AzTrials
AzTrials

GlioblastomaPhase 3Intellance1NCT02573324

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

A Phase 3 study testing Temozolomide, Depatuxizumab mafodotin and Radiation in people with Glioblastoma and Gliosarcoma, run by AbbVie at 212 sites in 28 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Glioblastoma, Gliosarcoma
What is being tested?
Temozolomide, Depatuxizumab mafodotin and Radiation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
691 participants
Where
212 sitesin 28 countries
Study dates
4 Jan 2015to 4 Apr 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

212 sites in 28 countries.

212 sites in 28 countries

United States68 sites

  • Piedmont Hospital /ID# 145892

    Atlanta, Georgia, 30309

  • Emory Midtown Infectious Disease Clinic /ID# 144015

    Atlanta, Georgia, 30322

  • Univ of Colorado Cancer Center /ID# 148194

    Aurora, Colorado, 80045

  • Austin Cancer Centers /ID# 151061

    Austin, Texas, 78758

  • St. Luke's Hospital /ID# 148191

    Bethlehem, Pennsylvania, 18017

  • Boca Raton Regional Hospital /ID# 163659

    Boca Raton, Florida, 33486

  • Tufts Medical Center /ID# 145897

    Boston, Massachusetts, 02111-1552

  • Massachusetts General Hospital /ID# 144145

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute /ID# 148475

    Boston, Massachusetts, 02215

  • MD Anderson Cancer Center at Cooper - Camden /ID# 145891

    Camden, New Jersey, 08103

  • Medical University of South Carolina /ID# 144141

    Charleston, South Carolina, 29425

  • Levine Cancer Ins, Carolina Me /ID# 144124

    Charlotte, North Carolina, 28204

  • Northwestern University Feinberg School of Medicine /ID# 147895

    Chicago, Illinois, 60611-2927

  • The University of Chicago Medical Center /ID# 144158

    Chicago, Illinois, 60637-1443

  • University of Cincinnati /ID# 144164

    Cincinnati, Ohio, 45267-0585

  • Duplicate_Univ Hosp Cleveland /ID# 144153

    Cleveland, Ohio, 44106

  • Cleveland Clinic Main Campus /ID# 144023

    Cleveland, Ohio, 44195

  • The Ohio State University /ID# 144016

    Columbus, Ohio, 43210

  • Baylor Sammons Cancer Center /ID# 155542

    Dallas, Texas, 75246

  • Wayne State University /ID# 145890

    Detroit, Michigan, 48201-2013

  • Henry Ford Health System /ID# 145896

    Detroit, Michigan, 48202

  • NorthShore University HealthSystem /ID# 144017

    Evanston, Illinois, 60201

  • Associated Neurologists of Sou /ID# 147701

    Fairfield, Connecticut, 06824

  • Inova Health System /ID# 152956

    Falls Church, Virginia, 22042

  • Holy Cross Hospital /ID# 156764

    Fort Lauderdale, Florida, 33308

  • Parkview Research Ctr, Hosp /ID# 144150

    Fort Wayne, Indiana, 46805

  • Penn State University and Milton S. Hershey Medical Center /ID# 147525

    Hershey, Pennsylvania, 17033

  • The University of Texas Health Science Center at Houston /ID# 144013

    Houston, Texas, 77030

  • University of Texas MD Anderson Cancer Center /ID# 144018

    Houston, Texas, 77030

  • University of Southern California /ID# 147543

    Los Angeles, California, 90033

  • University of California, Los Angeles /ID# 149239

    Los Angeles, California, 90095

  • Univ of Wisconsin Hosp/Clinics /ID# 144167

