A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification
Intellance1
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)
2 other identifiers
interventional
691
27 countries
208
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2015
Longer than P75 for phase_3
208 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 4, 2015
CompletedFirst Submitted
Initial submission to the registry
September 28, 2015
CompletedFirst Posted
Study publicly available on registry
October 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2022
CompletedResults Posted
Study results publicly available
May 11, 2023
CompletedMay 11, 2023
May 1, 2023
7.3 years
September 28, 2015
March 23, 2023
May 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary Outcomes (8)
OS for the O6-methylguaninemethlytransferese (MGMT) Unmethylated Group
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
OS for the MGMT Methylated Group
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
OS for the Epidermal Growth Factor Receptor (EGFR)vIII-Mutated Tumor Subgroup
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Progression-Free Survival (PFS)
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
PFS for EGFRvIII-Mutated Tumor Subgroup
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
- +3 more secondary outcomes
Study Arms (3)
Depatuxizumab Mafodotin, Radiation and Temozolomide (TMZ)
EXPERIMENTALDepatuxizumab 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, Radiation and TMZ
PLACEBO COMPARATORPlacebo 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.
Open-Label Sub-Study: Depatuxizumab Mafodotin, Radiation and TMZ
EXPERIMENTALDepatuxizumab 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.
Interventions
Oral Capsule
Intravenous (IV) Infusion
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
- Radiation Therapy Oncology Groupcollaborator
Study Sites (212)
St. Josephs Hospital and Med Center /ID# 144149
Phoenix, Arizona, 85013, United States
Highlands Oncology Group, PA /ID# 142050
Springdale, Arkansas, 72762, United States
University of Southern California /ID# 147543
Los Angeles, California, 90033, United States
University of California, Los Angeles /ID# 149239
Los Angeles, California, 90095, United States
Sharp Memorial Hospital /ID# 148193
San Diego, California, 92123, United States
Univ California, San Francisco /ID# 145889
San Francisco, California, 94143-2204, United States
Duplicate_St. John's Health Center /ID# 148192
Santa Monica, California, 90404, United States
Cedars-Sinai Medical Center-West Hollywood /ID# 148472
West Hollywood, California, 90048, United States
Univ of Colorado Cancer Center /ID# 148194
Aurora, Colorado, 80045, United States
Associated Neurologists of Sou /ID# 147701
Fairfield, Connecticut, 06824, United States
Yale University /ID# 144170
New Haven, Connecticut, 06510, United States
Christiana Care Health Service /ID# 144127
Newark, Delaware, 19713, United States
Boca Raton Regional Hospital /ID# 163659
Boca Raton, Florida, 33486, United States
Holy Cross Hospital /ID# 156764
Fort Lauderdale, Florida, 33308, United States
Baptist Hospital Miami /ID# 152451
Miami, Florida, 33176, United States
Advent Health /ID# 144128
Orlando, Florida, 32803, United States
Moffitt Cancer Center /ID# 144130
Tampa, Florida, 33612-9416, United States
Piedmont Hospital /ID# 145892
Atlanta, Georgia, 30309, United States
Emory Midtown Infectious Disease Clinic /ID# 144015
Atlanta, Georgia, 30322, United States
Northwestern University Feinberg School of Medicine /ID# 147895
Chicago, Illinois, 60611-2927, United States
The University of Chicago Medical Center /ID# 144158
Chicago, Illinois, 60637-1443, United States
NorthShore University HealthSystem /ID# 144017
Evanston, Illinois, 60201, United States
Northwestern Medicine Cancer Center - Warrenville /ID# 148476
Warrenville, Illinois, 60555, United States
Parkview Research Ctr, Hosp /ID# 144150
Fort Wayne, Indiana, 46805, United States
Univ Kansas Cancer Ctr - Overl /ID# 145895
Westwood, Kansas, 66205-2003, United States
