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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02573324
Recruitment Status : Recruiting
First Posted : October 9, 2015
Last Update Posted : September 7, 2018
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 Multiforme Gliosarcoma Drug: Temozolomide Drug: ABT-414 Radiation: Radiation Drug: Placebo for ABT-414 Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Detailed Description:
The main study for all countries except China is closed. The sub-study of ABT-414 (number of participants being sought=12) in participants with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment is open to enrollment.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 640 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 : March 18, 2020
Estimated Study Completion Date : February 13, 2021

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.


Secondary Outcome Measures :
  1. OS for the O6-methylguaninemethlytransferese (MGMT) methylated subgroup [ 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.

  2. Number of days to deterioration in symptom severity score M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) [ Time Frame: At Screening, every 8 weeks until disease progression, and post-progression, for an average of up to 2 years. ]
    Number of days from baseline to 1 point or greater increase in MDASI-BT symptom severity score.

  3. OS for the EGFRvIII-mutated tumor subgroup [ 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.

  4. Number of days to deterioration in neurocognitive functioning on the Hopkins Verbal Learning Test Revised (HVLT-R) [ Time Frame: At Screening, every 8 weeks until disease progression, and post-progression, for an average of up to 2 years. ]
    Number of days from baseline to decline using the reliable change index (RCI) criterion based on raw scores.

  5. Progression Free Survival (PFS) [ Time Frame: At Baseline, then every 8 weeks, at follow up visits and at the final study drug visit, for an average of up to 2 years. ]
    Time to PFS is 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 (as determined by the Investigator) or to the date of death, if disease progression does not occur.

  6. Number of days to deterioration in symptom interference score (MDASI-BT) [ Time Frame: At Screening, every 8 weeks until disease progression, at post-progression, for an average of up to 2 years. ]
    Number of days from baseline to 1 point or greater increase in MDASI-BT symptom interference score.

  7. PFS for EGFRvIII-mutated tumor subgroup [ Time Frame: At Baseline, then every 8 weeks, at follow up visits and at the final study drug visit, for an average of up to 2 years. ]
    Time to PFS is 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 (as determined by the Investigator) or to the date of death, if disease progression does not occur.



Information from the National Library of Medicine

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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 gliomatosis 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


Contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

  Hide Study Locations
Locations
United States, Arizona
St. Josephs Hosp and Med Ctr /ID# 144149 Active, not recruiting
Phoenix, Arizona, United States, 85013
United States, Arkansas
Highlands Oncology Group /ID# 142050 Recruiting
Fayetteville, Arkansas, United States, 72703-4005
United States, California
Usc /Id# 147543 Recruiting
Los Angeles, California, United States, 90033
Cedars-Sinai Medical Ctr /ID# 148472 Recruiting
Los Angeles, California, United States, 90048
University of California, Los Angeles /ID# 149239 Active, not recruiting
Los Angeles, California, United States, 90095
Sharp Memorial Hospital /ID# 148193 Active, not recruiting
San Diego, California, United States, 92123
Univ California, San Francisco /ID# 145889 Active, not recruiting
San Francisco, California, United States, 94143-2204
St. John's Health Center /ID# 148192 Recruiting
Santa Monica, California, United States, 90404
United States, Colorado
Univ of Colorado Cancer Center /ID# 148194 Active, not recruiting
Aurora, Colorado, United States, 80045
United States, Connecticut
Associated Neurologists of Sou /ID# 147701 Recruiting
Fairfield, Connecticut, United States, 06824
Yale University /ID# 144170 Recruiting
New Haven, Connecticut, United States, 06510
United States, Delaware
Christiana Care Health Service /ID# 144127 Recruiting
Newark, Delaware, United States, 19713
United States, Florida
Boca Raton Regional Hospital /ID# 163659 Not yet recruiting
Boca Raton, Florida, United States, 33486
Holy Cross Hospital /ID# 156764 Not yet recruiting
Fort Lauderdale, Florida, United States, 33308
Baptist Hospital Miami /ID# 152451 Recruiting
Miami, Florida, United States, 33176
Florida Hospital /ID# 144128 Recruiting
Orlando, Florida, United States, 32803
Moffitt Cancer Center /ID# 144130 Recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Piedmont Hospital /ID# 145892 Recruiting
Atlanta, Georgia, United States, 30309
Emory University Hospital /ID# 144015 Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University /ID# 147895 Active, not recruiting
Chicago, Illinois, United States, 60611-2927
University of Chicago /ID# 144158 Recruiting
Chicago, Illinois, United States, 60637-1443
NorthShore Univ HealthSystem /ID# 144017 Active, not recruiting
Evanston, Illinois, United States, 60201
NW Medical Cancer Ctr, Geneva /ID# 151568 Not yet recruiting
Geneva, Illinois, United States, 60134
NW Medical Cancer Ctr, Warrenv /ID# 148476 Active, not recruiting
Warrenville, Illinois, United States, 60555
United States, Indiana
Parkview Research Ctr, Hosp /ID# 144150 Recruiting
Fort Wayne, Indiana, United States, 46805
United States, Kansas
Univ Kansas Cancer Ctr - Overl /ID# 145895 Active, not recruiting
Westwood, Kansas, United States, 66205-2003
United States, Maine
Maine Medical Partners Neurolo /ID# 160864 Recruiting
Scarborough, Maine, United States, 04074
United States, Massachusetts
Tufts Medical Center /ID# 145897 Recruiting
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital /ID# 144145 Recruiting
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute /ID# 148475 Not yet recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Wayne State University /ID# 145890 Recruiting
Detroit, Michigan, United States, 48201-2013
Henry Ford Health System /ID# 145896 Recruiting
Detroit, Michigan, United States, 48202
St. Joseph Mercy Hospital /ID# 144143 Recruiting
Ypsilanti, Michigan, United States, 48106
United States, Minnesota
Mmcorc /Id# 144146 Recruiting
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
Washington University-School of Medicine /ID# 144174 Active, not recruiting
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Nebraska Methodist Hospital /ID# 144140 Active, not recruiting
Omaha, Nebraska, United States, 68114
Univ Nebraska Med Ctr /ID# 145899 Active, not recruiting
Omaha, Nebraska, United States, 68198
United States, New Jersey
MD Anderson Cancer Center at Cooper /ID# 145891 Active, not recruiting
Camden, New Jersey, United States, 08103
Rutgers Cancer Institute of NJ /ID# 148190 Active, not recruiting
New Brunswick, New Jersey, United States, 08903
United States, New York
Columbia Univ Medical Center /ID# 144020 Recruiting