    Madison, Wisconsin, 53792-0001

  • Baptist Hospital Miami /ID# 152451

    Miami, Florida, 33176

  • Froedtert Memorial Lutheran Hospital /ID# 144139

    Milwaukee, Wisconsin, 53226-3522

  • Intermountain Medical Center /ID# 144142

    Murray, Utah, 84107-5701

  • Rutgers Cancer Institute of New Jersey /ID# 148190

    New Brunswick, New Jersey, 08901

  • Yale University /ID# 144170

    New Haven, Connecticut, 06510

  • Columbia University Medical Center /ID# 144020

    New York, New York, 10032-3729

  • Christiana Care Health Service /ID# 144127

    Newark, Delaware, 19713

  • Univ Oklahoma HSC /ID# 144161

    Oklahoma City, Oklahoma, 73104

  • Nebraska Methodist Hospital /ID# 144140

    Omaha, Nebraska, 68114

  • University of Nebraska Medical Center /ID# 145899

    Omaha, Nebraska, 68198

  • Advent Health /ID# 144128

    Orlando, Florida, 32803

  • University of Pennsylvania /ID# 157623

    Philadelphia, Pennsylvania, 19104-5502

  • Thomas Jefferson University /ID# 144191

    Philadelphia, Pennsylvania, 19107-4414

  • Fox Chase Cancer Center /ID# 145893

    Philadelphia, Pennsylvania, 19111

  • St. Josephs Hospital and Med Center /ID# 144149

    Phoenix, Arizona, 85013

  • Allegheny General Hospital /ID# 144126

    Pittsburgh, Pennsylvania, 15212

  • University of Pennsylvania Medical Center - Shadyside /ID# 144159

    Pittsburgh, Pennsylvania, 15232

  • Virginia Commonwealth University Medical Center Main Hospital /ID# 149014

    Richmond, Virginia, 23219

  • University of Rochester Medical Center /ID# 144166

    Rochester, New York, 14642

  • Mmcorc /Id# 144146

    Saint Louis Park, Minnesota, 55416

  • University of Utah /ID# 144160

    Salt Lake City, Utah, 84112-5500

  • Sharp Memorial Hospital /ID# 148193

    San Diego, California, 92123

  • Univ California, San Francisco /ID# 145889

    San Francisco, California, 94143-2204

  • Duplicate_St. John's Health Center /ID# 148192

    Santa Monica, California, 90404

  • Maine Medical Partners Neurolo /ID# 160864

    Scarborough, Maine, 04074

  • Virginia Mason Medical Center /ID# 144022

    Seattle, Washington, 98101

  • University of Washington /ID# 144162

    Seattle, Washington, 98109

  • Highlands Oncology Group, PA /ID# 142050

    Springdale, Arkansas, 72762

  • Washington University-School of Medicine /ID# 144174

    St Louis, Missouri, 63110

  • Moffitt Cancer Center /ID# 144130

    Tampa, Florida, 33612-9416

  • Duplicate_Scott and White Medical Center /ID# 160743

    Temple, Texas, 76508

  • University of Toledo /ID# 156763

    Toledo, Ohio, 43614

  • Northwestern Medicine Cancer Center - Warrenville /ID# 148476

    Warrenville, Illinois, 60555

  • Cedars-Sinai Medical Center-West Hollywood /ID# 148472

    West Hollywood, California, 90048

  • Univ Kansas Cancer Ctr - Overl /ID# 145895

    Westwood, Kansas, 66205-2003

  • Duplicate_St. Joseph Mercy Hospital /ID# 144143

    Ypsilanti, Michigan, 48197

Other trials in United States

China14 sites

  • SanboBrain Hospital Capital Medical University /ID# 166422

    Beijing, Beijing Municipality, 100042

  • Peking Union Medical College Hospital /ID# 157430

    Beijing, Beijing Municipality, 100730

