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

Primary Purpose

Glioblastoma, Gliosarcoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Temozolomide
Depatuxizumab mafodotin
Radiation
Placebo for ABT-414
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring 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

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must have a clinical diagnosis of Glioblastoma (GBM).
  • Must have a confirmed Epidermal growth factor receptor amplification in tumor tissue.
  • Must have a Karnofsky Performance Status (KPS) >= 70 at assessment <= 14 days prior to randomization (N/A to the sub-study).
  • Must have recovered from effects of surgery, postoperative infection and other complications of surgery.
  • Must have adequate bone marrow, renal, and hepatic function (For the sub-study, the participant must have adequate bone marrow and renal function and have mild-to-moderate hepatic impairment).

Exclusion Criteria:

  • Multifocal, recurrent or metastatic Glioblastoma (GBM) or gliomatosis cerebri (For the sub-study, the participant can have multifocal GBM and glimatosis cerebri but can't have recurrent or metastatic GBM).
  • Prior chemo therapy or radiosensitizer for head and neck cancer.
  • Prior radiotherapy to the head or neck in overlap of radiation fields.
  • Prior therapy for glioblastoma or other invasive malignancy.
  • Prior, concomitant or planned treatment with Novo Tumor Treatment Fields (Novo-TTF), EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic therapy.