New York, New York, United States, 10032-3725
Univ Rochester Med Ctr /ID# 144166 Recruiting
Rochester, New York, United States, 14642
United States, North Carolina
Levine Cancer Ins, Carolina Me /ID# 144124 Recruiting
Charlotte, North Carolina, United States, 28204
United States, Ohio
University of Cincinnati /ID# 144164 Recruiting
Cincinnati, Ohio, United States, 45267-0585
Univ Hosp Cleveland /ID# 144153 Active, not recruiting
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation /ID# 144023 Recruiting
Cleveland, Ohio, United States, 44195
The Ohio State University - Columbus /ID# 144016 Recruiting
Columbus, Ohio, United States, 43210
University of Toledo /ID# 156763 Recruiting
Toledo, Ohio, United States, 43614
United States, Oklahoma
Univ Oklahoma HSC /ID# 144161 Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
St. Luke's Hospital /ID# 148191 Active, not recruiting
Bethlehem, Pennsylvania, United States, 18017
Penn State University and Milton S. Hershey Medical Center /ID# 147525 Recruiting
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania /ID# 157623 Recruiting
Philadelphia, Pennsylvania, United States, 19104-5502
Thomas Jefferson University /ID# 144191 Recruiting
Philadelphia, Pennsylvania, United States, 19107-4414
Fox Chase Cancer Center /ID# 145893 Recruiting
Philadelphia, Pennsylvania, United States, 19111
Allegheny General Hospital /ID# 144126 Recruiting
Pittsburgh, Pennsylvania, United States, 15212
UPMC - Shadyside /ID# 144159 Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Medical University of South Carolina /ID# 144141 Recruiting
Charleston, South Carolina, United States, 29425
United States, Texas
Austin Cancer Centers /ID# 151061 Recruiting
Austin, Texas, United States, 78758
Baylor Sammons Cancer Center /ID# 155542 Recruiting
Dallas, Texas, United States, 75246
Univ TX, MD Anderson /ID# 144013 Active, not recruiting
Houston, Texas, United States, 77030
Univ TX, MD Anderson /ID# 144018 Active, not recruiting
Houston, Texas, United States, 77030
Scott and White Medical Center /ID# 160743 Active, not recruiting
Temple, Texas, United States, 76508
United States, Utah
Intermountain Medical Center /ID# 144142 Active, not recruiting
Murray, Utah, United States, 84107-5701
University of Utah /ID# 144160 Active, not recruiting
Salt Lake City, Utah, United States, 84112-5500
United States, Virginia
Inova Health System /ID# 152956 Not yet recruiting
Falls Church, Virginia, United States, 22042
Virginia Commonwealth Univ /ID# 149014 Recruiting
Richmond, Virginia, United States, 23219
United States, Washington
Virginia Mason Medical Center /ID# 144022 Active, not recruiting
Seattle, Washington, United States, 98101
University of Washington /ID# 144162 Active, not recruiting
Seattle, Washington, United States, 98109
United States, Wisconsin
Univ of Wisconsin Hosp/Clinics /ID# 144167 Recruiting
Madison, Wisconsin, United States, 53792-0001
Froedtert and Medical College /ID# 144139 Recruiting
Milwaukee, Wisconsin, United States, 53226-3522
Argentina
Instituto Med Alex Flem /ID# 142884 Recruiting
Buenos Aires, Argentina, C1426ANZ
Sanatorio Parque S.A. - Grupo /ID# 142825 Not yet recruiting
Rosario, Santa FE, Argentina, 2000
Australia, New South Wales
Liverpool Hospital /ID# 144392 Recruiting
Liverpool, New South Wales, Australia, 2170
The Prince of Wales Hospital /ID# 144882 Recruiting
Randwick, New South Wales, Australia, 2031
Royal North Shore Hospital /ID# 143870 Recruiting
Saint Leonards, New South Wales, Australia, 2065
Calvary Mater Newcastle /ID# 143860 Recruiting
Waratah, New South Wales, Australia, 2298
Southern Medical Day Care Ctr /ID# 143868 Recruiting
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Princess Alexandra Hospital /ID# 143857 Recruiting
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital /ID# 143867 Recruiting
Adelaide, South Australia, Australia, 5000
Calvary North Adelaide Hospita /ID# 143866 Recruiting
Adelaide, South Australia, Australia, 5006
Australia, Victoria
St. Vincents Hosp Melbourne /ID# 143858 Recruiting
Fitzroy, Victoria, Australia, 3065
Austin Hospital /ID# 143859 Recruiting
Heidelberg, Victoria, Australia, 3084
Australia, Western Australia
St. John of God Subiaco Hosp /ID# 143869 Recruiting
