A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1)

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)

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.

Study Overview

• Status: Completed
• Conditions: Glioblastoma; Gliosarcoma
• Intervention / Treatment: Radiation: Radiation; Drug: Temozolomide; Drug: Depatuxizumab mafodotin; Drug: Placebo for ABT-414

• Study Type: Interventional
• Enrollment (Actual): 691
• Phase: Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1426
    • Duplicate_Instituto Med Alex Flem /ID# 142884
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Sanatorio Parque /ID# 142825
• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital /ID# 144392
    • Randwick, New South Wales, Australia, 2031
      • Duplicate_The Prince of Wales Hospital /ID# 144882
    • St Leonards, New South Wales, Australia, 2065
      • Royal North Shore Hospital /ID# 143870
    • Waratah, New South Wales, Australia, 2298
      • Calvary Mater Newcastle /ID# 143860
    • Wollongong, New South Wales, Australia, 2500
      • Southern Medical Day Care Centre /ID# 143868
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital /ID# 143857
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital /ID# 143867
    • Adelaide, South Australia, Australia, 5006
      • Calvary North Adelaide Hospita /ID# 143866
  • Victoria
    • Fitzroy Melbourne, Victoria, Australia, 3065
      • St Vincent's Hospital Melbourne /ID# 143858
    • Heidelberg, Victoria, Australia, 3084
      • Duplicate_Austin Hospital /ID# 143859
  • Western Australia
    • Subiaco, Western Australia, Australia, 6008
      • St John Of God Subiaco Hospital /ID# 143869
• Austria
  • Innsbruck, Austria, 6020
    • Duplicate_Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Mediz /ID# 141984
  • Linz, Austria, 4020
    • Kepler Universitätsklinikum GmbH - Neuromed Campus /ID# 141983
  • Steiermark
    • Graz, Steiermark, Austria, 8036
      • Medizinische Universitaet Graz /ID# 141982
  • Wien
    • Vienna, Wien, Austria, 1090
      • Medizinische Universitaet Wien /ID# 141981
• Belgium
  • La Louvière, Belgium, 7100
    • Duplicate_Centre Hospitalier Jolimont /ID# 143873
  • Liege, Belgium, 4000
    • CHU de Liege /ID# 162860
  • Yvoir, Belgium, 5530
    • Duplicate_UCL Mont Godinne /ID# 141644
  • Bruxelles-Capitale
    • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
      • UCL Saint-Luc /ID# 141648
  • Hainaut
    • Charleroi, Hainaut, Belgium, 6000
      • Grand Hopital de Charleroi /ID# 141645
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • UZ Gent /ID# 141647
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Universitair Ziekenhuis Leuven /ID# 143872
• Brazil
  • Rio de Janeiro, Brazil, 20231-050
    • Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 143877
  • Rio Grande Do Norte
    • Natal, Rio Grande Do Norte, Brazil, 59075-740
      • Liga Norte Riograndense Contra o Câncer /ID# 143878
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
      • Hospital Sao Lucas da PUCRS /ID# 143879
  • Sao Paulo
    • Barretos, Sao Paulo, Brazil, 14784-400
      • Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 143876
    • São Paulo, Sao Paulo, Brazil, 01246-000
      • Instituto do Câncer do Estado de São Paulo - ICESP /ID# 144031
• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • Duplicate_Cancer Care Manitoba /ID# 149253
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • QE II Health Sciences Centre /ID# 151600
  • Ontario
    • Hamilton, Ontario, Canada, L8V 1C3
      • Juravinski Cancer Centre /ID# 152117
    • London, Ontario, Canada, N6A 4L6
      • Victoria Hospital /ID# 144184
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital Research Institute /ID# 150120
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre /ID# 166277
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Duplicate_Hospital Maisonneuve-Rosemont /ID# 149315
    • Montreal, Quebec, Canada, H3T 1E2
      • Duplicate_Jewish General Hospital /ID# 144029
    • Montreal, Quebec, Canada, H4A 3J1
      • Royal Victoria Hospital / McGill University Health Centre /ID# 144187
    • Montréal, Quebec, Canada, H2X 0A9