Sites / Locations

  • St. Josephs Hospital and Med Center /ID# 144149
  • Highlands Oncology Group, PA /ID# 142050
  • University of Southern California /ID# 147543
  • University of California, Los Angeles /ID# 149239
  • Sharp Memorial Hospital /ID# 148193
  • Univ California, San Francisco /ID# 145889
  • Duplicate_St. John's Health Center /ID# 148192
  • Cedars-Sinai Medical Center-West Hollywood /ID# 148472
  • Univ of Colorado Cancer Center /ID# 148194
  • Associated Neurologists of Sou /ID# 147701
  • Yale University /ID# 144170
  • Christiana Care Health Service /ID# 144127
  • Boca Raton Regional Hospital /ID# 163659
  • Holy Cross Hospital /ID# 156764
  • Baptist Hospital Miami /ID# 152451
  • Advent Health /ID# 144128
  • Moffitt Cancer Center /ID# 144130
  • Piedmont Hospital /ID# 145892
  • Emory Midtown Infectious Disease Clinic /ID# 144015
  • Northwestern University Feinberg School of Medicine /ID# 147895
  • The University of Chicago Medical Center /ID# 144158
  • NorthShore University HealthSystem /ID# 144017
  • Northwestern Medicine Cancer Center - Warrenville /ID# 148476
  • Parkview Research Ctr, Hosp /ID# 144150
  • Univ Kansas Cancer Ctr - Overl /ID# 145895
  • Maine Medical Partners Neurolo /ID# 160864
  • Tufts Medical Center /ID# 145897
  • Massachusetts General Hospital /ID# 144145
  • Dana-Farber Cancer Institute /ID# 148475
  • Wayne State University /ID# 145890
  • Henry Ford Health System /ID# 145896
  • Duplicate_St. Joseph Mercy Hospital /ID# 144143
  • Mmcorc /Id# 144146
  • Washington University-School of Medicine /ID# 144174
  • Nebraska Methodist Hospital /ID# 144140
  • University of Nebraska Medical Center /ID# 145899
  • MD Anderson Cancer Center at Cooper - Camden /ID# 145891
  • Rutgers Cancer Institute of New Jersey /ID# 148190
  • Columbia University Medical Center /ID# 144020
  • University of Rochester Medical Center /ID# 144166
  • Levine Cancer Ins, Carolina Me /ID# 144124
  • University of Cincinnati /ID# 144164
  • Duplicate_Univ Hosp Cleveland /ID# 144153
  • Cleveland Clinic Main Campus /ID# 144023
  • The Ohio State University /ID# 144016
  • University of Toledo /ID# 156763
  • Univ Oklahoma HSC /ID# 144161
  • St. Luke's Hospital /ID# 148191
  • Penn State University and Milton S. Hershey Medical Center /ID# 147525
  • University of Pennsylvania /ID# 157623
  • Thomas Jefferson University /ID# 144191
  • Fox Chase Cancer Center /ID# 145893
  • Allegheny General Hospital /ID# 144126
  • University of Pennsylvania Medical Center - Shadyside /ID# 144159
  • Medical University of South Carolina /ID# 144141
  • Austin Cancer Centers /ID# 151061
  • Baylor Sammons Cancer Center /ID# 155542
  • The University of Texas Health Science Center at Houston /ID# 144013
  • University of Texas MD Anderson Cancer Center /ID# 144018
  • Duplicate_Scott and White Medical Center /ID# 160743
  • Intermountain Medical Center /ID# 144142
  • University of Utah /ID# 144160
  • Inova Health System /ID# 152956
  • Virginia Commonwealth University Medical Center Main Hospital /ID# 149014
  • Virginia Mason Medical Center /ID# 144022
  • University of Washington /ID# 144162
  • Univ of Wisconsin Hosp/Clinics /ID# 144167
  • Froedtert Memorial Lutheran Hospital /ID# 144139
  • Sanatorio Parque /ID# 142825
  • Duplicate_Instituto Med Alex Flem /ID# 142884
  • Liverpool Hospital /ID# 144392
  • Duplicate_The Prince of Wales Hospital /ID# 144882
  • Royal North Shore Hospital /ID# 143870
  • Calvary Mater Newcastle /ID# 143860
  • Southern Medical Day Care Centre /ID# 143868
  • Princess Alexandra Hospital /ID# 143857
  • Royal Adelaide Hospital /ID# 143867
  • Calvary North Adelaide Hospita /ID# 143866
  • St Vincent's Hospital Melbourne /ID# 143858
  • Duplicate_Austin Hospital /ID# 143859
  • St John Of God Subiaco Hospital /ID# 143869
  • Medizinische Universitaet Graz /ID# 141982
  • Medizinische Universitaet Wien /ID# 141981
  • Duplicate_Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Mediz /ID# 141984
  • Kepler Universitätsklinikum GmbH - Neuromed Campus /ID# 141983
  • UCL Saint-Luc /ID# 141648
  • Grand Hopital de Charleroi /ID# 141645
  • UZ Gent /ID# 141647
  • Universitair Ziekenhuis Leuven /ID# 143872
  • Duplicate_Centre Hospitalier Jolimont /ID# 143873
  • CHU de Liege /ID# 162860
  • Duplicate_UCL Mont Godinne /ID# 141644
  • Liga Norte Riograndense Contra o Câncer /ID# 143878
  • Hospital Sao Lucas da PUCRS /ID# 143879
  • Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 143876
  • Instituto do Câncer do Estado de São Paulo - ICESP /ID# 144031
  • Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 143877
  • Duplicate_Cancer Care Manitoba /ID# 149253
  • QE II Health Sciences Centre /ID# 151600
  • Juravinski Cancer Centre /ID# 152117
  • Victoria Hospital /ID# 144184
  • Ottawa Hospital Research Institute /ID# 150120
  • Princess Margaret Cancer Centre /ID# 166277
  • Duplicate_Hospital Maisonneuve-Rosemont /ID# 149315
  • Duplicate_Jewish General Hospital /ID# 144029
  • Royal Victoria Hospital / McGill University Health Centre /ID# 144187
  • CHUM - Notre-Dame Hospital /ID# 144027
  • CHU de Quebec-Universite Laval /ID# 144189
  • CHUS - Hopital Fleurimont /ID# 149771
  • Anhui Provincial Hospital /ID# 166320
  • SanboBrain Hospital Capital Medical University /ID# 166422
  • Peking Union Medical College Hospital /ID# 157430
