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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02573324
Recruitment Status : Active, not recruiting
First Posted : October 9, 2015
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
Radiation Therapy Oncology Group
Information provided by (Responsible Party):
AbbVie

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.


Condition or disease Intervention/treatment Phase
Glioblastoma Gliosarcoma Drug: Temozolomide Drug: ABT-414 Radiation: Radiation Drug: Placebo for ABT-414 Phase 2 Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 691 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 7, 2015
Estimated Primary Completion Date : July 18, 2020
Estimated Study Completion Date : July 18, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Temozolomide
oral

Radiation: Radiation
Drug: Placebo for ABT-414
intravenous infusion

Experimental: ABT-414, radiation and 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.
Drug: Temozolomide
oral

Drug: ABT-414
intravenous infusion
Other Names:
  • Depatuxizumab
  • Mafodotin

Radiation: Radiation



Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Quarterly after treatment discontinuation for approximately 4 years ]
    Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573324


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Locations
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United States, Arizona
St. Josephs Hosp and Med Ctr /ID# 144149
Phoenix, Arizona, United States, 85013
United States, Arkansas
Highlands Oncology Group /ID# 142050
Fayetteville, Arkansas, United States, 72703-4005
United States, California
Usc /Id# 147543
Los Angeles, California, United States, 90033
University of California, Los Angeles /ID# 149239
Los Angeles, California, United States, 90095
Sharp Memorial Hospital /ID# 148193
San Diego, California, United States, 92123
Univ California, San Francisco /ID# 145889
San Francisco, California, United States, 94143-2204
St. John's Health Center /ID# 148192
Santa Monica, California, United States, 90404
Cedars-Sinai Medical Center - West Hollywood /ID# 148472
West Hollywood, California, United States, 90048
United States, Colorado
Univ of Colorado Cancer Center /ID# 148194
Aurora, Colorado, United States, 80045
United States, Connecticut
Associated Neurologists of Sou /ID# 147701
Fairfield, Connecticut, United States, 06824
Yale University /ID# 144170
New Haven, Connecticut, United States, 06510
United States, Delaware
Christiana Care Health Service /ID# 144127
Newark, Delaware, United States, 19713
United States, Florida
Boca Raton Regional Hospital /ID# 163659
Boca Raton, Florida, United States, 33486
Holy Cross Hospital /ID# 156764
Fort Lauderdale, Florida, United States, 33308
Baptist Hospital Miami /ID# 152451
Miami, Florida, United States, 33176
Florida Hospital /ID# 144128
Orlando, Florida, United States, 32803
Moffitt Cancer Center /ID# 144130
Tampa, Florida, United States, 33612
United States, Georgia
Piedmont Hospital /ID# 145892
Atlanta, Georgia, United States, 30309
Emory University Hospital /ID# 144015
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University Feinberg School of Medicine /ID# 147895
Chicago, Illinois, United States, 60611-2927
University of Chicago /ID# 144158
Chicago, Illinois, United States, 60637-1443
NorthShore University HealthSystem - Evanston /ID# 144017
Evanston, Illinois, United States, 60201
NW Medical Cancer Ctr, Geneva /ID# 151568
Geneva, Illinois, United States, 60134
Northwestern Medicine Cancer Center - Warrenville /ID# 148476
Warrenville, Illinois, United States, 60555
United States, Indiana
Parkview Research Ctr, Hosp /ID# 144150
Fort Wayne, Indiana, United States, 46805
United States, Kansas
Univ Kansas Cancer Ctr - Overl /ID# 145895
Westwood, Kansas, United States, 66205-2003
United States, Maine
Maine Medical Partners Neurolo /ID# 160864
Scarborough, Maine, United States, 04074
