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)
Who is this study for? Adult patients with Glioblastoma
What treatments are being studied? Depatuxizumab
Status: Completed
Location: See all (207) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: No
View:
• 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).
Locations
United States
Arkansas
Highlands Oncology Group Springdale /ID# 142050
Springdale
Arizona
St. Josephs Hospital and Med Center /ID# 144149
Phoenix
California
University of California, Los Angeles /ID# 149239
Los Angeles
University of Southern California /ID# 147543
Los Angeles
Sharp Memorial Hospital /ID# 148193
San Diego
Univ California, San Francisco /ID# 145889
San Francisco
Duplicate_St. John's Health Center /ID# 148192
Santa Monica
Cedars-Sinai Medical Center-West Hollywood /ID# 148472
West Hollywood
Colorado
Univ of Colorado Cancer Center /ID# 148194
Aurora
Connecticut
Associated Neurologists of Sou /ID# 147701
Fairfield
Yale University /ID# 144170
New Haven
Delaware
Christiana Care Health Service /ID# 144127
Newark
Florida
Boca Raton Regional Hospital /ID# 163659
Boca Raton
Holy Cross Hospital /ID# 156764
Fort Lauderdale
Baptist Hospital Miami /ID# 152451
Miami
Advent Health /ID# 144128
Orlando
Moffitt Cancer Center /ID# 144130
Tampa
Georgia
Emory Midtown Infectious Disease Clinic /ID# 144015
Atlanta
Piedmont Hospital /ID# 145892
Atlanta
Illinois
Northwestern University Feinberg School of Medicine /ID# 147895
Chicago
The University of Chicago Medical Center /ID# 144158
Chicago
NorthShore University HealthSystem /ID# 144017
Evanston
Northwestern Medicine Cancer Center - Warrenville /ID# 148476
Warrenville
Indiana
Parkview Research Ctr, Hosp /ID# 144150
Fort Wayne
Kansas
Univ Kansas Cancer Ctr - Overl /ID# 145895
Westwood
Massachusetts
Dana-Farber Cancer Institute /ID# 148475
Boston
Massachusetts General Hospital /ID# 144145
Boston
Tufts Medical Center /ID# 145897
Boston
Maine
Maine Medical Partners Neurolo /ID# 160864
Scarborough
Michigan
Henry Ford Health System /ID# 145896
Detroit
Wayne State University /ID# 145890
Detroit
Duplicate_St. Joseph Mercy Hospital /ID# 144143
Ypsilanti
Minnesota
Mmcorc /Id# 144146
Saint Louis Park
Missouri
Washington University-School of Medicine /ID# 144174
Saint Louis
North Carolina
Levine Cancer Ins, Carolina Me /ID# 144124
Charlotte
Nebraska
Nebraska Methodist Hospital /ID# 144140
Omaha
University of Nebraska Medical Center /ID# 145899
Omaha
New Jersey
MD Anderson Cancer Center at Cooper - Camden /ID# 145891
Camden
Rutgers Cancer Institute of New Jersey /ID# 148190
New Brunswick
New York
Columbia University Medical Center /ID# 144020
New York
Univ Rochester Med Ctr /ID# 144166
Rochester
Ohio
University of Cincinnati /ID# 144164
Cincinnati
Cleveland Clinic Main Campus /ID# 144023
Cleveland
Duplicate_Univ Hosp Cleveland /ID# 144153
Cleveland
The Ohio State University /ID# 144016
Columbus
University of Toledo /ID# 156763
Toledo
Oklahoma
Univ Oklahoma HSC /ID# 144161
Oklahoma City
Pennsylvania
St. Luke's Hospital /ID# 148191
Bethlehem
Penn State University and Milton S. Hershey Medical Center /ID# 147525
Hershey
Fox Chase Cancer Center /ID# 145893
Philadelphia
Thomas Jefferson University /ID# 144191
Philadelphia
University of Pennsylvania /ID# 157623
Philadelphia
Allegheny General Hospital /ID# 144126
Pittsburgh