  • Sun Yat-Sen University Cancer Center /ID# 143919
  • Tongji Hospital Tongji Medical College of HUST /ID# 163820
  • Duplicate_Xiangya Hospital Central South University /ID# 166791
  • The First Affiliated Hospital of Soochow University /ID# 165596
  • Duplicate_Tangdu Hospital /ID# 143920
  • Duplicate_Huashan Hospital of Fudan University /ID# 159999
  • Duplicate_The Second Affiliated Hospital of ZUSM /ID# 165593
  • Beijing Tian Tan Hospital, Capital Medical University /ID# 167160
  • The First Affiliated Hospital of Fujian Medical University /ID# 159166
  • Duplicate_Shengjing Hospital of China Medical University /ID# 167016
  • Duplicate_Tianjin Med Univ General Hosp /ID# 143923
  • Hospital Pablo Tobon Uribe /ID# 143780
  • Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 147223
  • Administradora del Country_S.A-Clinica Del Country /ID# 143881
  • Oncologos del Occidente S.A /ID# 147713
  • Centro Medico Imbanaco de Cali /ID# 143882
  • Masarykuv onkologicky ustav /ID# 143884
  • Duplicate_FN Hradec Kralove /ID# 143885
  • Krajska nemocnice Liberec, a.s. /ID# 142024
  • Duplicate_Univ Hosp Ostrava-Poruba /ID# 143883
  • Fakultni Nemocnice v Motole /ID# 142023
  • AP-HM - Hopital de la Timone /ID# 143911
  • CHRU Lille - Hopital Claude Huriez /ID# 143915
  • Hopital Avicenne - APHP /ID# 143910
  • Duplicate_Gustave Roussy /ID# 143912
  • Institut de Cancérologie de l'Ouest René Gauducheau /ID# 143914
  • CHU Nice -Hopital Pasteur /ID# 143916
  • Insititut de Cancerologie /ID# 143908
  • Hopital Pitie Salpetriere /ID# 143917
  • Universitaetsklinik Heidelberg /ID# 143927
  • Universitaetsklinikum Tuebingen /ID# 143926
  • Universitaetsklinikum Leipzig /ID# 143962
  • Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH /ID# 143961
  • Prince of Wales Hospital /ID# 143952
  • Beaumont Hospital /ID# 142969
  • The Chaim Sheba Medical Center /ID# 143960
  • Tel Aviv Sourasky Medical Center /ID# 143956
  • Rambam Health Care Campus /ID# 143959
  • Gastroenterology Institute, Division of Medicine /ID# 143958
  • Rabin Medical Center /ID# 143957
  • Duplicate_Duplicate_AOU Citta della Salute Scienza /ID# 141801
  • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 141800
  • Istituto Oncologico Veneto /ID# 143821
  • Duplicate_Regina Elena National Cancer I /ID# 141795
  • National Cancer Center /ID# 141845
  • Duplicate_Yonsei University Health System, Severance hospital. /ID# 141846
  • Seoul National University Hospital /ID# 143886
  • Samsung Medical Center /ID# 143887
  • The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 141844
  • Centro Medico Zambrano Hellion /ID# 143845
  • Vrije Universiteit Medisch Centrum /ID# 143889
  • Haaglanden Medisch Centrum /ID# 141405
  • Universitair Medisch Centrum Groningen /ID# 141408
  • Maastricht Universitair Medisch Centrum /ID# 143585
  • Universitair Medisch Centrum Utrecht /ID# 141406
  • Duplicate_Canterbury District Health Boa /ID# 143861
  • Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 143890
  • CCA Braga - Hospital de Braga /ID# 141940
  • Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 141939
  • IPO Lisboa FG, EPE /ID# 141938
  • Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 141941
  • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 142830
  • Regional Clinical Hospital of Kaliningrad region /ID# 141702
  • State budgetary healthcare institution Republican Clinical Oncology Dispensary /ID# 141706
  • GEMC - European Medical Center /ID# 141703
  • Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 141707
  • National Medical Research Center for Neurosurgery n.a. N. N. Burdenko /ID# 141701
  • Federal State Treatment and Rehabilitation center /ID# 141704
  • Sverdlovsk Regional Oncology Dispensary /ID# 141700
  • National University Hospital /ID# 143933
  • National Cancer Ctr Singapore /ID# 143932
  • University of Free State, Universitas Annex (National Hospital Grounds) /ID# 144064
  • Netcare Unitas Hospital /ID# 152936
  • The Oncology Centre /ID# 143950
  • Netcare Oncology Intervent Ctr /ID# 143951
  • Rondebosch Oncology Center /ID# 143949
  • Cape Town Oncology Trials /ID# 143948
  • Hospital Regional de Malaga /ID# 143902
  • Hospital Clinic de Barcelona /ID# 143906
  • Hospital Santa Creu i Sant Pau /ID# 143900
  • Hospital Clinico Universitario San Carlos /ID# 143901
  • Hospital Universitario 12 de Octubre /ID# 143930
  • Hospital Universitario HM Sanchinarro /ID# 143496
  • Hospital General Universitario de Valencia /ID# 143903
  • Kantonsspital Aarau AG /ID# 141885
  • Universitatsspital Zurich /ID# 141887
  • Duplicate_EOC Ospedale Regionale di Bellinzona e Valli /ID# 143936
  • Inselspital, Universitätsspital Bern /ID# 141886
  • National Taiwan University Hospital /ID# 143940
  • Taipei Veterans General Hosp /ID# 143955
  • Linkou Chang Gung Memorial Hospital /ID# 143941
  • Guys and St Thomas NHS Foundation Trust /ID# 142652
  • University Hospitals Birmingham NHS Foundation Trust /ID# 154592
  • Velindre University NHS Trust /ID# 141996
  • Duplicate_NHS Tayside /ID# 141651
  • NHS Lothian /ID# 141802
  • Leeds Teaching Hospitals NHS Trust /ID# 141653
  • University College London Hospitals NHS Foundation Trust /ID# 142658
  • Duplicate_The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 141999
  • Royal Marsden Hospital /ID# 142827