United States, Massachusetts
Tufts Medical Center /ID# 145897
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital /ID# 144145
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute /ID# 148475
Boston, Massachusetts, United States, 02215
United States, Michigan
Wayne State University /ID# 145890
Detroit, Michigan, United States, 48201-2013
Henry Ford Health System /ID# 145896
Detroit, Michigan, United States, 48202
St. Joseph Mercy Hospital /ID# 144143
Ypsilanti, Michigan, United States, 48106
United States, Minnesota
Mmcorc /Id# 144146
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
Washington University-School of Medicine /ID# 144174
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Nebraska Methodist Hospital /ID# 144140
Omaha, Nebraska, United States, 68114
Univ Nebraska Med Ctr /ID# 145899
Omaha, Nebraska, United States, 68198
United States, New Jersey
MD Anderson Cancer Center at Cooper /ID# 145891
Camden, New Jersey, United States, 08103
Rutgers Cancer Institute of NJ /ID# 148190
New Brunswick, New Jersey, United States, 08903
United States, New York
Columbia Univ Medical Center /ID# 144020
New York, New York, United States, 10032-3725
Univ Rochester Med Ctr /ID# 144166
Rochester, New York, United States, 14642
United States, North Carolina
Levine Cancer Ins, Carolina Me /ID# 144124
Charlotte, North Carolina, United States, 28204
United States, Ohio
University of Cincinnati /ID# 144164
Cincinnati, Ohio, United States, 45267-0585
Univ Hosp Cleveland /ID# 144153
Cleveland, Ohio, United States, 44106
Cleveland Clinic Main Campus /ID# 144023
Cleveland, Ohio, United States, 44195
The Ohio State University - Columbus /ID# 144016
Columbus, Ohio, United States, 43210
University of Toledo /ID# 156763
Toledo, Ohio, United States, 43614
United States, Oklahoma
Univ Oklahoma HSC /ID# 144161
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
St. Luke's Hospital /ID# 148191
Bethlehem, Pennsylvania, United States, 18017
Penn State University and Milton S. Hershey Medical Center /ID# 147525
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania /ID# 157623
Philadelphia, Pennsylvania, United States, 19104-5502
Thomas Jefferson University /ID# 144191
Philadelphia, Pennsylvania, United States, 19107-4414
Fox Chase Cancer Center /ID# 145893
Philadelphia, Pennsylvania, United States, 19111
Allegheny General Hospital /ID# 144126
Pittsburgh, Pennsylvania, United States, 15212
UPMC - Shadyside /ID# 144159
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Medical University of South Carolina /ID# 144141
Charleston, South Carolina, United States, 29425
United States, Texas
Austin Cancer Centers /ID# 151061
Austin, Texas, United States, 78758
Baylor Sammons Cancer Center /ID# 155542
Dallas, Texas, United States, 75246
Univ TX, MD Anderson /ID# 144018
Houston, Texas, United States, 77030
UT Health Science Ctr-Houston /ID# 144013
Houston, Texas, United States, 77030
Scott and White Medical Center /ID# 160743
Temple, Texas, United States, 76508
United States, Utah
Intermountain Medical Center /ID# 144142
Murray, Utah, United States, 84107-5701
University of Utah /ID# 144160
Salt Lake City, Utah, United States, 84112-5500
United States, Virginia
Inova Health System /ID# 152956
Falls Church, Virginia, United States, 22042
Virginia Commonwealth Univ /ID# 149014
Richmond, Virginia, United States, 23219
United States, Washington
Virginia Mason Medical Center /ID# 144022
Seattle, Washington, United States, 98101
University of Washington /ID# 144162
Seattle, Washington, United States, 98109
United States, Wisconsin
Univ of Wisconsin Hosp/Clinics /ID# 144167
Madison, Wisconsin, United States, 53792-0001
Froedtert and Medical College /ID# 144139
Milwaukee, Wisconsin, United States, 53226-3522
Argentina
Instituto Med Alex Flem /ID# 142884
Buenos Aires, Argentina, C1426ANZ
Sanatorio Parque S.A. - Grupo /ID# 142825
Rosario, Santa FE, Argentina, 2000
Australia, New South Wales