Subiaco, Western Australia, Australia, 6008
Austria
AKH Wien /ID# 141981 Active, not recruiting
Vienna, Wien, Austria, 1090
LKH-Univ. Klinikum Graz /ID# 141982 Active, not recruiting
Graz, Austria, 8036
Medical University Innsbruck /ID# 141984 Active, not recruiting
Innsbruck, Austria, 6020
Kepler Universitatskliniken /ID# 141983 Active, not recruiting
Linz, Austria, 4020
Belgium
Cliniques Universitaires Saint Luc /ID# 141648 Active, not recruiting
Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
Grand Hôpital de Charleroi /ID# 141645 Active, not recruiting
Charleroi, Hainaut, Belgium, 6000
CHU de Liege /ID# 162860 Active, not recruiting
Liège, Liege, Belgium, 4000
UZ Gent /ID# 141647 Recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
Centre Hospitalier Jolimont /ID# 143873 Not yet recruiting
La Louvière, Belgium, 7100
UZ Leuven /ID# 143872 Active, not recruiting
Leuven, Belgium, 3000
UCL Mont Godinne /ID# 141644 Active, not recruiting
Yvoir, Belgium, 5530
Brazil
Liga Norte Rigrandese Contra o /ID# 143878 Recruiting
Natal, Rio Grande Do Norte, Brazil, 59062-000
Hospital Sao Lucas da PUCRS /ID# 143879 Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
Icesp /Id# 144031 Recruiting
São Paulo, Sao Paulo, Brazil, 01246-000
Inca /Id# 143877 Recruiting
Rio de Janeiro, Brazil, 20231-050
Hospital de Cancer de Barretos /ID# 143876 Recruiting
Sao Paulo, Brazil, 14784-400
Canada, Manitoba
Cancer Care Manitoba /ID# 149253 Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
Qe Ii Hsc /Id# 151600 Active, not recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Juravinski Cancer Clinic /ID# 152117 Active, not recruiting
Hamilton, Ontario, Canada, L8V 1C3
Victoria Hospital /ID# 144184 Active, not recruiting
London, Ontario, Canada, N6A 4L6
The Ottawa Hospital /ID# 150120 Active, not recruiting
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Cancer Centr /ID# 166277 Recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Hospital Maisonneuve-Rosemont /ID# 149315 Recruiting
Montreal, Quebec, Canada, H1T 2M4
McGill Univ HC /ID# 144187 Recruiting
Montreal, Quebec, Canada, H3G 1A4
Jewish General Hospital /ID# 144029 Recruiting
Montreal, Quebec, Canada, H3T 1E2
CHUM - Notre-Dame Hospital /ID# 144027 Recruiting
Montréal, Quebec, Canada, H2X 0A9
CHU de Quebec-Universite Laval /ID# 144189 Recruiting
Quebec City, Quebec, Canada, G1R 2J6
CHUS - Hopital Fleurimont /ID# 149771 Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
China, Anhui
Anhui Provincial Hospital /ID# 166320 Not yet recruiting
Hefei, Anhui, China, 230001
China, Jiangsu
1st Affil Hosp Soochow Univ /ID# 165596 Not yet recruiting
Suzhou, Jiangsu, China, 215006
China, Shanghai
Huashan Hospital affiliated to Fudan University /ID# 159999 Recruiting
Shanghai, Shanghai, China, 200040
Shanghai Changhai Hospital /ID# 164120 Not yet recruiting
Shanghai, Shanghai, China, 200433
China, Zhejiang
The Second Affiliated Hospital /ID# 165593 Not yet recruiting
Hangzhou, Zhejiang, China, 310009
China
Sanbo Brain Hospital Capital M /ID# 166422 Not yet recruiting
Beijing, China, 100042
Beijing Tian Tan Hospital /ID# 167160 Not yet recruiting
Beijing, China, 10050
Peking Union Medical College H /ID# 157430 Not yet recruiting
Beijing, China, 100730
Xiangya Hosp Central South Uni /ID# 166791 Not yet recruiting
Changsha, China, 410008
1st Affiliated Hosp Fujian Med /ID# 159166 Not yet recruiting
Fuzhou, China, 350005
Sun Yat-Sen Uni Cancer Center /ID# 143919 Not yet recruiting
Guangzhou, Guangdong, China, 510060
Shengjing Hosp China Med Univ /ID# 167016 Recruiting
Shenyang, China, 110004
Tianjin Med Univ General Hosp /ID# 143923 Not yet recruiting
Tianjin, China, 300052
Tongji Hosp Tongji Med College /ID# 163820 Recruiting
Wuhan, China, 430030
Fourth Military Medical Univ. /ID# 143920 Recruiting
Xi'an, China, 710038
Colombia
Administradora del Country_S.A-Clinica Del Country /ID# 143881 Recruiting
Bogota, Cundinamarca, Colombia, 110221
Centro Medico Imbanaco de Cali /ID# 143882 Recruiting
Cali, Colombia
Hospital Pablo Tobon Uribe /ID# 143780 Recruiting
Medellín, Colombia
Inst Med Alta Tec Onc (IMAT) /ID# 147223 Recruiting
Montería, Colombia, 230002
Oncologos de Occidente SA /ID# 147713 Recruiting
Pereira, Colombia
Czechia
Masarykuv onkologikcy ustav /ID# 143884 Active, not recruiting