Maine Medical Partners Neurolo /ID# 160864
Scarborough, Maine, 04074, United States
Tufts Medical Center /ID# 145897
Boston, Massachusetts, 02111-1552, United States
Massachusetts General Hospital /ID# 144145
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute /ID# 148475
Boston, Massachusetts, 02215, United States
Wayne State University /ID# 145890
Detroit, Michigan, 48201-2013, United States
Henry Ford Health System /ID# 145896
Detroit, Michigan, 48202, United States
Duplicate_St. Joseph Mercy Hospital /ID# 144143
Ypsilanti, Michigan, 48197, United States
Mmcorc /Id# 144146
Saint Louis Park, Minnesota, 55416, United States
Washington University-School of Medicine /ID# 144174
St Louis, Missouri, 63110, United States
Nebraska Methodist Hospital /ID# 144140
Omaha, Nebraska, 68114, United States
University of Nebraska Medical Center /ID# 145899
Omaha, Nebraska, 68198, United States
MD Anderson Cancer Center at Cooper - Camden /ID# 145891
Camden, New Jersey, 08103, United States
Rutgers Cancer Institute of New Jersey /ID# 148190
New Brunswick, New Jersey, 08901, United States
Columbia University Medical Center /ID# 144020
New York, New York, 10032-3729, United States
University of Rochester Medical Center /ID# 144166
Rochester, New York, 14642, United States
Levine Cancer Ins, Carolina Me /ID# 144124
Charlotte, North Carolina, 28204, United States
University of Cincinnati /ID# 144164
Cincinnati, Ohio, 45267-0585, United States
Duplicate_Univ Hosp Cleveland /ID# 144153
Cleveland, Ohio, 44106, United States
Cleveland Clinic Main Campus /ID# 144023
Cleveland, Ohio, 44195, United States
The Ohio State University /ID# 144016
Columbus, Ohio, 43210, United States
University of Toledo /ID# 156763
Toledo, Ohio, 43614, United States
Univ Oklahoma HSC /ID# 144161
Oklahoma City, Oklahoma, 73104, United States
St. Luke's Hospital /ID# 148191
Bethlehem, Pennsylvania, 18017, United States
Penn State University and Milton S. Hershey Medical Center /ID# 147525
Hershey, Pennsylvania, 17033, United States
University of Pennsylvania /ID# 157623
Philadelphia, Pennsylvania, 19104-5502, United States
Thomas Jefferson University /ID# 144191
Philadelphia, Pennsylvania, 19107-4414, United States
Fox Chase Cancer Center /ID# 145893
Philadelphia, Pennsylvania, 19111, United States
Allegheny General Hospital /ID# 144126
Pittsburgh, Pennsylvania, 15212, United States
University of Pennsylvania Medical Center - Shadyside /ID# 144159
Pittsburgh, Pennsylvania, 15232, United States
Medical University of South Carolina /ID# 144141
Charleston, South Carolina, 29425, United States
Austin Cancer Centers /ID# 151061
Austin, Texas, 78758, United States
Baylor Sammons Cancer Center /ID# 155542
Dallas, Texas, 75246, United States
The University of Texas Health Science Center at Houston /ID# 144013
Houston, Texas, 77030, United States
University of Texas MD Anderson Cancer Center /ID# 144018
Houston, Texas, 77030, United States
Duplicate_Scott and White Medical Center /ID# 160743
Temple, Texas, 76508, United States
Intermountain Medical Center /ID# 144142
Murray, Utah, 84107-5701, United States
University of Utah /ID# 144160
Salt Lake City, Utah, 84112-5500, United States
Inova Health System /ID# 152956
Falls Church, Virginia, 22042, United States
Virginia Commonwealth University Medical Center Main Hospital /ID# 149014
Richmond, Virginia, 23219, United States
Virginia Mason Medical Center /ID# 144022
Seattle, Washington, 98101, United States
University of Washington /ID# 144162
Seattle, Washington, 98109, United States
Univ of Wisconsin Hosp/Clinics /ID# 144167
Madison, Wisconsin, 53792-0001, United States
Froedtert Memorial Lutheran Hospital /ID# 144139
Milwaukee, Wisconsin, 53226-3522, United States
Sanatorio Parque /ID# 142825
Rosario, Santa Fe Province, 2000, Argentina
Duplicate_Instituto Med Alex Flem /ID# 142884
Buenos Aires, 1426, Argentina
Liverpool Hospital /ID# 144392
Liverpool, New South Wales, 2170, Australia
Duplicate_The Prince of Wales Hospital /ID# 144882
Randwick, New South Wales, 2031, Australia