  • Beijing Tian Tan Hospital, Capital Medical University /ID# 167160

    Beijing, 100070

  • Duplicate_Xiangya Hospital Central South University /ID# 166791

    Changsha, Hunan, 410008

  • The First Affiliated Hospital of Fujian Medical University /ID# 159166

    Fuzhou, 350005

  • Sun Yat-Sen University Cancer Center /ID# 143919

    Guangzhou, Guangdong, 510060

  • Duplicate_The Second Affiliated Hospital of ZUSM /ID# 165593

    Hangzhou, Zhejiang, 310009

  • Anhui Provincial Hospital /ID# 166320

    Hefei, Anhui, 230001

  • Duplicate_Huashan Hospital of Fudan University /ID# 159999

    Shanghai, Shanghai Municipality, 200040

  • Duplicate_Shengjing Hospital of China Medical University /ID# 167016

    Shenyang, 110004

  • The First Affiliated Hospital of Soochow University /ID# 165596

    Suzhou, Jiangsu, 215006

  • Duplicate_Tianjin Med Univ General Hosp /ID# 143923

    Tianjin, 300052

  • Tongji Hospital Tongji Medical College of HUST /ID# 163820

    Wuhan, Hubei, 430030

  • Duplicate_Tangdu Hospital /ID# 143920

    Xi'an, Shaanxi, 710038

Other trials in China

Canada12 sites

  • QE II Health Sciences Centre /ID# 151600

    Halifax, Nova Scotia, B3H 1V7

  • Juravinski Cancer Centre /ID# 152117

    Hamilton, Ontario, L8V 1C3

  • Victoria Hospital /ID# 144184

    London, Ontario, N6A 4L6

  • Duplicate_Hospital Maisonneuve-Rosemont /ID# 149315

    Montreal, Quebec, H1T 2M4

  • CHUM - Notre-Dame Hospital /ID# 144027

    Montreal, Quebec, H2X 0A9

  • Duplicate_Jewish General Hospital /ID# 144029

    Montreal, Quebec, H3T 1E2

  • Royal Victoria Hospital / McGill University Health Centre /ID# 144187

    Montreal, Quebec, H4A 3J1

  • Ottawa Hospital Research Institute /ID# 150120

    Ottawa, Ontario, K1H 8L6

  • CHU de Quebec-Universite Laval /ID# 144189

    Québec, Quebec, G1R 2J6

  • CHUS - Hopital Fleurimont /ID# 149771

    Sherbrooke, Quebec, J1H 5N4

  • Princess Margaret Cancer Centre /ID# 166277

    Toronto, Ontario, M5G 2M9

  • Duplicate_Cancer Care Manitoba /ID# 149253

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Australia11 sites

  • Royal Adelaide Hospital /ID# 143867

    Adelaide, South Australia, 5000

  • Calvary North Adelaide Hospita /ID# 143866

    Adelaide, South Australia, 5006

  • St Vincent's Hospital Melbourne /ID# 143858

    Fitzroy Melbourne, Victoria, 3065

  • Duplicate_Austin Hospital /ID# 143859

    Heidelberg, Victoria, 3084

  • Liverpool Hospital /ID# 144392

    Liverpool, New South Wales, 2170

  • Duplicate_The Prince of Wales Hospital /ID# 144882

    Randwick, New South Wales, 2031

  • Royal North Shore Hospital /ID# 143870

    St Leonards, New South Wales, 2065

  • St John Of God Subiaco Hospital /ID# 143869

    Subiaco, Western Australia, 6008

  • Calvary Mater Newcastle /ID# 143860

    Waratah, New South Wales, 2298

  • Southern Medical Day Care Centre /ID# 143868

    Wollongong, New South Wales, 2500

  • Princess Alexandra Hospital /ID# 143857

    Woolloongabba, Queensland, 4102

Other trials in Australia

United Kingdom9 sites

  • University Hospitals Birmingham NHS Foundation Trust /ID# 154592

    Birmingham, B15 2TH

  • Velindre University NHS Trust /ID# 141996

    Cardiff, CF15 7QZ