University of Pennsylvania Medical Center - Shadyside /ID# 144159
Pittsburgh
South Carolina
Medical University of South Carolina /ID# 144141
Charleston
Texas
Austin Cancer Centers /ID# 151061
Austin
Baylor Sammons Cancer Center /ID# 155542
Dallas
The University of Texas Health Science Center at Houston /ID# 144013
Houston
University of Texas MD Anderson Cancer Center /ID# 144018
Houston
Duplicate_Scott and White Medical Center /ID# 160743
Temple
Utah
Intermountain Medical Center /ID# 144142
Murray
University of Utah /ID# 144160
Salt Lake City
Virginia
Inova Health System /ID# 152956
Falls Church
Virginia Commonwealth University Medical Center Main Hospital /ID# 149014
Richmond
Washington
University of Washington /ID# 144162
Seattle
Virginia Mason Medical Center /ID# 144022
Seattle
Wisconsin
Univ of Wisconsin Hosp/Clinics /ID# 144167
Madison
Froedtert Memorial Lutheran Hospital /ID# 144139
Milwaukee
Other Locations
Argentina
Duplicate_Instituto Med Alex Flem /ID# 142884
Buenos Aires
Sanatorio Parque /ID# 142825
Rosario
Australia
Calvary North Adelaide Hospita /ID# 143866
Adelaide
Royal Adelaide Hospital /ID# 143867
Adelaide
St Vincent's Hospital Melbourne /ID# 143858
Fitzroy Melbourne
Duplicate_Austin Hospital /ID# 143859
Heidelberg
Liverpool Hospital /ID# 144392
Liverpool
Duplicate_The Prince of Wales Hospital /ID# 144882
Randwick
Royal North Shore Hospital /ID# 143870
St Leonards
St John Of God Subiaco Hospital /ID# 143869
Subiaco
Calvary Mater Newcastle /ID# 143860
Waratah
Southern Medical Day Care Centre /ID# 143868
Wollongong
Princess Alexandra Hospital /ID# 143857
Woolloongabba
Austria
Medizinische Universitaet Graz /ID# 141982
Graz
Duplicate_Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Mediz /ID# 141984
Innsbruck
Kepler Universitätsklinikum GmbH - Neuromed Campus /ID# 141983
Linz
Medizinische Universitaet Wien /ID# 141981
Vienna
Belgium
Grand Hopital de Charleroi /ID# 141645
Charleroi
UZ Gent /ID# 141647
Gent
Duplicate_Centre Hospitalier Jolimont /ID# 143873
La Louvière
Universitair Ziekenhuis Leuven /ID# 143872
Leuven
CHU de Liege /ID# 162860
Liege
UCL Saint-Luc /ID# 141648
Woluwe-saint-lambert
Duplicate_UCL Mont Godinne /ID# 141644
Yvoir
Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 143876
Barretos
Liga Norte Riograndense Contra o Câncer /ID# 143878
Natal
Hospital Sao Lucas da PUCRS /ID# 143879
Porto Alegre
Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 143877
Rio De Janeiro
Instituto do Câncer do Estado de São Paulo - ICESP /ID# 144031
São Paulo
Canada
QE II Health Sciences Centre /ID# 151600
Halifax
Juravinski Cancer Centre /ID# 152117
Hamilton
Victoria Hospital /ID# 144184
London
Duplicate_Hospital Maisonneuve-Rosemont /ID# 149315
Montreal
Duplicate_Jewish General Hospital /ID# 144029
Montreal
Royal Victoria Hospital / McGill University Health Centre /ID# 144187
Montreal
CHUM - Notre-Dame Hospital /ID# 144027
Montréal
Ottawa Hospital Research Institute /ID# 150120
Ottawa
CHU de Quebec-Universite Laval /ID# 144189
Quebec City
CHUS - Hopital Fleurimont /ID# 149771
Sherbrooke
Princess Margaret Cancer Centre /ID# 166277
Toronto
Duplicate_Cancer Care Manitoba /ID# 149253
Winnipeg
China
Beijing Tian Tan Hospital, Capital Medical University /ID# 167160
Beijing
Peking Union Medical College Hospital /ID# 157430
Beijing
SanboBrain Hospital Capital Medical University /ID# 166422
Beijing