Liverpool Hospital /ID# 144392
Liverpool, New South Wales, Australia, 2170
The Prince of Wales Hospital /ID# 144882
Randwick, New South Wales, Australia, 2031
Royal North Shore Hospital /ID# 143870
Saint Leonards, New South Wales, Australia, 2065
Calvary Mater Newcastle /ID# 143860
Waratah, New South Wales, Australia, 2298
Southern Medical Day Care Ctr /ID# 143868
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Princess Alexandra Hospital /ID# 143857
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital /ID# 143867
Adelaide, South Australia, Australia, 5000
Calvary North Adelaide Hospita /ID# 143866
Adelaide, South Australia, Australia, 5006
Australia, Victoria
St. Vincents Hosp Melbourne /ID# 143858
Fitzroy, Victoria, Australia, 3065
Austin Hospital /ID# 143859
Heidelberg, Victoria, Australia, 3084
Australia, Western Australia
St. John of God Subiaco Hosp /ID# 143869
Subiaco, Western Australia, Australia, 6008
Austria
Medizinische Universität Wien /ID# 141981
Vienna, Wien, Austria, 1090
LKH-Univ. Klinikum Graz /ID# 141982
Graz, Austria, 8036
Medical University Innsbruck /ID# 141984
Innsbruck, Austria, 6020
Kepler Universitätsklinikum GmbH - Neuromed Campus /ID# 141983
Linz, Austria, 4020
Belgium
Cliniques Universitaires Saint Luc /ID# 141648
Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
Grand Hôpital de Charleroi /ID# 141645
Charleroi, Hainaut, Belgium, 6000
CHU de Liege /ID# 162860
Liège, Liege, Belgium, 4000
UZ Gent /ID# 141647
Gent, Oost-Vlaanderen, Belgium, 9000
Centre Hospitalier Jolimont /ID# 143873
La Louvière, Belgium, 7100
UZ Leuven /ID# 143872
Leuven, Belgium, 3000
UCL Mont Godinne /ID# 141644
Yvoir, Belgium, 5530
Brazil
Liga Norte Rigrandese Contra o /ID# 143878
Natal, Rio Grande Do Norte, Brazil, 59062-000
Hospital Sao Lucas da PUCRS /ID# 143879
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
Hospital de Cancer de Barretos /ID# 143876
Barretos, Sao Paulo, Brazil, 14784-400
Icesp /Id# 144031
São Paulo, Sao Paulo, Brazil, 01246-000
Inca /Id# 143877
Rio de Janeiro, Brazil, 20231-050
Canada, Manitoba
Cancer Care Manitoba /ID# 149253
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
Qe Ii Hsc /Id# 151600
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Juravinski Cancer Clinic /ID# 152117
Hamilton, Ontario, Canada, L8V 1C3
Victoria Hospital /ID# 144184
London, Ontario, Canada, N6A 4L6
The Ottawa Hospital /ID# 150120
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Cancer Centr /ID# 166277
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Hospital Maisonneuve-Rosemont /ID# 149315
Montreal, Quebec, Canada, H1T 2M4
McGill Univ HC /ID# 144187
Montreal, Quebec, Canada, H3G 1A4
Jewish General Hospital /ID# 144029
Montreal, Quebec, Canada, H3T 1E2
CHUM - Notre-Dame Hospital /ID# 144027
Montréal, Quebec, Canada, H2X 0A9
CHU de Quebec-Universite Laval /ID# 144189
Quebec City, Quebec, Canada, G1R 2J6
CHUS - Hopital Fleurimont /ID# 149771
Sherbrooke, Quebec, Canada, J1H 5N4
China, Anhui
Anhui Provincial Hospital /ID# 166320
Hefei, Anhui, China, 230001
China, Jiangsu
1st Affil Hosp Soochow Univ /ID# 165596
Suzhou, Jiangsu, China, 215006
China, Shanghai
Huashan Hospital of Fudan University /ID# 159999
Shanghai, Shanghai, China, 200040
China, Zhejiang
The Second Affiliated Hospital /ID# 165593
Hangzhou, Zhejiang, China, 310009
China
Sanbo Brain Hospital Capital M /ID# 166422
Beijing, China, 100042
Beijing Tian Tan Hospital /ID# 167160
Beijing, China, 100070
Peking Union Medical College H /ID# 157430
Beijing, China, 100730
Xiangya Hospital Central South University /ID# 166791
Changsha, China, 410008
1st Affiliated Hosp Fujian Med /ID# 159166
Fuzhou, China, 350005
Sun Yat-Sen Uni Cancer Center /ID# 143919
Guangzhou, Guangdong, China, 510060
Shengjing Hospital of China Medical University /ID# 167016
Shenyang, China, 110004
Tianjin Med Univ General Hosp /ID# 143923
Tianjin, China, 300052
Tongji Hosp Tongji Med College /ID# 163820