  • Duplicate_NHS Tayside /ID# 141651

    Dundee, DD2 1UB

  • NHS Lothian /ID# 141802

    Edinburgh, EH3 9HE

  • Leeds Teaching Hospitals NHS Trust /ID# 141653

    Leeds, LS9 7TF

  • Guys and St Thomas NHS Foundation Trust /ID# 142652

    London, London, City of, SE1 9RT

  • University College London Hospitals NHS Foundation Trust /ID# 142658

    London, NW1 2PG

  • Duplicate_The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 141999

    Newcastle upon Tyne, NE7 7DN

  • Royal Marsden Hospital /ID# 142827

    Sutton, SM2 5PT

Other trials in United Kingdom

France8 sites

  • Insititut de Cancerologie /ID# 143908

    Angers, 49933

  • Hopital Avicenne - APHP /ID# 143910

    Bobigny, Île-de-France Region, 93000

  • CHRU Lille - Hopital Claude Huriez /ID# 143915

    Lille, Hauts-de-France, 59037

  • AP-HM - Hopital de la Timone /ID# 143911

    Marseille, Bouches-du-Rhone, 13385

  • CHU Nice -Hopital Pasteur /ID# 143916

    Nice, Provence-Alpes-Côte d'Azur Region, 06002

  • Hopital Pitie Salpetriere /ID# 143917

    Paris, 75013

  • Institut de Cancérologie de l'Ouest René Gauducheau /ID# 143914

    Saint-Herblain, Loire-Atlantique, 44805

  • Duplicate_Gustave Roussy /ID# 143912

    Villejuif, Île-de-France Region, 94805

Other trials in France

Belgium7 sites

  • Grand Hopital de Charleroi /ID# 141645

    Charleroi, Hainaut, 6000

  • UZ Gent /ID# 141647

    Ghent, Oost-Vlaanderen, 9000

  • Duplicate_Centre Hospitalier Jolimont /ID# 143873

    La Louvière, 7100

  • Universitair Ziekenhuis Leuven /ID# 143872

    Leuven, Vlaams-Brabant, 3000

  • CHU de Liege /ID# 162860

    Liège, 4000

  • UCL Saint-Luc /ID# 141648

    Woluwe-Saint-Lambert, Brussels Capital, 1200

  • Duplicate_UCL Mont Godinne /ID# 141644

    Yvoir, 5530

Other trials in Belgium

Russia7 sites

  • Regional Clinical Hospital of Kaliningrad region /ID# 141702

    Kaliningrad, Kaliningrad Oblast, 236016

  • Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 141707

    Moscow, Moscow, 115478

  • National Medical Research Center for Neurosurgery n.a. N. N. Burdenko /ID# 141701

    Moscow, Moscow, 125047

  • Federal State Treatment and Rehabilitation center /ID# 141704

    Moscow, Moscow, 125367

  • GEMC - European Medical Center /ID# 141703

    Moscow, Moscow Oblast, 129090

  • State budgetary healthcare institution Republican Clinical Oncology Dispensary /ID# 141706

    Ufa, Kirov Oblast, 450054

  • Sverdlovsk Regional Oncology Dispensary /ID# 141700

    Yekaterinburg, Sverdlovsk Oblast, 620043

Other trials in Russia

Spain7 sites

  • Hospital Clinic de Barcelona /ID# 143906

    Barcelona, 08036

  • Hospital Santa Creu i Sant Pau /ID# 143900

    Barcelona, 08041

  • Hospital Clinico Universitario San Carlos /ID# 143901

    Madrid, 28040

  • Hospital Universitario 12 de Octubre /ID# 143930

    Madrid, 28041

  • Hospital Universitario HM Sanchinarro /ID# 143496

    Madrid, 28050

  • Hospital Regional de Malaga /ID# 143902

    Málaga, Malaga, 29010

  • Hospital General Universitario de Valencia /ID# 143903

    Valencia, 46014

Other trials in Spain

South Africa6 sites

  • University of Free State, Universitas Annex (National Hospital Grounds) /ID# 144064