Royal North Shore Hospital /ID# 143870
St Leonards, New South Wales, 2065, Australia
Calvary Mater Newcastle /ID# 143860
Waratah, New South Wales, 2298, Australia
Southern Medical Day Care Centre /ID# 143868
Wollongong, New South Wales, 2500, Australia
Princess Alexandra Hospital /ID# 143857
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital /ID# 143867
Adelaide, South Australia, 5000, Australia
Calvary North Adelaide Hospita /ID# 143866
Adelaide, South Australia, 5006, Australia
St Vincent's Hospital Melbourne /ID# 143858
Fitzroy Melbourne, Victoria, 3065, Australia
Duplicate_Austin Hospital /ID# 143859
Heidelberg, Victoria, 3084, Australia
St John Of God Subiaco Hospital /ID# 143869
Subiaco, Western Australia, 6008, Australia
Medizinische Universitaet Graz /ID# 141982
Graz, Styria, 8036, Austria
Medizinische Universitaet Wien /ID# 141981
Vienna, Vienna, 1090, Austria
Duplicate_Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Mediz /ID# 141984
Innsbruck, 6020, Austria
Kepler Universitätsklinikum GmbH - Neuromed Campus /ID# 141983
Linz, 4020, Austria
UCL Saint-Luc /ID# 141648
Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium
Grand Hopital de Charleroi /ID# 141645
Charleroi, Hainaut, 6000, Belgium
UZ Gent /ID# 141647
Ghent, Oost-Vlaanderen, 9000, Belgium
Universitair Ziekenhuis Leuven /ID# 143872
Leuven, Vlaams-Brabant, 3000, Belgium
Duplicate_Centre Hospitalier Jolimont /ID# 143873
La Louvière, 7100, Belgium
CHU de Liege /ID# 162860
Liège, 4000, Belgium
Duplicate_UCL Mont Godinne /ID# 141644
Yvoir, 5530, Belgium
Liga Norte Riograndense Contra o Câncer /ID# 143878
Natal, Rio Grande do Norte, 59075-740, Brazil
Hospital Sao Lucas da PUCRS /ID# 143879
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 143876
Barretos, São Paulo, 14784-400, Brazil
Instituto do Câncer do Estado de São Paulo - ICESP /ID# 144031
São Paulo, São Paulo, 01246-000, Brazil
Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 143877
Rio de Janeiro, 20231-050, Brazil
Duplicate_Cancer Care Manitoba /ID# 149253
Winnipeg, Manitoba, R3E 0V9, Canada
QE II Health Sciences Centre /ID# 151600
Halifax, Nova Scotia, B3H 1V7, Canada
Juravinski Cancer Centre /ID# 152117
Hamilton, Ontario, L8V 1C3, Canada
Victoria Hospital /ID# 144184
London, Ontario, N6A 4L6, Canada
Ottawa Hospital Research Institute /ID# 150120
Ottawa, Ontario, K1H 8L6, Canada
Princess Margaret Cancer Centre /ID# 166277
Toronto, Ontario, M5G 2M9, Canada
Duplicate_Hospital Maisonneuve-Rosemont /ID# 149315
Montreal, Quebec, H1T 2M4, Canada
CHUM - Notre-Dame Hospital /ID# 144027
Montreal, Quebec, H2X 0A9, Canada
Duplicate_Jewish General Hospital /ID# 144029
Montreal, Quebec, H3T 1E2, Canada
Royal Victoria Hospital / McGill University Health Centre /ID# 144187
Montreal, Quebec, H4A 3J1, Canada
CHU de Quebec-Universite Laval /ID# 144189
Québec, Quebec, G1R 2J6, Canada
CHUS - Hopital Fleurimont /ID# 149771
Sherbrooke, Quebec, J1H 5N4, Canada
Anhui Provincial Hospital /ID# 166320
Hefei, Anhui, 230001, China
SanboBrain Hospital Capital Medical University /ID# 166422
Beijing, Beijing Municipality, 100042, China
Peking Union Medical College Hospital /ID# 157430
Beijing, Beijing Municipality, 100730, China
Sun Yat-Sen University Cancer Center /ID# 143919
Guangzhou, Guangdong, 510060, China
Tongji Hospital Tongji Medical College of HUST /ID# 163820
Wuhan, Hubei, 430030, China
Duplicate_Xiangya Hospital Central South University /ID# 166791
Changsha, Hunan, 410008, China
The First Affiliated Hospital of Soochow University /ID# 165596
Suzhou, Jiangsu, 215006, China
Duplicate_Tangdu Hospital /ID# 143920
Xi'an, Shaanxi, 710038, China
Duplicate_Huashan Hospital of Fudan University /ID# 159999
Shanghai, Shanghai Municipality, 200040, China
Duplicate_The Second Affiliated Hospital of ZUSM /ID# 165593
Hangzhou, Zhejiang, 310009, China
Beijing Tian Tan Hospital, Capital Medical University /ID# 167160
Beijing, 100070, China
The First Affiliated Hospital of Fujian Medical University /ID# 159166
Fuzhou, 350005, China