      • CHUM - Notre-Dame Hospital /ID# 144027
    • Quebec City, Quebec, Canada, G1R 2J6
      • CHU de Quebec-Universite Laval /ID# 144189
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • CHUS - Hopital Fleurimont /ID# 149771
• China
  • Beijing, China, 100070
    • Beijing Tian Tan Hospital, Capital Medical University /ID# 167160
  • Fuzhou, China, 350005
    • The First Affiliated Hospital of Fujian Medical University /ID# 159166
  • Shenyang, China, 110004
    • Duplicate_Shengjing Hospital of China Medical University /ID# 167016
  • Tianjin, China, 300052
    • Duplicate_Tianjin Med Univ General Hosp /ID# 143923
  • Anhui
    • Hefei, Anhui, China, 230001
      • Anhui Provincial Hospital /ID# 166320
  • Beijing
    • Beijing, Beijing, China, 100042
      • SanboBrain Hospital Capital Medical University /ID# 166422
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital /ID# 157430
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-Sen University Cancer Center /ID# 143919
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Tongji Medical College of HUST /ID# 163820
  • Hunan
    • Changsha, Hunan, China, 410008
      • Duplicate_Xiangya Hospital Central South University /ID# 166791
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University /ID# 165596
  • Shaanxi
    • Xi'an, Shaanxi, China, 710038
      • Duplicate_Tangdu Hospital /ID# 143920
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Duplicate_Huashan Hospital of Fudan University /ID# 159999
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Duplicate_The Second Affiliated Hospital of ZUSM /ID# 165593
• Colombia
  • Cali, Colombia
    • Centro Medico Imbanaco de Cali /ID# 143882
  • Antioquia
    • Medellín, Antioquia, Colombia, 50034
      • Hospital Pablo Tobon Uribe /ID# 143780
  • Cordoba
    • Monteria, Cordoba, Colombia, 230002
      • Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 147223
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 110221
      • Administradora del Country_S.A-Clinica Del Country /ID# 143881
  • Risaralda
    • Pereira, Risaralda, Colombia, 66000
      • Oncologos del Occidente S.A /ID# 147713
• Czechia
  • Brno, Czechia, 656 53
    • Masarykuv onkologicky ustav /ID# 143884
  • Hradec Kralove, Czechia, 500 05
    • Duplicate_FN Hradec Kralove /ID# 143885
  • Liberec, Czechia, 460 01
    • Krajska nemocnice Liberec, a.s. /ID# 142024
  • Ostrava, Czechia, 708 52
    • Duplicate_Univ Hosp Ostrava-Poruba /ID# 143883
  • Praha, Czechia, 150 06
    • Fakultni Nemocnice v Motole /ID# 142023
• France
  • Angers, France, 49933
    • Insititut de Cancerologie /ID# 143908
  • Paris, France, 75013
    • Hopital Pitie Salpetriere /ID# 143917
  • Bouches-du-Rhone
    • Marseille CEDEX 05, Bouches-du-Rhone, France, 13385
      • AP-HM - Hopital de la Timone /ID# 143911
  • Hauts-de-France
    • Lille, Hauts-de-France, France, 59037
      • CHRU Lille - Hopital Claude Huriez /ID# 143915
  • Ile-de-France
    • Bobigny, Ile-de-France, France, 93000
      • Hopital Avicenne - APHP /ID# 143910
    • Villejuif Cedex, Ile-de-France, France, 94805
      • Duplicate_Gustave Roussy /ID# 143912
  • Loire-Atlantique
    • St Herblain CEDEX, Loire-Atlantique, France, 44805
      • Institut de Cancérologie de l'Ouest René Gauducheau /ID# 143914
  • Provence-Alpes-Cote-d Azur
    • Nice CEDEX 1, Provence-Alpes-Cote-d Azur, France, 06002
      • CHU Nice -Hopital Pasteur /ID# 143916
• Germany
  • Bochum, Germany, 44791
    • Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH /ID# 143961
  • Baden-Wuerttemberg
    • Heidelberg, Baden-Wuerttemberg, Germany, 69120
      • Universitaetsklinik Heidelberg /ID# 143927
    • Tubingen, Baden-Wuerttemberg, Germany, 72076
      • Universitaetsklinikum Tuebingen /ID# 143926
  • Sachsen
    • Leipzig, Sachsen, Germany, 04103
      • Universitaetsklinikum Leipzig /ID# 143962
• Hong Kong
  • Hong Kong, Hong Kong, 999077
    • Prince of Wales Hospital /ID# 143952
• Ireland
  • Dublin
    • Beaumont, Dublin, Ireland, D09 XR63
      • Beaumont Hospital /ID# 142969
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus /ID# 143959
  • Jerusalem, Israel, 91120
    • Gastroenterology Institute, Division of Medicine /ID# 143958