    Bloemfontein, Free State, 9301

  • Netcare Oncology Intervent Ctr /ID# 143951

    Cape Town, Western Cape, 7460

  • Rondebosch Oncology Center /ID# 143949

    Cape Town, Western Cape, 7700

  • Netcare Unitas Hospital /ID# 152936

    Centurion, Gauteng, 0140

  • The Oncology Centre /ID# 143950

    Durban, KwaZulu-Natal, 4091

  • Cape Town Oncology Trials /ID# 143948

    Kraaifontein, Western Cape, 7570

Other trials in South Africa

Brazil5 sites

  • Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 143876

    Barretos, São Paulo, 14784-400

  • Liga Norte Riograndense Contra o Câncer /ID# 143878

    Natal, Rio Grande do Norte, 59075-740

  • Hospital Sao Lucas da PUCRS /ID# 143879

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 143877

    Rio de Janeiro, 20231-050

  • Instituto do Câncer do Estado de São Paulo - ICESP /ID# 144031

    São Paulo, São Paulo, 01246-000

Other trials in Brazil

Colombia5 sites

  • Administradora del Country_S.A-Clinica Del Country /ID# 143881

    Bogota, Cundinamarca, 110221

  • Centro Medico Imbanaco de Cali /ID# 143882

    Cali

  • Hospital Pablo Tobon Uribe /ID# 143780

    Medellín, Antioquia, 50034

  • Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 147223

    Montería, Departamento de Córdoba, 230002

  • Oncologos del Occidente S.A /ID# 147713

    Pereira, Risaralda Department, 66000

Other trials in Colombia

Czechia5 sites

  • Masarykuv onkologicky ustav /ID# 143884

    Brno, 656 53

  • Duplicate_FN Hradec Kralove /ID# 143885

    Hradec Králové, 500 05

  • Krajska nemocnice Liberec, a.s. /ID# 142024

    Liberec, 460 01

  • Duplicate_Univ Hosp Ostrava-Poruba /ID# 143883

    Ostrava, 708 52

  • Fakultni Nemocnice v Motole /ID# 142023

    Prague, 150 06

Other trials in Czechia

Israel5 sites

  • Rambam Health Care Campus /ID# 143959

    Haifa, 3109601

  • Gastroenterology Institute, Division of Medicine /ID# 143958

    Jerusalem, 91120

  • Rabin Medical Center /ID# 143957

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center /ID# 143960

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 143956

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Netherlands5 sites

  • Vrije Universiteit Medisch Centrum /ID# 143889

    Amsterdam, 1081 HV

  • Universitair Medisch Centrum Groningen /ID# 141408

    Groningen, 9713 GZ

  • Maastricht Universitair Medisch Centrum /ID# 143585

    Maastricht, 6229 HX

  • Haaglanden Medisch Centrum /ID# 141405

    The Hague, 2512 VA

  • Universitair Medisch Centrum Utrecht /ID# 141406

    Utrecht, 3584 CX

Other trials in Netherlands

Portugal5 sites

  • CCA Braga - Hospital de Braga /ID# 141940

    Braga, 4710-243

  • Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 141939

    Faro, 8000-386

  • IPO Lisboa FG, EPE /ID# 141938

    Lisbon, 1099-023

  • Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 141941

    Lisbon, 1649-035

  • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 142830

    Porto, 4200-319

Other trials in Portugal

South Korea5 sites

  • National Cancer Center /ID# 141845

    Goyang, Gyeonggido, 10408

  • Duplicate_Yonsei University Health System, Severance hospital. /ID# 141846

    Seoul, Seoul Teugbyeolsi, 03722

  • Seoul National University Hospital /ID# 143886

    Seoul, 03080

  • Samsung Medical Center /ID# 143887

    Seoul, 06351

  • The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 141844

    Seoul, 06591

Other trials in South Korea

Austria4 sites

  • Medizinische Universitaet Graz /ID# 141982

    Graz, Styria, 8036

  • Duplicate_Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Mediz /ID# 141984