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Depatuxizumab Mafodotin, Radiation and Temozolomide (TMZ)

Placebo, Radiation and TMZ

Open-Label Sub-Study: Depatuxizumab Mafodotin, Radiation and TMZ

Arm Description

Depatuxizumab mafodotin is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.

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 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.

Depatuxizumab mafodotin is given to participants with hepatic impairment on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.

Outcomes

Primary Outcome Measures

Overall Survival (OS)
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

OS for the O6-methylguaninemethlytransferese (MGMT) Unmethylated Group
Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause. Unmethylated MGMT promoter is associated with a worse prognosis in GBM
OS for the MGMT Methylated Group
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 Epidermal Growth Factor Receptor (EGFR)vIII-Mutated Tumor Subgroup
Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.
Progression-Free Survival (PFS)
PFS will be 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 (see Wen et al. J Clin Oncol. 2010 Apr 10;28(11):1963-72) or to the date of death, if disease progression does not occur.
PFS for EGFRvIII-Mutated Tumor Subgroup
PFS will be 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 or to the date of death, if disease progression does not occur.
Deterioration Free Survival in M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) Symptom Severity Score
The MDASI-BT assesses the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours. It consists of 22 symptom items and 6 interference items, each rated from 0 to 10. MDASI-BT symptom severity score is defined as average over 13 core symptom items and 9 brain tumor symptom items, with a total score of 0 to 10, with higher score indicating worse symptoms/interference. Changes in symptom severity score were classified into 3 categories: improved (≤ -1), stable (> -1 and < 1), and deteriorated (≥ 1). Deterioration is defined as satisfying the deterioration criteria (i.e., increase in symptom severity score by ≥ 1 unit) without further improvement (i.e., failing to satisfy deterioration criteria) within 8 weeks or occurrence of death.
Deterioration Free Survival in MDASI-BT Symptom Interference Score
The MDASI-BT assesses the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours. It consists of 22 symptom items and 6 interference items, each rated from 0 to 10. MDASI-BT symptom interference score is defined as an average of 6 interference items, with a total score of 0 to 10, where higher scores indicate worse interference. Changes in symptom interference score were classified into 3 categories: improved (≤ -1), stable (> -1 and < 1), and deteriorated (≥ 1). Deterioration is defined as satisfying the deterioration criteria (i.e., increase in symptom interference score by ≥ 1 unit) without further improvement (i.e., failing to satisfy deterioration criteria) within 8 weeks or occurrence of death.
Deterioration Free Survival in Neurocognitive Functioning on the Hopkins Verbal Learning Test Revised (HVLT-R) Total Recall Score
The HVLT-R consists of 3 parts. Free call has a range of 0 to 36, delayed recall has a range from 0 to 12, and delayed recognition has a range of -12 to 12. Higher scores indicating better function in all 3 parts. When scoring the HVLT-R, the 3 learning trials are combined to calculate a total recall score (range -12 to 60). Deterioration is defined as satisfying the deterioration criteria (i.e., decrease in HVLT-R total recall score by 5 units) without further improvement within 8 weeks or occurrence of death.

Full Information

First Posted
September 28, 2015
Last Updated
May 8, 2023
Sponsor
AbbVie
Collaborators
Radiation Therapy Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT02573324
Brief Title
A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification
Acronym
Intellance1
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 4, 2015 (Actual)
Primary Completion Date
April 4, 2022 (Actual)
Study Completion Date
April 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
Collaborators
Radiation Therapy Oncology Group

