Madison
country: United States
facility: Univ of Wisconsin Hosp/Clinics /ID# 144167
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert Memorial Lutheran Hospital /ID# 144139
state: Wisconsin
city: Rosario
country: Argentina
facility: Sanatorio Parque /ID# 142825
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Duplicate_Instituto Med Alex Flem /ID# 142884
city: Liverpool
country: Australia
facility: Liverpool Hospital /ID# 144392
state: New South Wales
city: Randwick
country: Australia
facility: Duplicate_The Prince of Wales Hospital /ID# 144882
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital /ID# 143870
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle /ID# 143860
state: New South Wales
city: Wollongong
country: Australia
facility: Southern Medical Day Care Centre /ID# 143868
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital /ID# 143857
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital /ID# 143867
state: South Australia
city: Adelaide
country: Australia
facility: Calvary North Adelaide Hospita /ID# 143866
state: South Australia
city: Fitzroy Melbourne
country: Australia
facility: St Vincent's Hospital Melbourne /ID# 143858
state: Victoria
city: Heidelberg
country: Australia
facility: Duplicate_Austin Hospital /ID# 143859
state: Victoria
city: Subiaco
country: Australia
facility: St John Of God Subiaco Hospital /ID# 143869
state: Western Australia
city: Graz
country: Austria
facility: Medizinische Universitaet Graz /ID# 141982
state: Steiermark
city: Vienna
country: Austria
facility: Medizinische Universitaet Wien /ID# 141981
state: Wien
city: Innsbruck
country: Austria
facility: Duplicate_Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Mediz /ID# 141984
city: Linz
country: Austria
facility: Kepler Universitätsklinikum GmbH - Neuromed Campus /ID# 141983
city: Woluwe-Saint-Lambert
country: Belgium
facility: UCL Saint-Luc /ID# 141648
state: Bruxelles-Capitale
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi /ID# 141645
state: Hainaut
city: Gent
country: Belgium
facility: UZ Gent /ID# 141647
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven /ID# 143872
state: Vlaams-Brabant
city: La Louvière
country: Belgium
facility: Duplicate_Centre Hospitalier Jolimont /ID# 143873
city: Liege
country: Belgium
facility: CHU de Liege /ID# 162860
city: Yvoir
country: Belgium
facility: Duplicate_UCL Mont Godinne /ID# 141644
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Câncer /ID# 143878
state: Rio Grande Do Norte
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS /ID# 143879
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 143876
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Instituto do Câncer do Estado de São Paulo - ICESP /ID# 144031
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 143877
city: Winnipeg
country: Canada
facility: Duplicate_Cancer Care Manitoba /ID# 149253
state: Manitoba
city: Halifax
country: Canada
facility: QE II Health Sciences Centre /ID# 151600
state: Nova Scotia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre /ID# 152117
state: Ontario
city: London
country: Canada
facility: Victoria Hospital /ID# 144184
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute /ID# 150120
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre /ID# 166277
state: Ontario
city: Montreal
country: Canada
facility: Duplicate_Hospital Maisonneuve-Rosemont /ID# 149315
state: Quebec
city: Montreal
country: Canada
facility: Duplicate_Jewish General Hospital /ID# 144029
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital / McGill University Health Centre /ID# 144187
state: Quebec
city: Montréal
country: Canada
facility: CHUM - Notre-Dame Hospital /ID# 144027
state: Quebec
city: Quebec City
country: Canada
facility: CHU de Quebec-Universite Laval /ID# 144189
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS - Hopital Fleurimont /ID# 149771
state: Quebec
city: Hefei
country: China
facility: Anhui Provincial Hospital /ID# 166320
state: Anhui
city: Beijing
country: China
facility: SanboBrain Hospital Capital Medical University /ID# 166422
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital /ID# 157430
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center /ID# 143919
state: Guangdong
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College of HUST /ID# 163820
state: Hubei
city: Changsha
country: China
facility: Duplicate_Xiangya Hospital Central South University /ID# 166791
state: Hunan
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University /ID# 165596
state: Jiangsu
city: Xi'an
country: China
facility: Duplicate_Tangdu Hospital /ID# 143920
state: Shaanxi
city: Shanghai
country: China
facility: Duplicate_Huashan Hospital of Fudan University /ID# 159999
state: Shanghai
city: Hangzhou
country: China
facility: Duplicate_The Second Affiliated Hospital of ZUSM /ID# 165593
state: Zhejiang
city: Beijing
country: China