Wuhan, China, 430030
Fourth Military Medical University Tangdu Hospital, PLA /ID# 143920
Xi'an, China, 710038
Colombia
Administradora del Country_S.A-Clinica Del Country /ID# 143881
Bogota, Cundinamarca, Colombia, 110221
Centro Medico Imbanaco de Cali /ID# 143882
Cali, Colombia
Hospital Pablo Tobon Uribe /ID# 143780
Medellín, Colombia
Inst Med Alta Tec Onc (IMAT) /ID# 147223
Montería, Colombia, 230002
Oncologos de Occidente SA /ID# 147713
Pereira, Colombia
Czechia
Fakultni Nemocnice v Motole /ID# 142023
Prague 5, Praha 5, Czechia, 150 06
Masarykuv onkologikcy ustav /ID# 143884
Brno, Czechia, 656 53
FN Hradec Kralove /ID# 143885
Hradec Kralove, Czechia, 500 05
Krajska nemocnice Liberec a.s. /ID# 142024
Liberec, Czechia, 46063
Univ Hosp Ostrava-Poruba /ID# 143883
Ostrava, Czechia, 708 52
France
CHRU Lille - Hôpital Claude Huriez /ID# 143915
Lille CEDEX, Hauts-de-France, France, 59045
CHU-Hopital Avicenne /ID# 143910
Bobigny, Ile-de-France, France, 93000
Gustave Roussy /ID# 143912
Villejuif, Ile-de-France, France, 94805
Institut de Cancer de l'Ouest /ID# 143914
St Herblain CEDEX, Loire-Atlantique, France, 44805
Hopital de la Timone /ID# 143911
Marseille CEDEX 05, Provence-Alpes-Cote-d Azur, France, 13385
CHU de Nice /ID# 143916
Nice CEDEX 1, Provence-Alpes-Cote-d Azur, France, 06002
Insititut de Cancerologie /ID# 143908
Angers, France, 49933
Hopital Pitie Salpetriere /ID# 143917
Paris, France, 75651
Germany
Universitaetsklinik Heidelberg /ID# 143927
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Universitaetsklinikum Leipzig /ID# 143962
Leipzig, Sachsen, Germany, 04103
Knappschaftskrankenhaus /ID# 143961
Bochum, Germany, 44791
Universitatsklinikum Tubingen /ID# 143926
Tuebingen, Germany, 72076
Hong Kong
Prince of Wales Hospital /ID# 143952
Sha Tin, Hong Kong
Ireland
Beaumont Hospital /ID# 142969
Dublin, Ireland, D09 XR63
Israel
Rabin Medical Center /ID# 143957
Petakh Tikva, Tel-Aviv, Israel, 4941492
Tel Aviv Sourasky Medical Ctr /ID# 143956
Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
Rambam Health Care Campus /ID# 143959
Haifa, Israel, 3109601
Hadassah University Hospital /ID# 143958
Jerusalem, Israel, 91120
Sheba Medical Center /ID# 143960
Ramat Gan, Israel, 5262100
Italy
AOU Citta della Salute Scienza /ID# 141801
Turin, Piemonte, Italy, 10126
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 141800
Milan, Italy, 20133
Istituto Oncologico Veneto /ID# 143821
Padova, Italy, 35128
Regina Elena National Cancer I /ID# 141795
Rome, Italy, 00144
Korea, Republic of
National Cancer Center /ID# 141845
Goyang, Gyeonggido, Korea, Republic of, 10408
Severance Hospital /ID# 141846
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
Samsung Medical Center /ID# 143887
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Cath Univ Seoul St Mary's Hosp /ID# 141844
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06591
Seoul National University Hospital /ID# 143886
Seoul, Korea, Republic of, 03080
Mexico
Hospital Zambrano Hellion /ID# 143845
San Pedro Garza García, Mexico, 66278
Netherlands
Vrije Universiteit Medisch Centrum /ID# 143889
Amsterdam, Netherlands, 1081 HV
Universitair Medisch Centrum Groningen /ID# 141408
Groningen, Netherlands, 9713 GZ
Maastricht Universitair Medisch Centrum /ID# 143585
Maastricht, Netherlands, 6229 HX
Haaglanden Medisch Centrum /ID# 141405
The Hague, Netherlands, 2512 VA
Universitair Medisch Centrum Utrecht /ID# 141406
Utrecht, Netherlands, 3584 CX
New Zealand
Canterbury District Health Boa /ID# 143861
Christchurch, New Zealand, 8011
Wellington Hospital (Capital and Coast District Health Board) /ID# 143890
Wellington, New Zealand, 6021
Portugal
CCA Braga - Hospital de Braga /ID# 141940
Braga, Portugal, 4710-243
Centro Hospitalar do Algarve /ID# 141939
Faro, Portugal, 8000-386
IPO Lisboa FG, EPE /ID# 141938
Lisboa, Portugal, 1099-023
Centro Hospitalar Lisboa Norte, EPE /ID# 141941
Lisboa, Portugal, 1649-035
Centro Hospitalar de Sao Joao, EPE /ID# 142830