Duplicate_Shengjing Hospital of China Medical University /ID# 167016
Shenyang, 110004, China
Duplicate_Tianjin Med Univ General Hosp /ID# 143923
Tianjin, 300052, China
Hospital Pablo Tobon Uribe /ID# 143780
Medellín, Antioquia, 50034, Colombia
Administradora del Country_S.A-Clinica Del Country /ID# 143881
Bogota, Cundinamarca, 110221, Colombia
Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 147223
Montería, Departamento de Córdoba, 230002, Colombia
Oncologos del Occidente S.A /ID# 147713
Pereira, Risaralda Department, 66000, Colombia
Centro Medico Imbanaco de Cali /ID# 143882
Cali, Colombia
Masarykuv onkologicky ustav /ID# 143884
Brno, 656 53, Czechia
Duplicate_FN Hradec Kralove /ID# 143885
Hradec Králové, 500 05, Czechia
Krajska nemocnice Liberec, a.s. /ID# 142024
Liberec, 460 01, Czechia
Duplicate_Univ Hosp Ostrava-Poruba /ID# 143883
Ostrava, 708 52, Czechia
Fakultni Nemocnice v Motole /ID# 142023
Prague, 150 06, Czechia
AP-HM - Hopital de la Timone /ID# 143911
Marseille, Bouches-du-Rhone, 13385, France
CHRU Lille - Hopital Claude Huriez /ID# 143915
Lille, Hauts-de-France, 59037, France
Institut de Cancérologie de l'Ouest René Gauducheau /ID# 143914
Saint-Herblain, Loire-Atlantique, 44805, France
CHU Nice -Hopital Pasteur /ID# 143916
Nice, Provence-Alpes-Côte d'Azur Region, 06002, France
Insititut de Cancerologie /ID# 143908
Angers, 49933, France
Hopital Pitie Salpetriere /ID# 143917
Paris, 75013, France
Hopital Avicenne - APHP /ID# 143910
Bobigny, Île-de-France Region, 93000, France
Duplicate_Gustave Roussy /ID# 143912
Villejuif, Île-de-France Region, 94805, France
Universitaetsklinik Heidelberg /ID# 143927
Heidelberg, Baden-Wurttemberg, 69120, Germany
Universitaetsklinikum Tuebingen /ID# 143926
Tübingen, Baden-Wurttemberg, 72076, Germany
Universitaetsklinikum Leipzig /ID# 143962
Leipzig, Saxony, 04103, Germany
Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH /ID# 143961
Bochum, 44791, Germany
Prince of Wales Hospital /ID# 143952
Hong Kong, 999077, Hong Kong
Beaumont Hospital /ID# 142969
Beaumont, Dublin, D09 XR63, Ireland
The Chaim Sheba Medical Center /ID# 143960
Ramat Gan, Tel Aviv, 5265601, Israel
Tel Aviv Sourasky Medical Center /ID# 143956
Tel Aviv, Tel Aviv, 6423906, Israel
Rambam Health Care Campus /ID# 143959
Haifa, 3109601, Israel
Gastroenterology Institute, Division of Medicine /ID# 143958
Jerusalem, 91120, Israel
Rabin Medical Center /ID# 143957
Petah Tikva, 4941492, Israel
Duplicate_Duplicate_AOU Citta della Salute Scienza /ID# 141801
Turin, Piedmont, 10126, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 141800
Milan, 20133, Italy
Istituto Oncologico Veneto /ID# 143821
Padua, 35128, Italy
Duplicate_Regina Elena National Cancer I /ID# 141795
Rome, 00144, Italy
Centro Medico Zambrano Hellion /ID# 143845
San Pedro Garza García, Nuevo León, 66278, Mexico
Vrije Universiteit Medisch Centrum /ID# 143889
Amsterdam, 1081 HV, Netherlands
Universitair Medisch Centrum Groningen /ID# 141408
Groningen, 9713 GZ, Netherlands
Maastricht Universitair Medisch Centrum /ID# 143585
Maastricht, 6229 HX, Netherlands
Haaglanden Medisch Centrum /ID# 141405
The Hague, 2512 VA, Netherlands
Universitair Medisch Centrum Utrecht /ID# 141406
Utrecht, 3584 CX, Netherlands
Duplicate_Canterbury District Health Boa /ID# 143861
Christchurch, 8011, New Zealand
Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 143890
Wellington, 6021, New Zealand
CCA Braga - Hospital de Braga /ID# 141940
Braga, 4710-243, Portugal
Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 141939
Faro, 8000-386, Portugal
IPO Lisboa FG, EPE /ID# 141938
Lisbon, 1099-023, Portugal
Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 141941
Lisbon, 1649-035, Portugal
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 142830
Porto, 4200-319, Portugal
Regional Clinical Hospital of Kaliningrad region /ID# 141702
Kaliningrad, Kaliningrad Oblast, 236016, Russia
State budgetary healthcare institution Republican Clinical Oncology Dispensary /ID# 141706
Ufa, Kirov Oblast, 450054, Russia
Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 141707