Duplicate_Xiangya Hospital Central South University /ID# 166791
Changsha
The First Affiliated Hospital of Fujian Medical University /ID# 159166
Fuzhou
Sun Yat-Sen University Cancer Center /ID# 143919
Guangzhou
Duplicate_The Second Affiliated Hospital of ZUSM /ID# 165593
Hangzhou
Anhui Provincial Hospital /ID# 166320
Hefei
Duplicate_Huashan Hospital of Fudan University /ID# 159999
Shanghai
Duplicate_Shengjing Hospital of China Medical University /ID# 167016
Shenyang
The First Affiliated Hospital of Soochow University /ID# 165596
Suzhou
Duplicate_Tianjin Med Univ General Hosp /ID# 143923
Tianjin
Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 163820
Wuhan
Duplicate_Tangdu Hospital /ID# 143920
Xi'an
Colombia
Administradora del Country_S.A-Clinica Del Country /ID# 143881
Bogota
Centro Medico Imbanaco de Cali /ID# 143882
Cali
Hospital Pablo Tobon Uribe /ID# 143780
Medellín
Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 147223
Monteria
Oncologos del Occidente S.A /ID# 147713
Pereira
France
Insititut de Cancerologie /ID# 143908
Angers
Hopital Avicenne - APHP /ID# 143910
Bobigny
CHRU Lille - Hopital Claude Huriez /ID# 143915
Lille
AP-HM - Hopital de la Timone /ID# 143911
Marseille Cedex 05
CHU Nice -Hopital Pasteur /ID# 143916
Nice Cedex 1
Hopital Pitie Salpetriere /ID# 143917
Paris
Institut de Cancérologie de l'Ouest René Gauducheau /ID# 143914
St Herblain Cedex
Duplicate_Gustave Roussy /ID# 143912
Villejuif Cedex
Germany
Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH /ID# 143961
Bochum
Universitaetsklinik Heidelberg /ID# 143927
Heidelberg
Universitaetsklinikum Leipzig /ID# 143962
Leipzig
Universitaetsklinikum Tuebingen /ID# 143926
Tubingen
Hong Kong Special Administrative Region
Prince of Wales Hospital /ID# 143952
Hong Kong
Ireland
Beaumont Hospital /ID# 142969
Beaumont
Israel
Rambam Health Care Campus /ID# 143959
Haifa
Gastroenterology Institute, Division of Medicine /ID# 143958
Jerusalem
Rabin Medical Center /ID# 143957
Petakh Tikva
The Chaim Sheba Medical Center /ID# 143960
Ramat Gan
Tel Aviv Sourasky Medical Center /ID# 143956
Tel Aviv-yafo
Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 141800
Milan
Istituto Oncologico Veneto /ID# 143821
Padova
Duplicate_Regina Elena National Cancer I /ID# 141795
Rome
Duplicate_Duplicate_AOU Citta della Salute Scienza /ID# 141801
Turin
Mexico
Centro Medico Zambrano Hellion /ID# 143845
San Pedro Garza Garcia
Netherlands
Vrije Universiteit Medisch Centrum /ID# 143889
Amsterdam
Haaglanden Medisch Centrum /ID# 141405
Den Haag
Universitair Medisch Centrum Groningen /ID# 141408
Groningen
Maastricht Universitair Medisch Centrum /ID# 143585
Maastricht
Universitair Medisch Centrum Utrecht /ID# 141406
Utrecht
New Zealand
Duplicate_Canterbury District Health Boa /ID# 143861
Christchurch
Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 143890
Wellington
Portugal
CCA Braga - Hospital de Braga /ID# 141940
Braga
Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 141939
Faro
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 141941
Lisboa
IPO Lisboa FG, EPE /ID# 141938
Lisboa
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 142830
Porto
Republic of Korea
National Cancer Center /ID# 141845
Goyang
Duplicate_Yonsei University Health System, Severance hospital. /ID# 141846
Seoul
Samsung Medical Center /ID# 143887
Seoul
Seoul National University Hospital /ID# 143886