    Innsbruck, 6020

  • Kepler Universitätsklinikum GmbH - Neuromed Campus /ID# 141983

    Linz, 4020

  • Medizinische Universitaet Wien /ID# 141981

    Vienna, State of Vienna, 1090

Other trials in Austria

Germany4 sites

  • Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH /ID# 143961

    Bochum, 44791

  • Universitaetsklinik Heidelberg /ID# 143927

    Heidelberg, Baden-Wurttemberg, 69120

  • Universitaetsklinikum Leipzig /ID# 143962

    Leipzig, Saxony, 04103

  • Universitaetsklinikum Tuebingen /ID# 143926

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Italy4 sites

  • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 141800

    Milan, 20133

  • Istituto Oncologico Veneto /ID# 143821

    Padova, 35128

  • Duplicate_Regina Elena National Cancer I /ID# 141795

    Rome, 00144

  • Duplicate_Duplicate_AOU Citta della Salute Scienza /ID# 141801

    Turin, Piedmont, 10126

Other trials in Italy

Switzerland4 sites

  • Kantonsspital Aarau AG /ID# 141885

    Aarau, Canton of Aargau, 5001

  • Duplicate_EOC Ospedale Regionale di Bellinzona e Valli /ID# 143936

    Bellinzona, 6500

  • Inselspital, Universitätsspital Bern /ID# 141886

    Bern, 3010

  • Universitatsspital Zurich /ID# 141887

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Taiwan3 sites

  • National Taiwan University Hospital /ID# 143940

    Taipei, 100

  • Taipei Veterans General Hosp /ID# 143955

    Taipei, 11217

  • Linkou Chang Gung Memorial Hospital /ID# 143941

    Taoyuan City, 333

Other trials in Taiwan

Argentina2 sites

  • Duplicate_Instituto Med Alex Flem /ID# 142884

    Buenos Aires, 1426

  • Sanatorio Parque /ID# 142825

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

New Zealand2 sites

  • Duplicate_Canterbury District Health Boa /ID# 143861

    Christchurch, 8011

  • Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 143890

    Wellington, 6021

Other trials in New Zealand

Singapore2 sites

  • National University Hospital /ID# 143933

    Singapore, 119074

  • National Cancer Ctr Singapore /ID# 143932

    Singapore, 169610

Other trials in Singapore

Hong Kong1 site

  • Prince of Wales Hospital /ID# 143952

    Hong Kong, 999077

Other trials in Hong Kong

Ireland1 site

  • Beaumont Hospital /ID# 142969

    Beaumont, Dublin, D09 XR63

Other trials in Ireland

Mexico1 site

  • Centro Medico Zambrano Hellion /ID# 143845

    San Pedro Garza García, Nuevo León, 66278

Other trials in Mexico

About this study

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)

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.

Being tested
Temozolomide, Depatuxizumab mafodotin, Radiation, Placebo for ABT-414
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
Medical subject headings
Glioblastoma, Gliosarcoma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TemozolomideDrug

    Oral Capsule

  • Depatuxizumab mafodotinDrug

    Also called ABT-414

    Intravenous (IV) Infusion

  • RadiationRadiation

  • Placebo for ABT-414Drug

    IV Infusion (IV)

Study groups in NCT02573324
Study groupRoleWhat they receive
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.
Receives: Drug: Temozolomide; Drug: Depatuxizumab mafodotin; Radiation: Radiation
Placebo, Radiation and TMZPlacebo 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.
Receives: Drug: Temozolomide; Radiation: Radiation; Drug: Placebo for ABT-414
Open-Label Sub-Study: Depatuxizumab Mafodotin, Radiation and TMZExperimentalDepatuxizumab 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.
Receives: Drug: Temozolomide; Drug: Depatuxizumab mafodotin; Radiation: Radiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).

Secondary outcomes (8)

  1. 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

    Measured: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).

  2. 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.

    Measured: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).

  3. 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.

    Measured: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).

  4. 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.

    Measured: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).

  5. 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.

    Measured: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).

  6. 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.

    Measured: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).

  7. 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.

    Measured: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).

  8. 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.

    Measured: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2015 (estimated)
  2. Study start4 Jan 2015
  3. Primary completion4 Apr 2022
  4. Study completion4 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
691 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02573324
Sponsor's protocol ID
M13-813
Other IDs
2015-001166-26, 2015
Acronym
Intellance1
Status last verified
May 2023
First submitted
28 Sep 2015
Last updated
11 May 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.
Expanded access
Available

Publications

  • 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.

    PubMed 29982805

  • 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.

    PubMed 29077941

  • 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.

    PubMed 28039367

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Temozolomide, Depatuxizumab mafodotin and Radiation in people with Glioblastoma and Gliosarcoma, run by AbbVie at 212 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 212 sites in United States, China, Canada, Australia, United Kingdom and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02573324, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in