Porto, Portugal, 4200-319
Russian Federation
Interregional clin.diagnostic cntr /ID# 141702
Kaliningrad, Kaliningradskaya Oblast, Russian Federation, 236016
State budgetary healthcare institution Republican Clinical Oncology Dispensary /ID# 141706
UFA, Republic Of Bashkortosta, Kirovskaya Oblast, Russian Federation, 450054
GEMC - European Medical Center /ID# 141703
Moscow, Moskovskaya Oblast, Russian Federation, 129090
NN Blokhin Russian Cancer /ID# 141707
Moscow, Moskva, Russian Federation, 115478
Scientific and Research Inst. /ID# 141701
Moscow, Moskva, Russian Federation, 125047
Federal State Treatment and rehabilitation center /ID# 141704
Moscow, Moskva, Russian Federation, 125367
Sverdlovsk Regional Oncology Center /ID# 141700
Ekaterinburg, Sverdlovskaya Oblast, Russian Federation, 620043
Singapore
National University Hospital /ID# 143933
Singapore, Singapore, 119074
National Cancer Ctr Singapore /ID# 143932
Singapore, Singapore, 169610
South Africa
University of Free State, Universitas Annex (National Hospital Grounds) /ID# 144064
Bloemfontein, Free State, South Africa, 9301
Unitas Hospital /ID# 152936
Centurion, Gauteng, South Africa, 0140
The Oncology Centre /ID# 143950
Durban, Kwazulu-Natal, South Africa, 4091
Netcare Oncology Intervent Ctr /ID# 143951
Cape Town, Western Cape, South Africa, 7460
Cape Town Oncology Trials /ID# 143948
Cape Town, Western Cape, South Africa, 7570
GVI Rondebosch Oncology Centre /ID# 143949
Cape Town, Western Cape, South Africa, 7700
Spain
Hospital Regional de Malaga /ID# 143902
Málaga, Malaga, Spain, 29009
Hosp Santa Creu i Sant Pau /ID# 143900
Barcelona, Spain, 08026
Hospital Clinic de Barcelona /ID# 143906
Barcelona, Spain, 08036
Hospital Clin Univ San Carlos /ID# 143901
Madrid, Spain, 28040
Hosp Univ 12 de Octubre /ID# 143930
Madrid, Spain, 28041
Hosp Univ Madrid Sanchinarro /ID# 143496
Madrid, Spain, 28050
Hospital General Universitario de Valencia /ID# 143903
Valencia, Spain, 46014
Switzerland
Kantonsspital Aarau /ID# 141885
Aarau, Switzerland, 5001
Ente Ospedaliero Cantonale /ID# 143936
Bellinzona, Switzerland, 6500
Inselspital, Universitaetsklinik /ID# 141886
Bern, Switzerland, 3010
University Hospital Zurich /ID# 141887
Zurich, Switzerland, 8091
Taiwan
National Taiwan Univ Hosp /ID# 143940
Taipei City, Taipei, Taiwan, 10002
Taipei Veterans General Hosp /ID# 143955
Taipei City, Taiwan, 11217
Linkou Chang Gung Memorial Ho /ID# 143941
Taoyuan City, Taiwan, 33305
United Kingdom
Guy's and St Thomas' NHS Found /ID# 142652
London, London, City Of, United Kingdom, SE1 9RT
Univ Hospitals Birmingham NHS Foundation trust /ID# 154592
Birmingham, United Kingdom, B15 2TG
Velindre Cancer Centre /ID# 141996
Cardiff, United Kingdom, CF14 2TL
Ninewells Hospital /ID# 141651
Dundee, United Kingdom, DD1 9SY
Western General Hospital /ID# 141802
Edinburgh, United Kingdom, EH4 2XU
St. James University Hospital /ID# 141653
Leeds, United Kingdom, LS9 7TF
University College Hospitals /ID# 142658
London, United Kingdom, NW1 2BU
Freeman Hospital /ID# 141999
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Royal Marsden Hospital /ID# 142827
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
AbbVie
Radiation Therapy Oncology Group
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02573324     History of Changes
Other Study ID Numbers: M13-813
2015-001166-26 ( EudraCT Number )
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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 and 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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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
Keywords provided by AbbVie:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Glioblastoma
Gliosarcoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Mitogens
Immunoconjugates
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Immunologic Factors
Physiological Effects of Drugs