  • Petakh Tikva, Israel, 4941492
    • Rabin Medical Center /ID# 143957
  • Tel-Aviv
    • Ramat Gan, Tel-Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 143960
    • Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 143956
• Italy
  • Milan, Italy, 20133
    • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 141800
  • Padova, Italy, 35128
    • Istituto Oncologico Veneto /ID# 143821
  • Rome, Italy, 00144
    • Duplicate_Regina Elena National Cancer I /ID# 141795
  • Piemonte
    • Turin, Piemonte, Italy, 10126
      • Duplicate_Duplicate_AOU Citta della Salute Scienza /ID# 141801
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital /ID# 143886
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center /ID# 143887
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 141844
  • Gyeonggido
    • Goyang, Gyeonggido, Korea, Republic of, 10408
      • National Cancer Center /ID# 141845
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
      • Duplicate_Yonsei University Health System, Severance hospital. /ID# 141846
• Mexico
  • Nuevo Leon
    • San Pedro Garza Garcia, Nuevo Leon, Mexico, 66278
      • Centro Medico Zambrano Hellion /ID# 143845
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Vrije Universiteit Medisch Centrum /ID# 143889
  • Den Haag, Netherlands, 2512 VA
    • Haaglanden Medisch Centrum /ID# 141405
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen /ID# 141408
  • Maastricht, Netherlands, 6229 HX
    • Maastricht Universitair Medisch Centrum /ID# 143585
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht /ID# 141406
• New Zealand
  • Christchurch, New Zealand, 8011
    • Duplicate_Canterbury District Health Boa /ID# 143861
  • Wellington, New Zealand, 6021
    • Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 143890
• Portugal
  • Braga, Portugal, 4710-243
    • CCA Braga - Hospital de Braga /ID# 141940
  • Faro, Portugal, 8000-386
    • Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 141939
  • Lisboa, Portugal, 1099-023
    • IPO Lisboa FG, EPE /ID# 141938
  • Lisboa, Portugal, 1649-035
    • Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 141941
  • Porto, Portugal, 4200-319
    • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 142830
• Russian Federation
  • Kaliningradskaya Oblast
    • Kaliningrad, Kaliningradskaya Oblast, Russian Federation, 236016
      • Regional Clinical Hospital of Kaliningrad region /ID# 141702
  • Kirovskaya Oblast
    • Ufa, Kirovskaya Oblast, Russian Federation, 450054
      • State budgetary healthcare institution Republican Clinical Oncology Dispensary /ID# 141706
  • Moskovskaya Oblast
    • Moscow, Moskovskaya Oblast, Russian Federation, 129090
      • GEMC - European Medical Center /ID# 141703
  • Moskva
    • Moscow, Moskva, Russian Federation, 115478
      • Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 141707
    • Moscow, Moskva, Russian Federation, 125047
      • National Medical Research Center for Neurosurgery n.a. N. N. Burdenko /ID# 141701
    • Moscow, Moskva, Russian Federation, 125367
      • Federal State Treatment and Rehabilitation center /ID# 141704
  • Sverdlovskaya Oblast
    • Yekaterinburg, Sverdlovskaya Oblast, Russian Federation, 620043
      • Sverdlovsk Regional Oncology Dispensary /ID# 141700
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital /ID# 143933
  • Singapore, Singapore, 169610
    • National Cancer Ctr Singapore /ID# 143932
• South Africa
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • University of Free State, Universitas Annex (National Hospital Grounds) /ID# 144064
  • Gauteng
    • Centurion, Gauteng, South Africa, 0140
      • Netcare Unitas Hospital /ID# 152936
  • Kwazulu-Natal
    • Durban, Kwazulu-Natal, South Africa, 4091
      • The Oncology Centre /ID# 143950
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7460
      • Netcare Oncology Intervent Ctr /ID# 143951
    • Cape Town, Western Cape, South Africa, 7700
      • Rondebosch Oncology Center /ID# 143949
    • Kraaifontein, Western Cape, South Africa, 7570
      • Cape Town Oncology Trials /ID# 143948
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona /ID# 143906