facility: Beijing Tian Tan Hospital, Capital Medical University /ID# 167160
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University /ID# 159166
city: Shenyang
country: China
facility: Duplicate_Shengjing Hospital of China Medical University /ID# 167016
city: Tianjin
country: China
facility: Duplicate_Tianjin Med Univ General Hosp /ID# 143923
city: Medellín
country: Colombia
facility: Hospital Pablo Tobon Uribe /ID# 143780
state: Antioquia
city: Monteria
country: Colombia
facility: Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 147223
state: Cordoba
city: Bogota
country: Colombia
facility: Administradora del Country_S.A-Clinica Del Country /ID# 143881
state: Cundinamarca
city: Pereira
country: Colombia
facility: Oncologos del Occidente S.A /ID# 147713
state: Risaralda
city: Cali
country: Colombia
facility: Centro Medico Imbanaco de Cali /ID# 143882
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav /ID# 143884
city: Hradec Kralove
country: Czechia
facility: Duplicate_FN Hradec Kralove /ID# 143885
city: Liberec
country: Czechia
facility: Krajska nemocnice Liberec, a.s. /ID# 142024
city: Ostrava
country: Czechia
facility: Duplicate_Univ Hosp Ostrava-Poruba /ID# 143883
city: Praha
country: Czechia
facility: Fakultni Nemocnice v Motole /ID# 142023
city: Marseille CEDEX 05
country: France
facility: AP-HM - Hopital de la Timone /ID# 143911
state: Bouches-du-Rhone
city: Lille
country: France
facility: CHRU Lille - Hopital Claude Huriez /ID# 143915
state: Hauts-de-France
city: Bobigny
country: France
facility: Hopital Avicenne - APHP /ID# 143910
state: Ile-de-France
city: Villejuif Cedex
country: France
facility: Duplicate_Gustave Roussy /ID# 143912
state: Ile-de-France
city: St Herblain CEDEX
country: France
facility: Institut de Cancérologie de l'Ouest René Gauducheau /ID# 143914
state: Loire-Atlantique
city: Nice CEDEX 1
country: France
facility: CHU Nice -Hopital Pasteur /ID# 143916
state: Provence-Alpes-Cote-d Azur
city: Angers
country: France
facility: Insititut de Cancerologie /ID# 143908
city: Paris
country: France
facility: Hopital Pitie Salpetriere /ID# 143917
city: Heidelberg
country: Germany
facility: Universitaetsklinik Heidelberg /ID# 143927
state: Baden-Wuerttemberg
city: Tubingen
country: Germany
facility: Universitaetsklinikum Tuebingen /ID# 143926
state: Baden-Wuerttemberg
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig /ID# 143962
state: Sachsen
city: Bochum
country: Germany
facility: Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH /ID# 143961
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital /ID# 143952
city: Beaumont
country: Ireland
facility: Beaumont Hospital /ID# 142969
state: Dublin
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 143960
state: Tel-Aviv
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 143956
state: Tel-Aviv
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 143959
city: Jerusalem
country: Israel
facility: Gastroenterology Institute, Division of Medicine /ID# 143958
city: Petakh Tikva
country: Israel
facility: Rabin Medical Center /ID# 143957
city: Turin
country: Italy
facility: Duplicate_Duplicate_AOU Citta della Salute Scienza /ID# 141801
state: Piemonte
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 141800
city: Padova
country: Italy
facility: Istituto Oncologico Veneto /ID# 143821
city: Rome
country: Italy
facility: Duplicate_Regina Elena National Cancer I /ID# 141795
city: Goyang
country: Korea, Republic of
facility: National Cancer Center /ID# 141845
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Duplicate_Yonsei University Health System, Severance hospital. /ID# 141846
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 143886
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 143887
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 141844
city: San Pedro Garza Garcia
country: Mexico
facility: Centro Medico Zambrano Hellion /ID# 143845
state: Nuevo Leon
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum /ID# 143889
city: Den Haag
country: Netherlands
facility: Haaglanden Medisch Centrum /ID# 141405
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen /ID# 141408
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum /ID# 143585
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht /ID# 141406
city: Christchurch
country: New Zealand
facility: Duplicate_Canterbury District Health Boa /ID# 143861
city: Wellington
country: New Zealand
facility: Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 143890
city: Braga
country: Portugal
facility: CCA Braga - Hospital de Braga /ID# 141940
city: Faro
country: Portugal
facility: Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 141939
city: Lisboa
country: Portugal
facility: IPO Lisboa FG, EPE /ID# 141938
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 141941
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 142830
city: Kaliningrad
country: Russian Federation
facility: Regional Clinical Hospital of Kaliningrad region /ID# 141702