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, Gliosarcoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Sub-study was open-label.
Allocation
Randomized
Enrollment
691 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Depatuxizumab Mafodotin, Radiation and Temozolomide (TMZ)
Arm Type
Experimental
Arm Description
Depatuxizumab mafodotin is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
Arm Title
Placebo, Radiation and TMZ
Arm Type
Placebo Comparator
Arm Description
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 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
Arm Title
Open-Label Sub-Study: Depatuxizumab Mafodotin, Radiation and TMZ
Arm Type
Experimental
Arm Description
Depatuxizumab mafodotin is given to participants with hepatic impairment on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Depatuxizumab mafodotin is given on Day 1 and 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Description
Oral Capsule
Intervention Type
Drug
Intervention Name(s)
Depatuxizumab mafodotin
Other Intervention Name(s)
ABT-414
Intervention Description
Intravenous (IV) Infusion
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Type
Drug
Intervention Name(s)
Placebo for ABT-414
Intervention Description
IV Infusion (IV)
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.
Time Frame
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary Outcome Measure Information:
Title
OS for the O6-methylguaninemethlytransferese (MGMT) Unmethylated Group
Description
Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause. Unmethylated MGMT promoter is associated with a worse prognosis in GBM
Time Frame
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Title
OS for the MGMT Methylated Group
Description
Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.
Time Frame
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Title
OS for the Epidermal Growth Factor Receptor (EGFR)vIII-Mutated Tumor Subgroup
Description
Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.
Time Frame
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Title
Progression-Free Survival (PFS)
Description
PFS will be 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 (see Wen et al. J Clin Oncol. 2010 Apr 10;28(11):1963-72) or to the date of death, if disease progression does not occur.
Time Frame
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Title
PFS for EGFRvIII-Mutated Tumor Subgroup
Description
PFS will be 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 or to the date of death, if disease progression does not occur.
Time Frame
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Title
Deterioration Free Survival in M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) Symptom Severity Score
Description
The MDASI-BT assesses the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours. It consists of 22 symptom items and 6 interference items, each rated from 0 to 10. MDASI-BT symptom severity score is defined as average over 13 core symptom items and 9 brain tumor symptom items, with a total score of 0 to 10, with higher score indicating worse symptoms/interference. Changes in symptom severity score were classified into 3 categories: improved (≤ -1), stable (> -1 and < 1), and deteriorated (≥ 1). Deterioration is defined as satisfying the deterioration criteria (i.e., increase in symptom severity score by ≥ 1 unit) without further improvement (i.e., failing to satisfy deterioration criteria) within 8 weeks or occurrence of death.
Time Frame
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Title
Deterioration Free Survival in MDASI-BT Symptom Interference Score
Description
The MDASI-BT assesses the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours. It consists of 22 symptom items and 6 interference items, each rated from 0 to 10. MDASI-BT symptom interference score is defined as an average of 6 interference items, with a total score of 0 to 10, where higher scores indicate worse interference. Changes in symptom interference score were classified into 3 categories: improved (≤ -1), stable (> -1 and < 1), and deteriorated (≥ 1). Deterioration is defined as satisfying the deterioration criteria (i.e., increase in symptom interference score by ≥ 1 unit) without further improvement (i.e., failing to satisfy deterioration criteria) within 8 weeks or occurrence of death.
Time Frame
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Title
Deterioration Free Survival in Neurocognitive Functioning on the Hopkins Verbal Learning Test Revised (HVLT-R) Total Recall Score
Description
The HVLT-R consists of 3 parts. Free call has a range of 0 to 36, delayed recall has a range from 0 to 12, and delayed recognition has a range of -12 to 12. Higher scores indicating better function in all 3 parts. When scoring the HVLT-R, the 3 learning trials are combined to calculate a total recall score (range -12 to 60). Deterioration is defined as satisfying the deterioration criteria (i.e., decrease in HVLT-R total recall score by 5 units) without further improvement within 8 weeks or occurrence of death.
Time Frame
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must have a clinical diagnosis of glioblastoma (GBM). Must have a confirmed epidermal growth factor receptor amplification in tumor tissue. Must have a Karnofsky Performance Status (KPS) >= 70 at assessment <= 14 days prior to randomization (N/A to the sub-study). Must have recovered from effects of surgery, postoperative infection and other complications of surgery. Must have adequate bone marrow, renal, and hepatic function (For the sub-study, the participant must have adequate bone marrow and renal function and have mild-to-moderate hepatic impairment). Exclusion Criteria: Multifocal, recurrent or metastatic GBM or gliomatosis cerebri (For the sub-study, the participant can have multifocal GBM and glimatosis cerebri but can't have recurrent or metastatic GBM). Prior chemo therapy or radiosensitizer for head and neck cancer. Prior radiotherapy to the head or neck in overlap of radiation fields. Prior therapy for glioblastoma or other invasive malignancy. Prior, concomitant or planned treatment with Novo Tumor Treatment Fields (Novo-TTF), EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
St. Josephs Hospital and Med Center /ID# 144149
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Highlands Oncology Group, PA /ID# 142050
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Facility Name
University of Southern California /ID# 147543
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California, Los Angeles /ID# 149239
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Sharp Memorial Hospital /ID# 148193
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Univ California, San Francisco /ID# 145889
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-2204
Country
United States
Facility Name
Duplicate_St. John's Health Center /ID# 148192
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Cedars-Sinai Medical Center-West Hollywood /ID# 148472
City
West Hollywood
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Univ of Colorado Cancer Center /ID# 148194
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Associated Neurologists of Sou /ID# 147701
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Yale University /ID# 144170
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Christiana Care Health Service /ID# 144127
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Boca Raton Regional Hospital /ID# 163659
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Holy Cross Hospital /ID# 156764
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Baptist Hospital Miami /ID# 152451
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Advent Health /ID# 144128
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Moffitt Cancer Center /ID# 144130
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9416
Country
United States
Facility Name
Piedmont Hospital /ID# 145892
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Emory Midtown Infectious Disease Clinic /ID# 144015
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine /ID# 147895
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2927
Country
United States
Facility Name
The University of Chicago Medical Center /ID# 144158
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1443
Country
United States
Facility Name
NorthShore University HealthSystem /ID# 144017
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Northwestern Medicine Cancer Center - Warrenville /ID# 148476
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Facility Name
Parkview Research Ctr, Hosp /ID# 144150
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
Univ Kansas Cancer Ctr - Overl /ID# 145895
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205-2003
Country
United States
Facility Name
Maine Medical Partners Neurolo /ID# 160864
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Tufts Medical Center /ID# 145897
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111-1552
Country
United States
Facility Name
Massachusetts General Hospital /ID# 144145
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute /ID# 148475
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Wayne State University /ID# 145890
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-2013
Country
United States
Facility Name
Henry Ford Health System /ID# 145896
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Duplicate_St. Joseph Mercy Hospital /ID# 144143
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Mmcorc /Id# 144146
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Washington University-School of Medicine /ID# 144174
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nebraska Methodist Hospital /ID# 144140
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
University of Nebraska Medical Center /ID# 145899
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
MD Anderson Cancer Center at Cooper - Camden /ID# 145891
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey /ID# 148190
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Columbia University Medical Center /ID# 144020
City
New York
State/Province
New York
ZIP/Postal Code
10032-3729
Country
United States
Facility Name
University of Rochester Medical Center /ID# 144166
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Levine Cancer Ins, Carolina Me /ID# 144124
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
University of Cincinnati /ID# 144164
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0585
Country
United States
Facility Name
Duplicate_Univ Hosp Cleveland /ID# 144153
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Main Campus /ID# 144023
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University /ID# 144016
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Toledo /ID# 156763
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Univ Oklahoma HSC /ID# 144161
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
St. Luke's Hospital /ID# 148191
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Penn State University and Milton S. Hershey Medical Center /ID# 147525
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pennsylvania /ID# 157623
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-5502
Country
United States
Facility Name
Thomas Jefferson University /ID# 144191
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-4414
Country
United States
Facility Name
Fox Chase Cancer Center /ID# 145893
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Allegheny General Hospital /ID# 144126
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pennsylvania Medical Center - Shadyside /ID# 144159
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Medical University of South Carolina /ID# 144141
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Austin Cancer Centers /ID# 151061
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Baylor Sammons Cancer Center /ID# 155542
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
The University of Texas Health Science Center at Houston /ID# 144013
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center /ID# 144018
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Duplicate_Scott and White Medical Center /ID# 160743
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Intermountain Medical Center /ID# 144142
City
Murray
State/Province
Utah
ZIP/Postal Code
84107-5701
Country
United States
Facility Name
University of Utah /ID# 144160
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5500
Country
United States
Facility Name
Inova Health System /ID# 152956
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Virginia Commonwealth University Medical Center Main Hospital /ID# 149014
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Virginia Mason Medical Center /ID# 144022
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University of Washington /ID# 144162
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Univ of Wisconsin Hosp/Clinics /ID# 144167
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-0001
Country
United States
Facility Name
Froedtert Memorial Lutheran Hospital /ID# 144139
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3522
Country
United States
Facility Name
Sanatorio Parque /ID# 142825
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Duplicate_Instituto Med Alex Flem /ID# 142884
City
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Liverpool Hospital /ID# 144392
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Duplicate_The Prince of Wales Hospital /ID# 144882
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Royal North Shore Hospital /ID# 143870
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Calvary Mater Newcastle /ID# 143860
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Southern Medical Day Care Centre /ID# 143868
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Princess Alexandra Hospital /ID# 143857
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide Hospital /ID# 143867
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Calvary North Adelaide Hospita /ID# 143866
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Name
St Vincent's Hospital Melbourne /ID# 143858
City
Fitzroy Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Duplicate_Austin Hospital /ID# 143859
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
St John Of God Subiaco Hospital /ID# 143869
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
Medizinische Universitaet Graz /ID# 141982
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
Medizinische Universitaet Wien /ID# 141981
City
Vienna
State/Province
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Duplicate_Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Mediz /ID# 141984
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Kepler Universitätsklinikum GmbH - Neuromed Campus /ID# 141983
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
UCL Saint-Luc /ID# 141648
City
Woluwe-Saint-Lambert
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Grand Hopital de Charleroi /ID# 141645
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6000
Country
Belgium
Facility Name
UZ Gent /ID# 141647
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven /ID# 143872