  • Barcelona, Spain, 08041
    • Hospital Santa Creu i Sant Pau /ID# 143900
  • Madrid, Spain, 28040
    • Hospital Clinico Universitario San Carlos /ID# 143901
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre /ID# 143930
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro /ID# 143496
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia /ID# 143903
  • Malaga
    • Málaga, Malaga, Spain, 29010
      • Hospital Regional de Malaga /ID# 143902
• Switzerland
  • Bellinzona, Switzerland, 6500
    • Duplicate_EOC Ospedale Regionale di Bellinzona e Valli /ID# 143936
  • Bern, Switzerland, 3010
    • Inselspital, Universitätsspital Bern /ID# 141886
  • Aargau
    • Aarau, Aargau, Switzerland, 5001
      • Kantonsspital Aarau AG /ID# 141885
  • Zuerich
    • Zurich, Zuerich, Switzerland, 8091
      • Universitatsspital Zurich /ID# 141887
• Taiwan
  • Taipei City, Taiwan, 100
    • National Taiwan University Hospital /ID# 143940
  • Taipei City, Taiwan, 11217
    • Taipei Veterans General Hosp /ID# 143955
  • Taoyuan City, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital /ID# 143941
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • University Hospitals Birmingham NHS Foundation Trust /ID# 154592
  • Cardiff, United Kingdom, CF15 7QZ
    • Velindre University NHS Trust /ID# 141996
  • Dundee, United Kingdom, DD2 1UB
    • Duplicate_NHS Tayside /ID# 141651
  • Edinburgh, United Kingdom, EH3 9HE
    • NHS Lothian /ID# 141802
  • Leeds, United Kingdom, LS9 7TF
    • Leeds Teaching Hospitals NHS Trust /ID# 141653
  • London, United Kingdom, NW1 2PG
    • University College London Hospitals NHS Foundation Trust /ID# 142658
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
    • Duplicate_The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 141999
  • Sutton, United Kingdom, SM2 5PT
    • Royal Marsden Hospital /ID# 142827
  • London, City Of
    • London, London, City Of, United Kingdom, SE1 9RT
      • Guys and St Thomas NHS Foundation Trust /ID# 142652
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • St. Josephs Hospital and Med Center /ID# 144149
  • Arkansas
    • Springdale, Arkansas, United States, 72762
      • Highlands Oncology Group, PA /ID# 142050
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California /ID# 147543
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles /ID# 149239
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital /ID# 148193
    • San Francisco, California, United States, 94143-2204
      • Univ California, San Francisco /ID# 145889
    • Santa Monica, California, United States, 90404
      • Duplicate_St. John's Health Center /ID# 148192
    • West Hollywood, California, United States, 90048
      • Cedars-Sinai Medical Center-West Hollywood /ID# 148472
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Univ of Colorado Cancer Center /ID# 148194
  • Connecticut
    • Fairfield, Connecticut, United States, 06824
      • Associated Neurologists of Sou /ID# 147701
    • New Haven, Connecticut, United States, 06510
      • Yale University /ID# 144170
  • Delaware
    • Newark, Delaware, United States, 19713
      • Christiana Care Health Service /ID# 144127
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Boca Raton Regional Hospital /ID# 163659
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital /ID# 156764
    • Miami, Florida, United States, 33176
      • Baptist Hospital Miami /ID# 152451
    • Orlando, Florida, United States, 32803
      • Advent Health /ID# 144128
    • Tampa, Florida, United States, 33612-9416
      • Moffitt Cancer Center /ID# 144130
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Hospital /ID# 145892
    • Atlanta, Georgia, United States, 30322
      • Emory Midtown Infectious Disease Clinic /ID# 144015
  • Illinois
    • Chicago, Illinois, United States, 60611-2927
      • Northwestern University Feinberg School of Medicine /ID# 147895
    • Chicago, Illinois, United States, 60637-1443
      • The University of Chicago Medical Center /ID# 144158
    • Evanston, Illinois, United States, 60201
      • NorthShore University HealthSystem /ID# 144017
    • Warrenville, Illinois, United States, 60555