Brno, Czechia, 656 53
FN Hradec Kralove /ID# 143885 Completed
Hradec Kralove, Czechia, 500 05
Krajska nemocnice Liberec a.s. /ID# 142024 Active, not recruiting
Liberec, Czechia, 46063
Univ Hosp Ostrava-Poruba /ID# 143883 Active, not recruiting
Ostrava, Czechia, 708 52
Fakultni Nemocnice v Motole /ID# 142023 Completed
Prague, Czechia, 150 00
France
CHRU Lille - Hôpital Claude Huriez /ID# 143915 Active, not recruiting
Lille CEDEX, Hauts-de-France, France, 59045
CHU-Hopital Avicenne /ID# 143910 Not yet recruiting
Bobigny, Ile-de-France, France, 93000
Institut Gustave Roussy /ID# 143912 Active, not recruiting
Villejuif, Ile-de-France, France, 94805
Institut de Cancer de l'Ouest /ID# 143914 Active, not recruiting
St Herblain CEDEX, Loire-Atlantique, France, 44805
Hopital de la Timone /ID# 143911 Active, not recruiting
Marseille CEDEX 05, Provence-Alpes-Cote-d Azur, France, 13385
CHU de Nice /ID# 143916 Active, not recruiting
Nice CEDEX 1, Provence-Alpes-Cote-d Azur, France, 06002
Insititut de Cancerologie /ID# 143908 Active, not recruiting
Angers, France, 49933
Hopital Pitie Salpetriere /ID# 143917 Active, not recruiting
Paris, France, 75651
Germany
Universitaetsklinik Heidelberg /ID# 143927 Active, not recruiting
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Universitaetsklinikum Leipzig /ID# 143962 Active, not recruiting
Leipzig, Sachsen, Germany, 04103
Knappschaftskrankenhaus /ID# 143961 Active, not recruiting
Bochum, Germany, 44791
Universitatsklinikum Tubingen /ID# 143926 Active, not recruiting
Tuebingen, Germany, 72076
Hong Kong
Prince of Wales Hospital /ID# 143952 Active, not recruiting
Sha Tin, Nt, Hong Kong, 999077
Ireland
Beaumont Hospital /ID# 142969 Active, not recruiting
Dublin, Ireland, D09 XR63
Israel
Rabin Medical Center /ID# 143957 Active, not recruiting
Petakh Tikva, Tel-Aviv, Israel, 4941492
Tel Aviv Sourasky Medical Ctr /ID# 143956 Active, not recruiting
Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
Rambam Health Care Campus /ID# 143959 Active, not recruiting
Haifa, Israel, 3109601
Hadassah University Hospital /ID# 143958 Active, not recruiting
Jerusalem, Israel, 91120
Sheba Medical Center /ID# 143960 Active, not recruiting
Ramat Gan, Israel, 5262100
Italy
AOU Citta della Salute Scienza /ID# 141801 Active, not recruiting
Turin, Piemonte, Italy, 10126
Fondazione IRCCS Istituto Neur /ID# 141800 Active, not recruiting
Milan, Italy, 20133
Istituto Oncologico Veneto /ID# 143821 Active, not recruiting
Padua, Italy, 35128
Regina Elena National Cancer I /ID# 141795 Recruiting
Rome, Italy, 00144
Korea, Republic of
National Cancer Center /ID# 141845 Recruiting
Goyang, Gyeonggido, Korea, Republic of, 10408
Severance Hospital /ID# 141846 Active, not recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
Samsung Medical Center /ID# 143887 Active, not recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Cath Univ Seoul St Mary's Hosp /ID# 141844 Active, not recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06591
Seoul National University Hospital /ID# 143886 Active, not recruiting
Seoul, Korea, Republic of, 03080
Mexico
Hospital Zambrano Hellion /ID# 143845 Recruiting
San Pedro Garza García, Mexico, 66278
Netherlands
Vrije Univ Medisch Centrum /ID# 143889 Active, not recruiting
Amsterdam, Netherlands, 1081 HV
Univ Med Center Groningen /ID# 141408 Active, not recruiting
Groningen, Netherlands, 9713 GZ
Maastricht University Med Ctr /ID# 143585 Active, not recruiting
Maastricht, Netherlands, 6229 HX
MC Haaglanden - Westeinde /ID# 141405 Active, not recruiting
The Hague, Netherlands, 2512 VA
UMC Utrecht /ID# 141406 Active, not recruiting
Utrecht, Netherlands, 3584 CX
New Zealand
Canterbury District Health Boa /ID# 143861 Recruiting
Christchurch, New Zealand, 8011
Wellington Hospital (Capital and Coast District Health Board) /ID# 143890 Recruiting
Wellington, New Zealand, 6021
Portugal
CCA Braga - Hospital de Braga /ID# 141940 Recruiting
Braga, Portugal, 4710-243
Centro Hospitalar do Algarve /ID# 141939 Recruiting
Faro, Portugal, 8000-386
IPO Lisboa FG, EPE /ID# 141938 Active, not recruiting
Lisboa, Portugal, 1099-023
Centro Hospitalar Lisboa Norte, EPE /ID# 141941 Active, not recruiting
Lisboa, Portugal, 1649-035
