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

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ClinicalTrials.gov Identifier: NCT02573324
Recruitment Status : Recruiting
First Posted : October 9, 2015
Last Update Posted : January 17, 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 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 ...

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.



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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 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


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

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Locations
United States, Arizona
St. Josephs Hosp and Med Ctr Recruiting
Phoenix, Arizona, United States, 85013
United States, Arkansas
Highlands Oncology Group Recruiting
Fayetteville, Arkansas, United States, 72703
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USC Recruiting
Los Angeles, California, United States, 90033
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Los Angeles, California, United States, 90048
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Los Angeles, California, United States, 90095
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
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San Francisco, California, United States, 94143
St. John's Health Center Recruiting
Santa Monica, California, United States, 90404
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Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
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Associated Neurologists of Sou Recruiting
Fairfield, Connecticut, United States, 06824
Yale University Recruiting
New Haven, Connecticut, United States, 06510
United States, Delaware
Christiana Care Health Service Recruiting
Newark, Delaware, United States, 19713
United States, Florida
Boca Raton Regional Hospital Not yet recruiting
Boca Raton, Florida, United States, 33486
Holy Cross Hospital Not yet recruiting
Fort Lauderdale, Florida, United States, 33308
Baptist Hospital Miami Recruiting
Miami, Florida, United States, 33176
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
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Piedmont Hospital Recruiting
Atlanta, Georgia, United States, 30309
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
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Northwestern University Recruiting
Chicago, Illinois, United States, 60611
University of Chicago Recruiting
Chicago, Illinois, United States, 60637-1443
NorthShore Univ HealthSystem Recruiting
Evanston, Illinois, United States, 60201
NW Medical Cancer Ctr, Geneva Not yet recruiting
Geneva, Illinois, United States, 60134
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Warrenville, Illinois, United States, 60555
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Parkview Research Ctr, Hosp Recruiting
Fort Wayne, Indiana, United States, 46805
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Univ Kansas Cancer Ctr - Overl Recruiting
Westwood, Kansas, United States, 66205-2003
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Maine Medical Partners Neurolo Recruiting
Scarborough, Maine, United States, 04074
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02215
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Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
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Detroit, Michigan, United States, 48202
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Ypsilanti, Michigan, United States, 48106
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MMCORC Recruiting
Saint Louis Park, Minnesota, United States, 55416
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Washington Univ School Med Recruiting
Saint Louis, Missouri, United States, 63110
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Nebraska Methodist Hospital Recruiting
Omaha, Nebraska, United States, 68114
Univ Nebraska Med Ctr Recruiting
Omaha, Nebraska, United States, 68198
United States, New Jersey
Rutgers Cancer Institute of NJ Recruiting
New Brunswick, New Jersey, United States, 08903
Cooper Health System Recruiting
Voorhees, New Jersey, United States, 08043
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Columbia University Medical Center-OB/GYN Department Recruiting
New York, New York, United States, 10032
Univ Rochester Med Ctr Recruiting
Rochester, New York, United States, 14642
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Levine Cancer Ins, Carolina Me Recruiting
Charlotte, North Carolina, United States, 28204
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University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Univ Hosp Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
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Toledo, Ohio, United States, 43614
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Univ Oklahoma HSC Recruiting
Oklahoma City, Oklahoma, United States, 73104
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St. Luke's Hospital Recruiting
Bethlehem, Pennsylvania, United States, 18017
Penn State University and Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson Obsterics and Gynecology Recruiting
Philadelphia, Pennsylvania, United States, 19107-4414
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
UPMC - Shadyside Radiation Onc Recruiting
Pittsburgh, Pennsylvania, United States, 15232
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Med Univ of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
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Austin Cancer Centers Recruiting
Austin, Texas, United States, 78758
Baylor Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Univ TX, MD Anderson Recruiting
Houston, Texas, United States, 77030
Scott and White Medical Center Recruiting
Temple, Texas, United States, 76508
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Intermountain Medical Center Recruiting
Murray, Utah, United States, 84107-5701
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112-5500
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Inova Health System Not yet recruiting
Falls Church, Virginia, United States, 22042
Virginia Commonwealth Univ Recruiting
Richmond, Virginia, United States, 23219
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Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
University of Washington Recruiting
Seattle, Washington, United States, 98109
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Univ of Wisconsin Hosp/Clinics Recruiting
Madison, Wisconsin, United States, 53792
Froedtert and Medical College Recruiting
Milwaukee, Wisconsin, United States, 53226-3522
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Instituto Med Alex Flem Recruiting
Buenos Aires, Argentina, C1426ANZ
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Rosario, Argentina, 2000
Australia, New South Wales
Liverpool Hospital Recruiting
Liverpool, New South Wales, Australia, 2170
The Prince of Wales Hospital Recruiting
Randwick, New South Wales, Australia, 2031
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Saint Leonards, New South Wales, Australia, 2065
Calvary Mater Newcastle Recruiting
Waratah, New South Wales, Australia, 2298
Southern Medical Day Care Ctr Recruiting
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Calvary North Adelaide Hospita Recruiting
Adelaide, South Australia, Australia, 5006
Australia, Victoria
St. Vincents Hosp Melbourne Recruiting
Fitzroy, Victoria, Australia, 3065
Austin Hospital Recruiting
Heidelberg, Victoria, Australia, 3084
Australia, Western Australia
St. John of God Subiaco Hosp Recruiting
Subiaco, Western Australia, Australia, 6008
Austria
LKH-Univ. Klinikum Graz Recruiting
Graz, Austria, 8036
Medical University Innsbruck Recruiting
Innsbruck, Austria, 6020
Kepler Universitatskliniken Recruiting
Linz, Austria, 4020
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Belgium
CHU Liège Sart Tilman Recruiting
Liège, Liege, Belgium, 4000
Cliniques Univ. Saint Luc Recruiting
Brussels, Belgium, 1200
Grand Hopital de Charleroi Recruiting
Charleroi, Belgium, 6000
UZ Ghent Recruiting
Ghent, Belgium, 9000
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Leuven, Belgium, 3000
UCL Mont Godinne Recruiting
Yvoir, Belgium, 5530
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Liga Norte Rigrandese Contra o Recruiting
Natal, Rio Grande Do Norte, Brazil, 59062-300
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Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
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Rio de Janeiro, Brazil, 20231-050
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Sao Paulo, Brazil, 01246-000
Hospital de Cancer de Barretos Recruiting
Sao Paulo, Brazil, 14784-400
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Cancer Care Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
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Qe Ii Hsc Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
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Juravinski Cancer Clinic Recruiting
Hamilton, Ontario, Canada, L8V 1C3
Victoria Hospital Recruiting
London, Ontario, Canada, N6A 4G5
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Cancer Centr Recruiting
Toronto, Ontario, Canada, M5G 2M9
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Hospital Maisonneuve-Rosemont Recruiting
Montreal, Quebec, Canada, H1T 2M4
CHUM - Notre-Dame Hospital Recruiting
Montreal, Quebec, Canada, H2L 4M1
McGill Univ HC Recruiting
Montreal, Quebec, Canada, H3G 1A4
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
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Quebec City, Quebec, Canada, G1R 2J6
CRC-CHUS Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
China, Anhui
Shanghai Changhai Hospital Not yet recruiting
Shanghai, Anhui, China, 200433
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Huashan Hospital of Fudan Univ Recruiting
Shanghai, Shanghai, China, 200040
China
Beijing Shijitan Hospital Not yet recruiting
Beijing, China, 100038
Peking Union Medical College H Not yet recruiting
Beijing, China, 100730
1st Affiliated Hosp Fujian Med Not yet recruiting
Fuzhou, China, 350005
Tongji Hosp Tongji Med College Not yet recruiting
Wuhan, China, 430030
Fourth Military Medical Univ. Recruiting
Xi'an, China, 710038
Colombia
Administradora de Country S.A_Clinica del Country Recruiting
Bogota, Cundinamarca, Colombia, 110221
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Cali, Colombia
Hospital Pablo Tobon Uribe Recruiting
Medellín, Colombia
Inst Med Alta Tec Onc (IMAT) Recruiting
Monteria, Colombia
Oncologos de Occidente SA Recruiting
Pereira, Colombia
Czechia
Masarykuv onkologikcy ustav Completed
Brno, Czechia, 656 53
FN Hradec Kralove Completed
Hradec Kralove, Czechia, 500 05
Krajska nemocnice Liberec a.s. Recruiting
Liberec, Czechia, 46063
Univ Hosp Ostrava-Poruba Active, not recruiting
Ostrava, Czechia, 708 52
Fakultni Nemocnice v Motole Completed
Prague, Czechia, 150 00
France