      • Northwestern Medicine Cancer Center - Warrenville /ID# 148476
  • Indiana
    • Fort Wayne, Indiana, United States, 46805
      • Parkview Research Ctr, Hosp /ID# 144150
  • Kansas
    • Westwood, Kansas, United States, 66205-2003
      • Univ Kansas Cancer Ctr - Overl /ID# 145895
  • Maine
    • Scarborough, Maine, United States, 04074
      • Maine Medical Partners Neurolo /ID# 160864
  • Massachusetts
    • Boston, Massachusetts, United States, 02111-1552
      • Tufts Medical Center /ID# 145897
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital /ID# 144145
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute /ID# 148475
  • Michigan
    • Detroit, Michigan, United States, 48201-2013
      • Wayne State University /ID# 145890
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System /ID# 145896
    • Ypsilanti, Michigan, United States, 48197
      • Duplicate_St. Joseph Mercy Hospital /ID# 144143
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • Mmcorc /Id# 144146
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University-School of Medicine /ID# 144174
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Nebraska Methodist Hospital /ID# 144140
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center /ID# 145899
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • MD Anderson Cancer Center at Cooper - Camden /ID# 145891
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Cancer Institute of New Jersey /ID# 148190
  • New York
    • New York, New York, United States, 10032-3729
      • Columbia University Medical Center /ID# 144020
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center /ID# 144166
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Ins, Carolina Me /ID# 144124
  • Ohio
    • Cincinnati, Ohio, United States, 45267-0585
      • University of Cincinnati /ID# 144164
    • Cleveland, Ohio, United States, 44106
      • Duplicate_Univ Hosp Cleveland /ID# 144153
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Main Campus /ID# 144023
    • Columbus, Ohio, United States, 43210
      • The Ohio State University /ID# 144016
    • Toledo, Ohio, United States, 43614
      • University of Toledo /ID# 156763
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Univ Oklahoma HSC /ID# 144161
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • St. Luke's Hospital /ID# 148191
    • Hershey, Pennsylvania, United States, 17033
      • Penn State University and Milton S. Hershey Medical Center /ID# 147525
    • Philadelphia, Pennsylvania, United States, 19104-5502
      • University of Pennsylvania /ID# 157623
    • Philadelphia, Pennsylvania, United States, 19107-4414
      • Thomas Jefferson University /ID# 144191
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center /ID# 145893
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital /ID# 144126
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pennsylvania Medical Center - Shadyside /ID# 144159
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina /ID# 144141
  • Texas
    • Austin, Texas, United States, 78758
      • Austin Cancer Centers /ID# 151061
    • Dallas, Texas, United States, 75246
      • Baylor Sammons Cancer Center /ID# 155542
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston /ID# 144013
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center /ID# 144018
    • Temple, Texas, United States, 76508
      • Duplicate_Scott and White Medical Center /ID# 160743
  • Utah
    • Murray, Utah, United States, 84107-5701
      • Intermountain Medical Center /ID# 144142
    • Salt Lake City, Utah, United States, 84112-5500
      • University of Utah /ID# 144160
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Health System /ID# 152956
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University Medical Center Main Hospital /ID# 149014
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center /ID# 144022
    • Seattle, Washington, United States, 98109
      • University of Washington /ID# 144162
  • Wisconsin
    • Madison, Wisconsin, United States, 53792-0001
      • Univ of Wisconsin Hosp/Clinics /ID# 144167
    • Milwaukee, Wisconsin, United States, 53226-3522
      • Froedtert Memorial Lutheran Hospital /ID# 144139