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 141844
Seoul
Russian Federation
Regional Clinical Hospital of Kaliningrad region /ID# 141702
Kaliningrad
Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 141707
Moscow
Federal State Treatment and Rehabilitation center /ID# 141704
Moscow
GEMC - European Medical Center /ID# 141703
Moscow
National Medical Research Center for Neurosurgery n.a. N. N. Burdenko /ID# 141701
Moscow
State budgetary healthcare institution Republican Clinical Oncology Dispensary /ID# 141706
Ufa
Sverdlovsk Regional Oncology Dispensary /ID# 141700
Yekaterinburg
Singapore
National Cancer Ctr Singapore /ID# 143932
Singapore
National University Hospital /ID# 143933
Singapore
South Africa
University of Free State, Universitas Annex (National Hospital Grounds) /ID# 144064
Bloemfontein
Duplicate_Cape Town Oncology Trials /ID# 143948
Cape Town
Netcare Oncology Intervent Ctr /ID# 143951
Cape Town
Rondebosch Oncology Center /ID# 143949
Cape Town
Netcare Unitas Hospital /ID# 152936
Centurion
The Oncology Centre /ID# 143950
Durban
Spain
Hospital Clinic de Barcelona /ID# 143906
Barcelona
Hospital Santa Creu i Sant Pau /ID# 143900
Barcelona
Hospital Clinico Universitario San Carlos /ID# 143901
Madrid
Hospital Universitario 12 de Octubre /ID# 143930
Madrid
Hospital Universitario HM Sanchinarro /ID# 143496
Madrid
Hospital Regional de Malaga /ID# 143902
Málaga
Hospital General Universitario de Valencia /ID# 143903
Valencia
Switzerland
Kantonsspital Aarau AG /ID# 141885
Aarau
Duplicate_EOC Ospedale Regionale di Bellinzona e Valli /ID# 143936
Bellinzona
Inselspital, Universitätsspital Bern /ID# 141886
Bern
Universitätsspital Zürich /ID# 141887
Zürich
Taiwan
National Taiwan University Hospital /ID# 143940
Taipei City
Taipei Veterans General Hosp /ID# 143955
Taipei City
Linkou Chang Gung Memorial Ho /ID# 143941
Taoyuan City
United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 154592
Birmingham
Velindre University NHS Trust /ID# 141996
Cardiff
Duplicate_NHS Tayside /ID# 141651
Dundee
NHS Lothian /ID# 141802
Edinburgh
Leeds Teaching Hospitals NHS Trust /ID# 141653
Leeds
Guy's and St Thomas' NHS Foundation Trust /ID# 142652
London
University College London Hospitals NHS Foundation Trust /ID# 142658
London
Duplicate_The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 141999
Newcastle Upon Tyne
Duplicate_Royal Marsden Hospital /ID# 142827
Sutton
Time Frame
Start Date: December 7, 2015
Completion Date: April 4, 2022
Participants
Target number of participants: 655
Treatments
Experimental: ABT-414, Radiation and Radiation/Temozolomide (TMZ)
ABT-414 is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. ABT-414 is given on Day 1 & 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
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 & 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
Authors
Nicholas Blondin, Adam Nowlan, Andrew Lassman, Jennifer Connelly, Yuhchyau Chen, Ian Crocker, Naveed Wagle, Ryan Merrell, Minesh Mehta, Stephanie Weiss, Lia Halasz, Brian Vaillant, Brian Chang, Santosh Kesari, Robert Aiken, Adam Cohen, Tulika Ranjan, Ashley Sumrall, Priya Kumthekar, Lynne Taylor, Lisa Rogers, Nicholas Butowski, Christina Tsien, David Cachia, H. Ian Robins
Related Therapeutic Areas
Sponsors
Leads: AbbVie
Collaborators: Radiation Therapy Oncology Group