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Duplicate_Centre Hospitalier Jolimont /ID# 143873
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Facility Name
CHU de Liege /ID# 162860
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Duplicate_UCL Mont Godinne /ID# 141644
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Liga Norte Riograndense Contra o Câncer /ID# 143878
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59075-740
Country
Brazil
Facility Name
Hospital Sao Lucas da PUCRS /ID# 143879
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 143876
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Instituto do Câncer do Estado de São Paulo - ICESP /ID# 144031
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 143877
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
Duplicate_Cancer Care Manitoba /ID# 149253
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
QE II Health Sciences Centre /ID# 151600
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Juravinski Cancer Centre /ID# 152117
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
Victoria Hospital /ID# 144184
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Ottawa Hospital Research Institute /ID# 150120
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Princess Margaret Cancer Centre /ID# 166277
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Duplicate_Hospital Maisonneuve-Rosemont /ID# 149315
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Duplicate_Jewish General Hospital /ID# 144029
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Royal Victoria Hospital / McGill University Health Centre /ID# 144187
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
CHUM - Notre-Dame Hospital /ID# 144027
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
CHU de Quebec-Universite Laval /ID# 144189
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
CHUS - Hopital Fleurimont /ID# 149771
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Anhui Provincial Hospital /ID# 166320
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
SanboBrain Hospital Capital Medical University /ID# 166422
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100042
Country
China
Facility Name
Peking Union Medical College Hospital /ID# 157430
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Sun Yat-Sen University Cancer Center /ID# 143919
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Tongji Hospital Tongji Medical College of HUST /ID# 163820
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Duplicate_Xiangya Hospital Central South University /ID# 166791
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
The First Affiliated Hospital of Soochow University /ID# 165596
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Name
Duplicate_Tangdu Hospital /ID# 143920
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China
Facility Name
Duplicate_Huashan Hospital of Fudan University /ID# 159999
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Duplicate_The Second Affiliated Hospital of ZUSM /ID# 165593
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Beijing Tian Tan Hospital, Capital Medical University /ID# 167160
City
Beijing
ZIP/Postal Code
100070
Country
China
Facility Name
The First Affiliated Hospital of Fujian Medical University /ID# 159166
City
Fuzhou
ZIP/Postal Code
350005
Country
China
Facility Name
Duplicate_Shengjing Hospital of China Medical University /ID# 167016
City
Shenyang
ZIP/Postal Code
110004
Country
China
Facility Name
Duplicate_Tianjin Med Univ General Hosp /ID# 143923
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Hospital Pablo Tobon Uribe /ID# 143780
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
50034
Country
Colombia
Facility Name
Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 147223
City
Monteria
State/Province
Cordoba
ZIP/Postal Code
230002
Country
Colombia
Facility Name
Administradora del Country_S.A-Clinica Del Country /ID# 143881
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Oncologos del Occidente S.A /ID# 147713
City
Pereira
State/Province
Risaralda
ZIP/Postal Code
66000
Country
Colombia
Facility Name
Centro Medico Imbanaco de Cali /ID# 143882
City
Cali
Country
Colombia
Facility Name
Masarykuv onkologicky ustav /ID# 143884
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
Duplicate_FN Hradec Kralove /ID# 143885
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Krajska nemocnice Liberec, a.s. /ID# 142024
City
Liberec
ZIP/Postal Code
460 01
Country
Czechia
Facility Name
Duplicate_Univ Hosp Ostrava-Poruba /ID# 143883
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Fakultni Nemocnice v Motole /ID# 142023
City
Praha
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
AP-HM - Hopital de la Timone /ID# 143911
City
Marseille CEDEX 05
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13385
Country
France
Facility Name
CHRU Lille - Hopital Claude Huriez /ID# 143915
City
Lille
State/Province
Hauts-de-France
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Avicenne - APHP /ID# 143910
City
Bobigny
State/Province
Ile-de-France
ZIP/Postal Code
93000
Country
France
Facility Name
Duplicate_Gustave Roussy /ID# 143912
City
Villejuif Cedex
State/Province
Ile-de-France
ZIP/Postal Code
94805
Country
France
Facility Name
Institut de Cancérologie de l'Ouest René Gauducheau /ID# 143914
City
St Herblain CEDEX
State/Province
Loire-Atlantique
ZIP/Postal Code
44805
Country
France
Facility Name
CHU Nice -Hopital Pasteur /ID# 143916
City
Nice CEDEX 1
State/Province
Provence-Alpes-Cote-d Azur
ZIP/Postal Code
06002
Country
France
Facility Name
Insititut de Cancerologie /ID# 143908
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Hopital Pitie Salpetriere /ID# 143917
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Universitaetsklinik Heidelberg /ID# 143927
City
Heidelberg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen /ID# 143926
City
Tubingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitaetsklinikum Leipzig /ID# 143962
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH /ID# 143961
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Prince of Wales Hospital /ID# 143952
City
Hong Kong
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
Beaumont Hospital /ID# 142969
City
Beaumont
State/Province
Dublin
ZIP/Postal Code
D09 XR63
Country
Ireland
Facility Name
The Chaim Sheba Medical Center /ID# 143960
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center /ID# 143956
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Rambam Health Care Campus /ID# 143959
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Gastroenterology Institute, Division of Medicine /ID# 143958
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin Medical Center /ID# 143957
City
Petakh Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Duplicate_Duplicate_AOU Citta della Salute Scienza /ID# 141801
City
Turin
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 141800
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Oncologico Veneto /ID# 143821
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Duplicate_Regina Elena National Cancer I /ID# 141795
City
Rome
ZIP/Postal Code
00144
Country
Italy
Facility Name
National Cancer Center /ID# 141845
City
Goyang
State/Province
Gyeonggido
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Duplicate_Yonsei University Health System, Severance hospital. /ID# 141846
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Seoul National University Hospital /ID# 143886
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Samsung Medical Center /ID# 143887