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Depatuxizumab Mafodotin, Radiation and Temozolomide (TMZ); Depatuxizumab mafodotin is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.	Radiation: Radiation; Drug: Temozolomide; Oral Capsule; Drug: Depatuxizumab mafodotin; Intravenous (IV) Infusion; Other Names: ABT-414
Placebo Comparator: Placebo, Radiation and TMZ; Placebo is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Placebo is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.	Radiation: Radiation; Drug: Temozolomide; Oral Capsule; Drug: Placebo for ABT-414; IV Infusion (IV)
Experimental: Open-Label Sub-Study: Depatuxizumab Mafodotin, Radiation and TMZ; Depatuxizumab mafodotin is given to participants with hepatic impairment on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.	Radiation: Radiation; Drug: Temozolomide; Oral Capsule; Drug: Depatuxizumab mafodotin; Intravenous (IV) Infusion; Other Names: ABT-414

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.	Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS for the O6-methylguaninemethlytransferese (MGMT) Unmethylated Group	Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause. Unmethylated MGMT promoter is associated with a worse prognosis in GBM	Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
OS for the MGMT Methylated Group	Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.	Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
OS for the Epidermal Growth Factor Receptor (EGFR)vIII-Mutated Tumor Subgroup	Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.	Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Progression-Free Survival (PFS)	PFS will be defined as the number of days from the date of randomization to the date of earliest disease progression based on Response Assessment in Neuro-Oncology (RANO) criteria (see Wen et al. J Clin Oncol. 2010 Apr 10;28(11):1963-72) or to the date of death, if disease progression does not occur.	Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
PFS for EGFRvIII-Mutated Tumor Subgroup	PFS will be defined as the number of days from the date of randomization to the date of earliest disease progression based on Response Assessment in Neuro-Oncology (RANO) criteria or to the date of death, if disease progression does not occur.	Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Deterioration Free Survival in M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) Symptom Severity Score	The MDASI-BT assesses the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours. It consists of 22 symptom items and 6 interference items, each rated from 0 to 10. MDASI-BT symptom severity score is defined as average over 13 core symptom items and 9 brain tumor symptom items, with a total score of 0 to 10, with higher score indicating worse symptoms/interference. Changes in symptom severity score were classified into 3 categories: improved (≤ -1), stable (> -1 and < 1), and deteriorated (≥ 1). Deterioration is defined as satisfying the deterioration criteria (i.e., increase in symptom severity score by ≥ 1 unit) without further improvement (i.e., failing to satisfy deterioration criteria) within 8 weeks or occurrence of death.	Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Deterioration Free Survival in MDASI-BT Symptom Interference Score	The MDASI-BT assesses the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours. It consists of 22 symptom items and 6 interference items, each rated from 0 to 10. MDASI-BT symptom interference score is defined as an average of 6 interference items, with a total score of 0 to 10, where higher scores indicate worse interference. Changes in symptom interference score were classified into 3 categories: improved (≤ -1), stable (> -1 and < 1), and deteriorated (≥ 1). Deterioration is defined as satisfying the deterioration criteria (i.e., increase in symptom interference score by ≥ 1 unit) without further improvement (i.e., failing to satisfy deterioration criteria) within 8 weeks or occurrence of death.	Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Deterioration Free Survival in Neurocognitive Functioning on the Hopkins Verbal Learning Test Revised (HVLT-R) Total Recall Score	The HVLT-R consists of 3 parts. Free call has a range of 0 to 36, delayed recall has a range from 0 to 12, and delayed recognition has a range of -12 to 12. Higher scores indicating better function in all 3 parts. When scoring the HVLT-R, the 3 learning trials are combined to calculate a total recall score (range -12 to 60). Deterioration is defined as satisfying the deterioration criteria (i.e., decrease in HVLT-R total recall score by 5 units) without further improvement within 8 weeks or occurrence of death.	Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).

Collaborators and Investigators

• Sponsor: AbbVie
• Collaborators: Radiation Therapy Oncology Group
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• can search for the study and find research centers participating

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2015
• Primary Completion (Actual): April 4, 2022
• Study Completion (Actual): April 4, 2022

Study Registration Dates

• First Submitted: September 28, 2015
• First Submitted That Met QC Criteria: October 8, 2015
• First Posted (Estimate): October 9, 2015

Study Record Updates

• Last Update Posted (Actual): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Temozolomide; Brain Tumor; Brain Cancer; Antibody Drug Conjugate; EGFRvIII; ABT-414; Brain Tumor Group; First Line Therapy; Newly Diagnosed Glioblastoma; Epithelial Growth Factor Receptor (EGFR); Radiology Therapy Oncology Group; EGFR Amplified
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Gliosarcoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Temozolomide
• Other Study ID Numbers: M13-813; 2015-001166-26 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No