Centro Hospitalar de Sao Joao, EPE /ID# 142830 Active, not recruiting
Porto, Portugal, 4200-319
Russian Federation
Interregional clin.diagnostic cntr /ID# 141702 Not yet recruiting
Kaliningrad, Kaliningradskaya Oblast, Russian Federation, 236016
State budgetary healthcare institution Republican Clinical Oncology Dispensary /ID# 141706 Recruiting
UFA, Republic Of Bashkortosta, Kirovskaya Oblast, Russian Federation, 450054
GEMC - European Medical Center /ID# 141703 Recruiting
Moscow, Moskovskaya Oblast, Russian Federation, 129090
NN Blokhin Russian Cancer /ID# 141707 Active, not recruiting
Moscow, Moskva, Russian Federation, 115478
Scientific and Research Inst. /ID# 141701 Active, not recruiting
Moscow, Moskva, Russian Federation, 125047
Federal State Treatment and rehabilitation center /ID# 141704 Recruiting
Moscow, Moskva, Russian Federation, 125367
Sverdlovsk Regional Oncology Center /ID# 141700 Active, not recruiting
Ekaterinburg, Sverdlovskaya Oblast, Russian Federation, 620043
Singapore
National University Hospital /ID# 143933 Recruiting
Singapore, Singapore, 119074
National Cancer Ctr Singapore /ID# 143932 Active, not recruiting
Singapore, Singapore, 169610
South Africa
Universitas Annexe /ID# 144064 Active, not recruiting
Bloemfontein, Free State, South Africa, 9320
Unitas Hospital /ID# 152936 Not yet recruiting
Centurion, Gauteng, South Africa, 0140
The Oncology Centre /ID# 143950 Recruiting
Durban, Kwazulu-Natal, South Africa, 4091
Netcare Oncology Intervent Ctr /ID# 143951 Recruiting
Cape Town, Western Cape, South Africa, 7460
Cape Town Oncology Trials /ID# 143948 Recruiting
Cape Town, Western Cape, South Africa, 7570
GVI Rondebosch Oncology Centre /ID# 143949 Active, not recruiting
Cape Town, Western Cape, South Africa, 7700
Spain
Hospital Regional de Malaga /ID# 143902 Active, not recruiting
Málaga, Malaga, Spain, 29009
Hosp Santa Creu i Sant Pau /ID# 143900 Active, not recruiting
Barcelona, Spain, 08026
Hospital Clinic de Barcelona /ID# 143906 Active, not recruiting
Barcelona, Spain, 08036
Hospital Clin Univ San Carlos /ID# 143901 Active, not recruiting
Madrid, Spain, 28040
Hosp Univ 12 de Octubre /ID# 143930 Active, not recruiting
Madrid, Spain, 28041
Hosp Univ Madrid Sanchinarro /ID# 143496 Active, not recruiting
Madrid, Spain, 28050
Hosp General Univ de Valencia /ID# 143903 Recruiting
Valencia, Spain, 46014
Switzerland
Kantonsspital Aarau /ID# 141885 Active, not recruiting
Aarau, Switzerland, 5001
Ente Ospedaliero Cantonale /ID# 143936 Recruiting
Bellinzona, Switzerland, 6500
Inselspital, Universitaetsklin /ID# 141886 Active, not recruiting
Bern, Switzerland, 3010
University Hospital Zurich /ID# 141887 Active, not recruiting
Zurich, Switzerland, 8091
Taiwan
National Taiwan Univ Hosp /ID# 143940 Recruiting
Taipei City, Taipei, Taiwan, 10002
Taipei Veterans General Hosp /ID# 143955 Recruiting
Taipei City, Taiwan, 11217
Linkou Chang Gung Memorial Ho /ID# 143941 Active, not recruiting
Taoyuan City, Taiwan, 33305
United Kingdom
Guy's and St Thomas' NHS Found /ID# 142652 Active, not recruiting
London, London, City Of, United Kingdom, SE1 9RT
Univ Hospitals Birmingham NHS Foundation trust /ID# 154592 Active, not recruiting
Birmingham, United Kingdom, B15 2TG
Velindre Cancer Centre /ID# 141996 Active, not recruiting
Cardiff, United Kingdom, CF14 2TL
Ninewells Hospital /ID# 141651 Recruiting
Dundee, United Kingdom, DD1 9SY
Western General Hospital /ID# 141802 Active, not recruiting
Edinburgh, United Kingdom, EH4 2XU
St. James University Hospital /ID# 141653 Active, not recruiting
Leeds, United Kingdom, LS9 7TF
University College Hospitals /ID# 142658 Recruiting
London, United Kingdom, NW1 2BU
Freeman Hospital /ID# 141999 Active, not recruiting
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Royal Marsden Hospital /ID# 142827 Active, not recruiting
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
AbbVie
Radiation Therapy Oncology Group
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: September 7, 2018
Last Verified: September 2018
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

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:
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
Dacarbazine
Mitogens
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators