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

This study is currently recruiting participants.
Verified November 2017 by AbbVie
Sponsor:
ClinicalTrials.gov Identifier:
NCT02573324
First Posted: October 9, 2015
Last Update Posted: November 20, 2017
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.
Collaborator:
Radiation Therapy Oncology Group
Information provided by (Responsible Party):
AbbVie
  Purpose

This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) prolongs progression free survival (PFS) and overall survival (OS) in 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 subjects with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.


Condition Intervention Phase
Glioblastoma Gliosarcoma Drug: ABT-414 Radiation: Radiation Drug: Temozolomide Drug: Placebo for ABT-414 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo Controlled Phase 2b/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)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Progression Free Survival (PFS) for Phase 2b [ 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.

  • Overall Survival (OS) for Phase 3 [ 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:
  • Progression Free Survival (PFS) for Phase 3 [ 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.

  • Overall Survival (OS) for Phase 2b [ 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.

  • 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.

  • 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.

  • Number of days to deterioration in verbal memory (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.

  • 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.

  • 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.


Estimated Enrollment: 640
Study Start Date: December 7, 2015
Estimated Study Completion Date: February 13, 2021
Estimated Primary Completion Date: March 18, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: ABT-414
intravenous infusion
Other Name: Depatuxizumab Mafodotin
Radiation: Radiation Drug: Temozolomide
oral
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.
Radiation: Radiation Drug: Temozolomide
oral
Drug: Placebo for ABT-414
intravenous infusion

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
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) performance score of 70 - 100 (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
  Contacts and Locations
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 Hospital and Medical Center /ID# 144149 Recruiting
Phoenix, Arizona, United States, 85013
United States, Arkansas
Highlands Oncology Group /ID# 142050 Recruiting
Fayetteville, Arkansas, United States, 72703
United States, California
USC Norris Comprehensive Cancer Center and Hospital /ID# 147543 Recruiting
Los Angeles, California, United States, 90033
Contact: Naveed Wagle, MD         
Cedars-Sinai Medical Center /ID# 148472 Recruiting
Los Angeles, California, United States, 90048
UCLA /Id# 149239 Recruiting
Los Angeles, California, United States, 90095-1769
Sharp Memorial Hospital /ID# 148193 Recruiting
San Diego, California, United States, 92123
University of California, San Francisco /ID# 145889 Recruiting
San Francisco, California, United States, 94143-0372
Contact: Nicholas Butowski, MD         
Providence St. John's Health Center /ID# 148192 Recruiting
Santa Monica, California, United States, 90404
Contact: Santosh Kesari, MD         
United States, Colorado
University of Colorado Cancer Center /ID# 148194 Recruiting
Aurora, Colorado, United States, 80045
United States, Connecticut
Associated Neurologists of Southern CT, P.C. /ID# 147701 Recruiting
Fairfield, Connecticut, United States, 06824
Contact: Nicholas Blondin, MD         
Yale New Haven Hospital /ID# 144170 Recruiting
New Haven, Connecticut, United States, 06520
United States, Delaware
Medical Oncology Hematology Consultants, PA /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 Recruiting
Fort Lauderdale, Florida, United States, 33308
Baptist Hospital Miami /ID# 152451 Recruiting
Miami, Florida, United States, 33176
Contact: Minesh Mehta, MD         
Florida Hospital /ID# 144128 Recruiting
Orlando, Florida, United States, 32804
Moffitt Cancer Center and Research Institute /ID# 144130 Recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Piedmont Atlanta Hospital /ID# 145892 Recruiting
Atlanta, Georgia, United States, 30318
Contact: Adam Nowlan, MD, MPH         
Emory University Hospital /ID# 144015 Recruiting
Atlanta, Georgia, United States, 30322
Contact: Ian Crocker, MD         
United States, Illinois
Northwestern University /ID# 147895 Recruiting
Chicago, Illinois, United States, 60611
Contact: Priya Kumthekar, MD         
The University of Chicago Medical Center /ID# 144158 Recruiting
Chicago, Illinois, United States, 60637
NorthShore University HealthSystem /ID# 144017 Recruiting
Evanston, Illinois, United States, 60201
Contact: Ryan Merrell, MD         
Northwestern Medical Cancer Center, Geneva /ID# 151568 Recruiting
Warrenville, Illinois, United States, 60555
Northwestern Medical Cancer Center, Warrenville /ID# 148476 Recruiting
Warrenville, Illinois, United States, 60555
United States, Indiana
Parkview Research Center, Parkview Hospital /ID# 144150 Recruiting
Fort Wayne, Indiana, United States, 46845
Contact: Brian Chang, MD         
United States, Kansas
University of Kansas Cancer Center - Overland Park /ID# 145895 Recruiting
Overland Park, Kansas, United States, 66210
United States, Maine
Maine Medical Partners Neurology /ID# 160864 Recruiting
Scarborough, Maine, United States, 04074
United States, Maryland
University of Maryland Medical Center /ID# 144165 Recruiting
Baltimore, Maryland, United States, 21201
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 Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
St. Joseph Mercy Hospital /ID# 153808 Withdrawn
Ann Arbor, Michigan, United States, 48106
St. Joseph Mercy Hospital /ID# 144143 Recruiting
Ann Arbor, Michigan, United States, 48197
Wayne State University /ID# 145890 Recruiting
Detroit, Michigan, United States, 48201
Henry Ford Hospital /ID# 145896 Recruiting
Detroit, Michigan, United States, 48202
Cancer Research Consortium of West Michigan /ID# 144021 Not yet recruiting
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Metro Minnesota Community Oncology Research Consortium /ID# 144146 Recruiting
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
Washington University School of Medicine /ID# 144174 Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Christina Tsien, MD         
United States, Nebraska
Methodist Estabrook Cancer Center /ID# 144140 Recruiting
Omaha, Nebraska, United States, 68114
University of Nebraska Medical Center /ID# 145899 Recruiting
Omaha, Nebraska, United States, 68198-7680
United States, New Jersey
MD Anderson Cancer Center at Cooper /ID# 145891 Recruiting
Camden, New Jersey, United States, 08103
Rutgers Cancer Institute of New Jersey /ID# 148190 Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Robert Aiken, MD         
United States, New York
Columbia University Medical Center /ID# 144020 Recruiting
New York, New York, United States, 10032
Contact: Andrew Lassman, MD         
University of Rochester, Cancer Center /ID# 144166 Recruiting
Rochester, New York, United States, 14642
Contact: Yuhchyau Chen, MD, PHD         
United States, North Carolina
Levine Cancer Institute, Carolinas Medical Center /ID# 144124 Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Ashley Sumrall, MD         
United States, Ohio
University of Cincinnati Medical Center /ID# 144164 Recruiting
Cincinnati, Ohio, United States, 45267
University Hospitals of Cleveland /ID# 144153 Recruiting
Cleveland, Ohio, United States, 44106
Contact: Lisa Rogers, DO         
Cleveland Clinic Foundation /ID# 144023 Recruiting
Cleveland, Ohio, United States, 44195
The Ohio State University /ID# 144016 Recruiting
Columbus, Ohio, United States, 43210
University of Toledo /ID# 156763 Recruiting
Toledo, Ohio, United States, 43614
United States, Oklahoma
University of Oklahoma Health Sciences Center /ID# 144161 Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
St. Luke's Hospital /ID# 148191 Recruiting
Bethlehem, Pennsylvania, United States, 18015
Penn State Univ and Milton S. Hershey Medical Center /ID# 147525 Recruiting
Hershey, Pennsylvania, United States, 17033
Hospital of the University of Pennsylvania Health System /ID# 157623 Recruiting
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University Hospital /ID# 144191 Recruiting
Philadelphia, Pennsylvania, United States, 19107
Fox Chase Cancer Center /ID# 145893 Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Stephanie Weiss, MD         
Allegheny General Hospital/ID#144126 Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Principal Investigator: Tulika Ranjan, MD         
UPMC - Shadyside Radiation Onc /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
Contact: David Cachia, MD         
United States, Texas
Austin Cancer Centers /ID# 151061 Recruiting
Austin, Texas, United States, 78758
Contact: Brian Vaillant, MD         
Baylor Sammons Cancer Center /ID# 154194 Withdrawn
Dallas, Texas, United States, 75246
Baylor Sammons Cancer Center /ID# 155542 Recruiting
Dallas, Texas, United States, 75246
The University of Texas - MD Anderson Cancer Center /ID# 144018 Recruiting
Houston, Texas, United States, 77030
The University of Texas Health Sciences Center at Houston /ID# 144013 Recruiting
Houston, Texas, United States, 77030
Scott and White Medical Center - Temple /ID# 160743 Recruiting
Temple, Texas, United States, 76508
United States, Utah
Intermountain Medical Center /ID# 144142 Recruiting
Murray, Utah, United States, 84157
Huntsman Cancer Institute /ID# 144160 Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Adam Cohen, MD         
United States, Virginia
Inova Health System /ID# 152956 Recruiting
Falls Church, Virginia, United States, 22042
Virginia Commonwealth University /ID# 149014 Recruiting
Richmond, Virginia, United States, 23298
United States, Washington
Virginia Mason Medical Center /ID# 144022 Recruiting
Seattle, Washington, United States, 98101
Contact: Lynne Taylor, MD         
University of Washington /ID# 144162 Recruiting
Seattle, Washington, United States, 98195
Contact: Lia Halasz, MD         
United States, Wisconsin
University of Wisconsin Hospital and Clinics /ID# 144167 Recruiting
Madison, Wisconsin, United States, 53792
Contact: H. Ian Robins, MD         
Medical College of Wisconsin at Froedtert Memorial Lutheran /ID# 144139 Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Jennifer Connelly, MD         
Argentina
Instituto Medico Alexander Fleming /ID# 142884 Recruiting
Ciudad Buenos Aires, Argentina, C1426
FLENI-Fundacion para la Lucha contra las Enfermedades /ID# 142885 Not yet recruiting
Ciudad de Buenos Aires, Argentina, C1428AQK
Sanatorio Parque S.A. - Grupo Orono /ID# 142825 Recruiting
Rosario, Argentina, 2000
Australia
Royal Adelaide Hospital /ID# 143867 Recruiting
Adelaide, Australia, 5000
Calvary North Adelaide Hospital /ID# 143866 Recruiting
Adelaide, Australia, 5006
Princess Alexandra Hospital /ID# 143857 Recruiting
Brisbane, Australia, 4102
St. Vincents Hospital Melbourne /ID# 143858 Recruiting
Fitzroy, Melbourne, Australia, VIC 3065
Austin Hospital /ID# 143859 Recruiting
Heidelberg, Australia, 3084
Liverpool Hospital /ID# 144392 Recruiting
Liverpool, Australia, 2170
The Prince of Wales Hospital /ID# 144882 Recruiting
Randwick, Australia, 2031
Royal North Shore Hospital /ID# 143870 Recruiting
St. Leonards, Australia, 2065
St. John of God Subiaco Hospital /ID# 143869 Recruiting
Subiaco, Australia, 6008
Calvary Mater Newcastle /ID# 143860 Recruiting
Warratah, Australia, 2298
Southern Medical Day Care Center /ID# 143868 Recruiting
Wollongong, Australia, 2500
Austria
Medizinische Universitat Graz /ID# 141982 Recruiting
Graz, Austria, 8036
Medical University of Innsbruck /ID# 141984 Recruiting
Innsbruck, Austria, 6020
Kepler Universitatskliniken GmbH - Neuromed Campus /ID# 141983 Recruiting
Linz, Austria, 4020
University Hospital St. Polten /ID# 141985 Withdrawn
St. Poelten, Austria, 3100
Medical University of Vienna /ID# 141981 Recruiting
Vienna, Austria, 1090
Belgium
Cliniques Universitaires Saint-Luc /ID# 141648 Recruiting
Brussels, Belgium, 1200
Grand Hopital de Charleroi /ID# 141645 Recruiting
Charleroi, Belgium, 6000
University Hospital Ghent, UZ Ghent /ID# 141647 Recruiting
Ghent, Belgium, 9000
Centre Hospitalier Jolimont /ID# 143873 Withdrawn
Haine Saint Paul, Belgium, 7100
Universitair Ziekenhuis Leuven /ID# 143872 Recruiting
Leuven, Belgium, 3000
CHU Sart Tilman /ID# 162860 Recruiting
Liege, Belgium, 4000
CHU Dinant Godinne, site Godinne /ID# 141644 Recruiting
Yvoir, Belgium, 5530
Brazil
Hospital de Cancer de Barretos, Fundacao Pio XII /ID# 143876 Recruiting
Barretos, Brazil, 14784-400
Liga Norte Rigrandese Contra o Cancer /ID# 143878 Recruiting
Natal, Brazil, 59075-740
Hospital Sao Lucas da PUCRS /ID# 143879 Recruiting
Porto Alegre, Brazil, 90610-000
Instituto Nacional de Cancer Jose Alencar Gomes da Silva /ID# 143877 Recruiting
Rio de Janeiro, Brazil, 20231-050
ICESP Instituto do Cancer do Estado de Sao Paulo /ID# 144031 Recruiting
Sao Paulo, Brazil, 01246-000
Canada
Queen Elizabeth II Health Sciences Centre /ID# 151600 Recruiting
Halifax, Canada, B3H 2Y9
Juravinski Cancer Centre /ID# 152117 Recruiting
Hamilton, Canada, L8V 5C2
London Regional Cancer Program /ID# 144184 Recruiting
London, Canada, N6A 4L6
Hopital Maisonneuver-Rosemont /ID# 149315 Recruiting
Montreal, Canada, H1T 2M4
CHUM - Notre-Dame Hospital /ID# 144027 Recruiting
Montreal, Canada, H2L 4M1
Jewish General Hospital, Sir Mortimer B. Davis /ID# 144029 Recruiting
Montreal, Canada, H3T 1E2
McGill University Health Center (MUHC) /ID# 144187 Recruiting
Montreal, Canada, H4A 3J1
The Ottawa Hospital Cancer Centre /ID# 150120 Recruiting
Ottawa, Canada, K1H 8L6
CHU de Quebec-Universite Laval /ID# 144189 Recruiting
Quebec City, Canada, G1R2J6
Centre Hospitalier universitaire de Sherbrooke (CHUS) /ID# 149771 Recruiting
Quebec, Canada, J1H 5N4
Princess Margaret Cancer Centre Radiation Oncologist /ID# 166277 Not yet recruiting
Toronto, Canada, M5G 2M9
Cancer Care Manitoba /ID# 149253 Recruiting
Winnipeg, Canada, R3E 0V9
Colombia
Clinica del Country /ID# 143881 Recruiting
Bogota, Colombia, 110221
Centro Medico Imbanaco de Cali S.A /ID# 143882 Recruiting
Cali, Colombia, 760042
Hospital Pablo Tobon Uribe /ID# 143780 Recruiting
Medellin, Antioquia, Colombia, 050034
Instituto Medico de Alta Tecnologia Oncomedica S.A. (IMAT) /ID# 147223 Recruiting
Monteria, Cordoba, Colombia, 230003
Oncologos de Occidente SA /ID# 147713 Recruiting
Pereira, Colombia, 660001
Czechia
Masarykuv onkologicky ustav /ID# 143884 Recruiting
Brno, Czechia, 656 53
Fakultni Nemocnice Hradec Kralove /ID# 143885 Completed
Hradec Kralove, Czechia, 500 05
Krajska nemocnice Liberec a.s. /ID# 142024 Recruiting
Liberec, Czechia, 46063
Fakultni nemocnice Ostrava /ID# 143883 Active, not recruiting
Ostrava, Czechia, 708 52
Fakultni Nemocnice v Motole /ID# 142023 Completed
Prague 5, Czechia, 150 06
France
Insititut de Cancerologie de l'Ouest /ID# 143908 Recruiting
Angers, France, 49055
CHU-Hopital Avicenne /ID# 143910 Recruiting
Bobigny, France, 93000
Hospices Civils de Lyon /ID# 143913 Withdrawn
Bron, France, 69677
CHRU de Lille /ID# 143915 Recruiting
Lille, France, 59037
Hopital de la Timone /ID# 143911 Recruiting
Marseille, France, 13005
CHU de Nice /ID# 143916 Recruiting
Nice, France, 06001
Groupe Hospitalier Pitie-Salpetriere /ID# 143917 Recruiting
Paris, Cedex 13, France, 75651
Insititut de Cancerologie de l'Ouest -Centre Rene Gauducheau /ID# 143914 Recruiting
Saint Herblain, France, 44800
Gustave Roussy /ID# 143912 Recruiting
Villejuif, Cedex, France, 94805
Germany
Knappschaftskrankenhaus - Universitätsklinikum /ID# 143961 Recruiting
Bochum, Germany, D-44892
Universitaetsklinikum Heidelberg Hautklinik /ID# 143927 Recruiting
Heidelberg, Germany, 69120
Universitaetsklinikum Leipzig AOR /ID# 143962 Recruiting
Leipzig, Germany, 04103
Universitaetsklinikum Tuebingen /ID# 143926 Recruiting
Tuebingen, Germany, 72076
Hong Kong
Prince of Wales Hospital /ID# 143952 Recruiting
Hong Kong SAR, Hong Kong
Ireland
Beaumont Hospital /ID# 142969 Recruiting
Dublin, Ireland, D09
Israel
Rambam Health Care Campus /ID# 143959 Recruiting
Haifa, Israel, 3525406
Hadassah University Hospital /ID# 143958 Recruiting
Jerusalem, Israel, 9112001
Rabin Medical Center /ID# 143957 Recruiting
Petah Tikva, Israel, 49100
Chaim Sheba Medical Center /ID# 143960 Recruiting
Ramat Gan, Israel, 5262100
Tel Aviv Sourasky Medical Center /ID# 143956 Recruiting
Tel Aviv, Israel, 64239
Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 141800 Recruiting
Milan, Italy, 20133
Istituto Oncologico Veneto /ID# 143821 Recruiting
Padova, Italy, 35128
Regina Elena National Cancer Institute /ID# 141795 Recruiting
Rome, Italy, 00144
A.O.U. Citta della Salute e della Scienza di Turin /ID# 141801 Recruiting
Turin, Italy, 10126
Japan
Kumamoto University Hospital /ID# 153021 Withdrawn
Kumamoto-shi, Kumamoto, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases /ID# 152740 Withdrawn
Osaka, Japan
Hokkaido University Hospital /ID# 152931 Withdrawn
Sapporo, Japan
Dokkyo Medical University Hospital /ID# 152741 Withdrawn
Shimotsuga-gun, Japan
National Cancer Center Hospital /ID# 152630 Withdrawn
Tokyo, Japan
Korea, Republic of
National Cancer Center /ID# 141845 Recruiting
Gyeonggi-do, Korea, Republic of, 10408
Seoul National University Hospital /ID# 143886 Recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital /ID# 141846 Recruiting
Seoul, Korea, Republic of, 03722
Samsung Medical Center /ID# 143887 Recruiting
Seoul, Korea, Republic of, 06351
The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 141844 Recruiting
Seoul, Korea, Republic of, 06591
Mexico
Instituto Jalisciense de Investigacion Clinica, SA de CV /ID# 143888 Withdrawn
Guadalajara, Jalisco, Mexico, 44280
Hospital Zambrano Hellion /ID# 143845 Recruiting
Monterrey, N.L., Mexico, C.P. 66278
Instituto Nacional del Cancer (INCAN) /ID# 143843 Withdrawn
Tlapan, Mexico, C.P. 14080
Netherlands
Vrije Universiteit Medical Center /ID# 143889 Recruiting
Amsterdam, Netherlands, 1081 HV
University Medical Center Groningen /ID# 141408 Recruiting
Groningen, Netherlands, 9713 GZ
MC Haaglanden - Westeinde /ID# 141405 Recruiting
Leidschendam, Netherlands, 2262 BA
Maastricht University Medical Center /ID# 143585 Recruiting
Maastricht, Netherlands, 6229 HX
UMC Utrecht /ID# 141406 Recruiting
Utrecht, Netherlands, 3584 CX
New Zealand
Canterbury District Health Board /ID# 143861 Recruiting
Christchurch, Canterbury, New Zealand, 8140
Wellington Blood & Cancer Centre /ID# 143890 Recruiting
Wellington, New Zealand, 6021
Portugal
Hospital of Braga /ID# 141940 Recruiting
Braga, Portugal, 4710-243
Centro Hospitalar do Algarve, EPE /ID# 141939 Recruiting
Faro, Portugal, 8000-386
Instituto Portugues de Oncologia Lisboa Francisco Gentil EPE /ID# 141938 Recruiting
Lisbon, Portugal, 1099-023
Centro Hospitalar de Lisbon Norte, EPE /ID# 141941 Recruiting
Lisbon, Portugal, 1649-035
Centro Hospitalar de Sao Joao, E.P.E.(CHSJ-HSJ) /ID# 142830 Recruiting
Porto, Portugal, 4200-319
Russian Federation
Interregional clinical diagnostic center /ID# 141702 Withdrawn
Kaliningrad, Russian Federation, 236016
Russian NN Blokhin Russian Cancer Research Center /ID# 141707 Recruiting
Moscow, Russian Federation, 115478
Scientific and Research Institute of eurosugery NA Burdenko /ID# 141701 Recruiting
Moscow, Russian Federation, 125047
Federal State Treatment and Rehabilitation Centre /ID# 141704 Withdrawn
Moscow, Russian Federation, 125367
GEMC - European Medical Center /ID# 141703 Recruiting
Moscow, Russian Federation, 129090
Republican Clinical Oncology Center /ID# 141706 Recruiting
Ufa, Republic Of Bashkortostan, Russian Federation, 450054
Sverdlovskiy Oncological Dispesary /ID# 141700 Recruiting
Yekaterinburg, Russian Federation, 620036
Singapore
National University Hospital /ID# 143933 Recruiting
Singapore, Singapore, 119228
National Cancer Centre Singapore /ID# 143932 Recruiting
Singapore, Singapore, 169610
South Africa
Universitas Annexe /ID# 144064 Recruiting
Bloemfontein, South Africa, 9301
Netcare Oncology Interventional Centre /ID# 143951 Recruiting
Cape Town, South Africa, 7460
The Oncology Centre /ID# 143950 Recruiting
Durban, South Africa, 4001
Cape Town Oncology Trials /ID# 143948 Recruiting
Kraaifontein, South Africa, 7570
Unitas Hospital /ID# 152936 Withdrawn
Lyttelton,Pretoria, South Africa, 1081
GVI Rondebosch Oncology Centre /ID# 143949 Recruiting
Rondebosch, Cape Town, South Africa, 7700
Spain
Hospital de Barcelona /ID# 143906 Recruiting
Barcelona, Catalunya, Spain, 08036
Hospital de la Santa Creu i Sant Pau /ID# 143900 Recruiting
Barcelona, Spain, 8041
Hospital Universitario Clinico San Carlos /ID# 143901 Recruiting
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre /ID# 143930 Recruiting
Madrid, Spain, 28041
Hospital Universitario Madrid Sanchinarro /ID# 143496 Recruiting
Madrid, Spain, 28050
Hospital Regional Universitario de Malaga /ID# 143902 Recruiting
Malaga, Spain, 29010
Hospital General Universitario de Valencia /ID# 143903 Recruiting
Valencia, Spain, 46014
Switzerland
Kantonsspital Aarau /ID# 141885 Recruiting
Aarau, Switzerland, 5001
Ente Ospedaliero Cantonale /ID# 143936 Recruiting
Bellinzona, Switzerland, CH 6500
Inselspital Bern /ID# 141886 Recruiting
Bern, Switzerland, 3010
University Hospital Zurich /ID# 141887 Recruiting
Zurich, Switzerland, 8091
Taiwan
National Taiwan University Hospital /ID# 143940 Recruiting
Taipei City, Taiwan, 10002
Taipei Veterans General Hospital /ID# 143955 Recruiting
Taipei City, Taiwan, 11217
LinKuo Chang Gung Memorial Hospital /ID# 143941 Recruiting
Taoyuan County, Taiwan, 333
United Kingdom
University Hospitals Birmingham NHS /ID# 154592 Recruiting
Birmingham, United Kingdom, B15 2WB
Velindre Cancer Centre, Velindre NHS Trust /ID# 141996 Recruiting
Cardiff, South Wales, United Kingdom, CF14 2TL
Northampton General Hospital /ID# 141995 Withdrawn
Cliftonville, Northampton, United Kingdom, NN1 4BD
Ninewells Hospital /ID# 141651 Recruiting
Dundee, United Kingdom, DD1 9SY
Western General Hospital /ID# 141802 Recruiting
Edinburgh, United Kingdom, EH4 2XU
St. James University Hospital /ID# 141653 Recruiting
Leeds, United Kingdom, LS9 7TF
University College London Hospitals /ID# 142658 Recruiting
London, United Kingdom, NW1 2PG
Guy's and St Thomas' NHS Foundation Trust /ID# 142652 Recruiting
London, United Kingdom, SE1 7EH
Freeman Hospital /ID# 141999 Recruiting
Newcastle upon Tyne, United Kingdom, NE7 7DN
Royal Marsden Hospital /ID# 142827 Recruiting
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
AbbVie
Radiation Therapy Oncology Group
Investigators
Study Director: Earle Bain, MD AbbVie
  More Information

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02573324     History of Changes
Other Study ID Numbers: M13-813
2015-001166-26 ( EudraCT Number )
First Submitted: September 28, 2015
First Posted: October 9, 2015
Last Update Posted: November 20, 2017
Last Verified: November 2017

Keywords provided by AbbVie:
Newly Diagnosed Glioblastoma
Brain Cancer
Temozolomide
EGFR Amplified
Radiology Therapy Oncology Group
ABT-414
EGFRvIII
Antibody Drug Conjugate
Epithelial Growth Factor Receptor
Brain Tumor Group
First Line Therapy
Brain Tumor

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