state: Kaliningradskaya Oblast
city: Ufa
country: Russian Federation
facility: State budgetary healthcare institution Republican Clinical Oncology Dispensary /ID# 141706
state: Kirovskaya Oblast
city: Moscow
country: Russian Federation
facility: GEMC - European Medical Center /ID# 141703
state: Moskovskaya Oblast
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 141707
state: Moskva
city: Moscow
country: Russian Federation
facility: National Medical Research Center for Neurosurgery n.a. N. N. Burdenko /ID# 141701
state: Moskva
city: Moscow
country: Russian Federation
facility: Federal State Treatment and Rehabilitation center /ID# 141704
state: Moskva
city: Yekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Oncology Dispensary /ID# 141700
state: Sverdlovskaya Oblast
city: Singapore
country: Singapore
facility: National University Hospital /ID# 143933
city: Singapore
country: Singapore
facility: National Cancer Ctr Singapore /ID# 143932
city: Bloemfontein
country: South Africa
facility: University of Free State, Universitas Annex (National Hospital Grounds) /ID# 144064
state: Free State
city: Centurion
country: South Africa
facility: Netcare Unitas Hospital /ID# 152936
state: Gauteng
city: Durban
country: South Africa
facility: The Oncology Centre /ID# 143950
state: Kwazulu-Natal
city: Cape Town
country: South Africa
facility: Netcare Oncology Intervent Ctr /ID# 143951
state: Western Cape
city: Cape Town
country: South Africa
facility: Rondebosch Oncology Center /ID# 143949
state: Western Cape
city: Kraaifontein
country: South Africa
facility: Cape Town Oncology Trials /ID# 143948
state: Western Cape
city: Málaga
country: Spain
facility: Hospital Regional de Malaga /ID# 143902
state: Malaga
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona /ID# 143906
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau /ID# 143900
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos /ID# 143901
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 143930
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro /ID# 143496
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia /ID# 143903
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau AG /ID# 141885
state: Aargau
city: Zurich
country: Switzerland
facility: Universitatsspital Zurich /ID# 141887
state: Zuerich
city: Bellinzona
country: Switzerland
facility: Duplicate_EOC Ospedale Regionale di Bellinzona e Valli /ID# 143936
city: Bern
country: Switzerland
facility: Inselspital, Universitätsspital Bern /ID# 141886
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 143940
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hosp /ID# 143955
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital /ID# 143941
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust /ID# 142652
state: London, City Of
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust /ID# 154592
city: Cardiff
country: United Kingdom
facility: Velindre University NHS Trust /ID# 141996
city: Dundee
country: United Kingdom
facility: Duplicate_NHS Tayside /ID# 141651
city: Edinburgh
country: United Kingdom
facility: NHS Lothian /ID# 141802
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust /ID# 141653
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust /ID# 142658
city: Newcastle Upon Tyne
country: United Kingdom
facility: Duplicate_The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 141999
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital /ID# 142827
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
citation: Lassman AB, van den Bent MJ, Gan HK, Reardon DA, Kumthekar P, Butowski N, Lwin Z, Mikkelsen T, Nabors LB, Papadopoulos KP, Penas-Prado M, Simes J, Wheeler H, Walbert T, Scott AM, Gomez E, Lee HJ, Roberts-Rapp L, Xiong H, Ansell PJ, Bain E, Holen KD, Maag D, Merrell R. Safety and efficacy of depatuxizumab mafodotin + temozolomide in patients with EGFR-amplified, recurrent glioblastoma: results from an international phase I multicenter trial. Neuro Oncol. 2019 Jan 1;21(1):106-114. doi: 10.1093/neuonc/noy091.
citation: Gan HK, Reardon DA, Lassman AB, Merrell R, van den Bent M, Butowski N, Lwin Z, Wheeler H, Fichtel L, Scott AM, Gomez EJ, Fischer J, Mandich H, Xiong H, Lee HJ, Munasinghe WP, Roberts-Rapp LA, Ansell PJ, Holen KD, Kumthekar P. Safety, pharmacokinetics, and antitumor response of depatuxizumab mafodotin as monotherapy or in combination with temozolomide in patients with glioblastoma. Neuro Oncol. 2018 May 18;20(6):838-847. doi: 10.1093/neuonc/nox202.
citation: Reardon DA, Lassman AB, van den Bent M, Kumthekar P, Merrell R, Scott AM, Fichtel L, Sulman EP, Gomez E, Fischer J, Lee HJ, Munasinghe W, Xiong H, Mandich H, Roberts-Rapp L, Ansell P, Holen KD, Gan HK. Efficacy and safety results of ABT-414 in combination with radiation and temozolomide in newly diagnosed glioblastoma. Neuro Oncol. 2017 Jul 1;19(7):965-975. doi: 10.1093/neuonc/now257.