Moscow, Moscow, 115478, Russia
National Medical Research Center for Neurosurgery n.a. N. N. Burdenko /ID# 141701
Moscow, Moscow, 125047, Russia
Federal State Treatment and Rehabilitation center /ID# 141704
Moscow, Moscow, 125367, Russia
GEMC - European Medical Center /ID# 141703
Moscow, Moscow Oblast, 129090, Russia
Sverdlovsk Regional Oncology Dispensary /ID# 141700
Yekaterinburg, Sverdlovsk Oblast, 620043, Russia
National University Hospital /ID# 143933
Singapore, 119074, Singapore
National Cancer Ctr Singapore /ID# 143932
Singapore, 169610, Singapore
University of Free State, Universitas Annex (National Hospital Grounds) /ID# 144064
Bloemfontein, Free State, 9301, South Africa
Netcare Unitas Hospital /ID# 152936
Centurion, Gauteng, 0140, South Africa
The Oncology Centre /ID# 143950
Durban, KwaZulu-Natal, 4091, South Africa
Netcare Oncology Intervent Ctr /ID# 143951
Cape Town, Western Cape, 7460, South Africa
Rondebosch Oncology Center /ID# 143949
Cape Town, Western Cape, 7700, South Africa
Cape Town Oncology Trials /ID# 143948
Kraaifontein, Western Cape, 7570, South Africa
National Cancer Center /ID# 141845
Goyang, Gyeonggido, 10408, South Korea
Duplicate_Yonsei University Health System, Severance hospital. /ID# 141846
Seoul, Seoul Teugbyeolsi, 03722, South Korea
Seoul National University Hospital /ID# 143886
Seoul, 03080, South Korea
Samsung Medical Center /ID# 143887
Seoul, 06351, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 141844
Seoul, 06591, South Korea
Hospital Regional de Malaga /ID# 143902
Málaga, Malaga, 29010, Spain
Hospital Clinic de Barcelona /ID# 143906
Barcelona, 08036, Spain
Hospital Santa Creu i Sant Pau /ID# 143900
Barcelona, 08041, Spain
Hospital Clinico Universitario San Carlos /ID# 143901
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre /ID# 143930
Madrid, 28041, Spain
Hospital Universitario HM Sanchinarro /ID# 143496
Madrid, 28050, Spain
Hospital General Universitario de Valencia /ID# 143903
Valencia, 46014, Spain
Kantonsspital Aarau AG /ID# 141885
Aarau, Canton of Aargau, 5001, Switzerland
Universitatsspital Zurich /ID# 141887
Zurich, Canton of Zurich, 8091, Switzerland
Duplicate_EOC Ospedale Regionale di Bellinzona e Valli /ID# 143936
Bellinzona, 6500, Switzerland
Inselspital, Universitätsspital Bern /ID# 141886
Bern, 3010, Switzerland
National Taiwan University Hospital /ID# 143940
Taipei, 100, Taiwan
Taipei Veterans General Hosp /ID# 143955
Taipei, 11217, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 143941
Taoyuan, 333, Taiwan
Guys and St Thomas NHS Foundation Trust /ID# 142652
London, London, City of, SE1 9RT, United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 154592
Birmingham, B15 2TH, United Kingdom
Velindre University NHS Trust /ID# 141996
Cardiff, CF15 7QZ, United Kingdom
Duplicate_NHS Tayside /ID# 141651
Dundee, DD2 1UB, United Kingdom
NHS Lothian /ID# 141802
Edinburgh, EH3 9HE, United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 141653
Leeds, LS9 7TF, United Kingdom
University College London Hospitals NHS Foundation Trust /ID# 142658
London, NW1 2PG, United Kingdom
Duplicate_The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 141999
Newcastle upon Tyne, NE7 7DN, United Kingdom
Royal Marsden Hospital /ID# 142827
Sutton, SM2 5PT, United Kingdom
Related Publications (3)
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.
PMID: 29982805DERIVEDGan 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.
PMID: 29077941DERIVEDReardon 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.
PMID: 28039367DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Sub-study was open-label.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
September 28, 2015
First Posted
October 9, 2015
Study Start
January 4, 2015
Primary Completion
April 4, 2022
Study Completion
April 4, 2022
Last Updated
May 11, 2023
Results First Posted
May 11, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- 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/
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.