Institut Gustave Roussy Recruiting
Villejuif, Ile-de-France, France, 94805
Institut de Cancer de l'Ouest Recruiting
St Herblain CEDEX, Loire-Atlantique, France, 44805
CHRU de Lille, Hopital Roger Salengro Recruiting
Lille CEDEX, Nord-Pas-de-Calais, France, 59037
Hopital de la Timone Recruiting
Marseille CEDEX 05, Provence-Alpes-Cote-d Azur, France, 13385
Insititut de Cancerologie Recruiting
Angers, France, 49933
CHU de Nice Recruiting
Nice, France, 06001
Hopital Pitie Salpetriere Recruiting
Paris, France, 75651
Germany
Universitaetsklinikum Leipzig Recruiting
Leipzig, Sachsen, Germany, 04103
Knappschaftskrankenhaus Recruiting
Bochum, Germany, 44791
Universitaetsklinik Heidelberg Recruiting
Heidelberg, Germany, 69120
Universitatsklinikum Tubingen Recruiting
Tuebingen, Germany, 72076
Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong, 999077
Ireland
Beaumont Hospital Recruiting
Dublin, Ireland, D09 XR63
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel, 3109601
Hadassah University Hospital Recruiting
Jerusalem, Israel, 91120
Rabin Medical Center Recruiting
Petah Tikva, Israel, 49100
Sheba Medical Center Recruiting
Ramat Gan, Israel, 5262100
Tel Aviv Sourasky Medical Ctr Recruiting
Tel Aviv, Israel, 64239
Italy
Fondazione IRCCS Istituto Neur Recruiting
Milan, Italy, 20133
Istituto Oncologico Veneto Recruiting
Padua, Italy, 35128
Regina Elena National Cancer I Recruiting
Rome, Italy, 00144
AOU Citta della Salute Scienza Recruiting
Torino, Italy, 10126
Korea, Republic of
National Cancer Center Recruiting
Goyang, Gyeonggido, Korea, Republic of, 10408
Seoul National University Hospital Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080
Severance Hospital Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
Cath Univ Seoul St Mary's Hosp Recruiting
Seoul, Korea, Republic of, 06591
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Mexico
Hospital Zambrano Hellion Recruiting
San Pedro Garza García, Mexico, 66278
Netherlands
Vrije Univ Medisch Centrum Recruiting
Amsterdam, Netherlands, 1081 HV
Univ Med Center Groningen Recruiting
Groningen, Netherlands, 9713 GZ
Maastricht University Med Ctr Recruiting
Maastricht, Netherlands, 6229 HX
MC Haaglanden - Westeinde Recruiting
The Hague, Netherlands, 2512 VA
UMC Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
New Zealand
Canterbury District Health Boa Recruiting
Christchurch, New Zealand, 8011
Wellington Hospital Recruiting
Wellington, New Zealand, 6021
Portugal
Hospital of Braga Recruiting
Braga, Portugal, 4710-243
Centro Hospitalar do Algarve Recruiting
Faro, Portugal, 8000-386
IPO Lisboa FG, EPE Recruiting
Lisboa, Portugal, 1099-023
Centro Hospitalar Lisboa Norte, EPE Recruiting
Lisboa, Portugal, 1649-035
Centro Hospitalar de Sao Joao, EPE Recruiting
Porto, Portugal, 4200-319
Russian Federation
State budgetary healthcare institution Republican Clinical Oncology Dispensary Recruiting
UFA, Kirovskaya Oblast, Russian Federation, 450054
Russian N.N.Blokhin Cancer Research Center Recruiting
Moscow, Moskva, Russian Federation, 115478
Federal State Autonomic Institution "Scientific and Research institute of neur Recruiting
Moscow, Moskva, Russian Federation, 125047
Sverdlovsk Regional Oncology Center Recruiting
Ekaterinburg, Sverdlovskaya Oblast, Russian Federation, 620043
Moscow Reg Res Clin Inst Recruiting
Moscow, Russian Federation, 129110
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119074
National Cancer Ctr Singapore Recruiting
Singapore, Singapore, 169610
South Africa
Universitas Annexe Recruiting
Bloemfontein, Free State, South Africa, 9320
The Oncology Centre Recruiting
Durban, Kwazulu-Natal, South Africa, 4091
Netcare Oncology Intervent Ctr Recruiting
Cape Town, Western Cape, South Africa, 7460
Cape Town Oncology Trials Recruiting
Cape Town, Western Cape, South Africa, 7570
GVI Rondebosch Oncology Centre Recruiting
Cape Town, Western Cape, South Africa, 7700
Spain
Hosp Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08026
Hospital de Barcelona Recruiting
Barcelona, Spain, 08036
Hospital Clin Univ San Carlos Recruiting
Madrid, Spain, 28040
Hosp Univ 12 de Octubre Recruiting
Madrid, Spain, 28041
Hosp Univ Madrid Sanchinarro Recruiting
Madrid, Spain, 28050
Hospital Reg Uni de Malaga Recruiting
Malaga, Spain, 29009
Hosp General Univ de Valencia Recruiting
Valencia, Spain, 46014
Switzerland
Kantonsspital Aarau Recruiting
Aarau, Switzerland, 5001
Ente Ospedaliero Cantonale Recruiting
Bellinzona, Switzerland, 6500
Inselspital, Universitaetsklin Recruiting
Bern, Switzerland, 3010
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Taiwan
National Taiwan Univ Hosp Recruiting
Taipei City, Taiwan, 10002
Taipei Veterans General Hosp Recruiting
Taipei City, Taiwan, 11217
Linkou Chang Gung Memorial Ho Recruiting
Taoyuan City, Taiwan, 33305
United Kingdom
Univ Hospitals Birmingham NHS Recruiting
Birmingham, United Kingdom, B15 2TH
Velindre Cancer Centre Recruiting
Cardiff, United Kingdom, CF14 2TL
Ninewells Hospital Recruiting
Dundee, United Kingdom, DD1 9SY
Western General Hospital Recruiting
Edinburgh, United Kingdom, EH4 2XU
St. James University Hospital Recruiting
Leeds, United Kingdom, LS9 7TF
University College Hospitals Recruiting
London, United Kingdom, NW1 2BU
Guy's and St Thomas' NHS Found Recruiting
London, United Kingdom, SE1 9RT
Freeman Hospital Recruiting
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Royal Marsden Hospital 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: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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