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 141844
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Centro Medico Zambrano Hellion /ID# 143845
City
San Pedro Garza Garcia
State/Province
Nuevo Leon
ZIP/Postal Code
66278
Country
Mexico
Facility Name
Vrije Universiteit Medisch Centrum /ID# 143889
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Haaglanden Medisch Centrum /ID# 141405
City
Den Haag
ZIP/Postal Code
2512 VA
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen /ID# 141408
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Maastricht Universitair Medisch Centrum /ID# 143585
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht /ID# 141406
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Duplicate_Canterbury District Health Boa /ID# 143861
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 143890
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
CCA Braga - Hospital de Braga /ID# 141940
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 141939
City
Faro
ZIP/Postal Code
8000-386
Country
Portugal
Facility Name
IPO Lisboa FG, EPE /ID# 141938
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 141941
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 142830
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Regional Clinical Hospital of Kaliningrad region /ID# 141702
City
Kaliningrad
State/Province
Kaliningradskaya Oblast
ZIP/Postal Code
236016
Country
Russian Federation
Facility Name
State budgetary healthcare institution Republican Clinical Oncology Dispensary /ID# 141706
City
Ufa
State/Province
Kirovskaya Oblast
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
GEMC - European Medical Center /ID# 141703
City
Moscow
State/Province
Moskovskaya Oblast
ZIP/Postal Code
129090
Country
Russian Federation
Facility Name
Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 141707
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
National Medical Research Center for Neurosurgery n.a. N. N. Burdenko /ID# 141701
City
Moscow
State/Province
Moskva
ZIP/Postal Code
125047
Country
Russian Federation
Facility Name
Federal State Treatment and Rehabilitation center /ID# 141704
City
Moscow
State/Province
Moskva
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Sverdlovsk Regional Oncology Dispensary /ID# 141700
City
Yekaterinburg
State/Province
Sverdlovskaya Oblast
ZIP/Postal Code
620043
Country
Russian Federation
Facility Name
National University Hospital /ID# 143933
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
National Cancer Ctr Singapore /ID# 143932
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
University of Free State, Universitas Annex (National Hospital Grounds) /ID# 144064
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Netcare Unitas Hospital /ID# 152936
City
Centurion
State/Province
Gauteng
ZIP/Postal Code
0140
Country
South Africa
Facility Name
The Oncology Centre /ID# 143950
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Netcare Oncology Intervent Ctr /ID# 143951
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7460
Country
South Africa
Facility Name
Rondebosch Oncology Center /ID# 143949
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Cape Town Oncology Trials /ID# 143948
City
Kraaifontein
State/Province
Western Cape
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Hospital Regional de Malaga /ID# 143902
City
Málaga
State/Province
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Clinic de Barcelona /ID# 143906
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau /ID# 143900
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Clinico Universitario San Carlos /ID# 143901
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre /ID# 143930
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro /ID# 143496
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital General Universitario de Valencia /ID# 143903
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Kantonsspital Aarau AG /ID# 141885
City
Aarau
State/Province
Aargau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Universitatsspital Zurich /ID# 141887
City
Zurich
State/Province
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Duplicate_EOC Ospedale Regionale di Bellinzona e Valli /ID# 143936
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
Inselspital, Universitätsspital Bern /ID# 141886
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
National Taiwan University Hospital /ID# 143940
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hosp /ID# 143955
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Hospital /ID# 143941
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Guys and St Thomas NHS Foundation Trust /ID# 142652
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
University Hospitals Birmingham NHS Foundation Trust /ID# 154592
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Velindre University NHS Trust /ID# 141996
City
Cardiff
ZIP/Postal Code
CF15 7QZ
Country
United Kingdom
Facility Name
Duplicate_NHS Tayside /ID# 141651
City
Dundee
ZIP/Postal Code
DD2 1UB
Country
United Kingdom
Facility Name
NHS Lothian /ID# 141802
City
Edinburgh
ZIP/Postal Code
EH3 9HE
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS Trust /ID# 141653
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust /ID# 142658
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Duplicate_The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 141999
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Royal Marsden Hospital /ID# 142827
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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, analyses plans, 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.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing 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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Citations:
PubMed Identifier
29982805
Citation
Lassman AB, van den Bent MJ, Gan HK, Reardon DA, Kumthekar P, Butowski N, Lwin Z, Mikkelsen T, Nabors LB, Papadopoulos KP, Penas-Prado M, Simes J, Wheeler H, Walbert T, Scott AM, Gomez E, Lee HJ, Roberts-Rapp L, Xiong H, Ansell PJ, Bain E, Holen KD, Maag D, Merrell R. Safety and efficacy of depatuxizumab mafodotin + temozolomide in patients with EGFR-amplified, recurrent glioblastoma: results from an international phase I multicenter trial. Neuro Oncol. 2019 Jan 1;21(1):106-114. doi: 10.1093/neuonc/noy091.
Results Reference
derived
PubMed Identifier
29077941
Citation
Gan HK, Reardon DA, Lassman AB, Merrell R, van den Bent M, Butowski N, Lwin Z, Wheeler H, Fichtel L, Scott AM, Gomez EJ, Fischer J, Mandich H, Xiong H, Lee HJ, Munasinghe WP, Roberts-Rapp LA, Ansell PJ, Holen KD, Kumthekar P. Safety, pharmacokinetics, and antitumor response of depatuxizumab mafodotin as monotherapy or in combination with temozolomide in patients with glioblastoma. Neuro Oncol. 2018 May 18;20(6):838-847. doi: 10.1093/neuonc/nox202.
Results Reference
derived
PubMed Identifier
28039367
Citation
Reardon DA, Lassman AB, van den Bent M, Kumthekar P, Merrell R, Scott AM, Fichtel L, Sulman EP, Gomez E, Fischer J, Lee HJ, Munasinghe W, Xiong H, Mandich H, Roberts-Rapp L, Ansell P, Holen KD, Gan HK. Efficacy and safety results of ABT-414 in combination with radiation and temozolomide in newly diagnosed glioblastoma. Neuro Oncol. 2017 Jul 1;19(7):965-975. doi: 10.1093/neuonc/now257.
Results Reference
derived
Links:
URL
https://www.clinicaltrialsandme.com
Description
can search for the study and find research centers participating

Learn more about this trial

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

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