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

• ClinicalTrials.gov Identifier: NCT02573324
• Recruitment Status: Active, not recruiting
• First Posted: October 9, 2015
• Last Update Posted: December 21, 2020
• Sponsor: AbbVie
• Collaborator: Radiation Therapy Oncology Group
• Information provided by (Responsible Party): AbbVie

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.

Condition or disease	Intervention/treatment	Phase
Glioblastoma; Gliosarcoma	Drug: Temozolomide; Drug: ABT-414; Radiation: Radiation; Drug: Placebo for ABT-414	Phase 2; Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 691 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Placebo Controlled Phase 3 Study of ABT-414 With Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1)
• Actual Study Start Date: December 7, 2015
• Estimated Primary Completion Date: June 30, 2021
• Estimated Study Completion Date: June 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: ABT-414, Radiation and Radiation/Temozolomide (TMZ); ABT-414 is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. ABT-414 is given on Day 1 & 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.	Drug: Temozolomide; Oral Capsule; Drug: ABT-414; Intravenous Infusion (IV); Other Names: Depatuxizumab; Mafodotin; Radiation: Radiation
Placebo Comparator: Placebo, Radiation and TMZ; Placebo is given on Day 1 of Week 1, 3 and 5 along with the standard therapy of TMZ and radiation during the chemoradiation phase. Placebo is given on Day 1 & 15 of each cycle along with TMZ (Days 1-5 of each cycle) per standard of care during the adjuvant phase.	Drug: Temozolomide; Oral Capsule; Radiation: Radiation; Drug: Placebo for ABT-414; Intravenous Infusion (IV)

Outcome Measures

Primary Outcome Measures :

1. Overall Survival (OS) [ Time Frame: Quarterly After Treatment Discontinuation for Approximately 4 Years ]
   Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.

Secondary Outcome Measures :

1. Progression-Free Survival (PFS) [ Time Frame: Baseline Day 0 Through Approximately 4 years ]
   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.
2. OS for the O6-methylguaninemethlytransferese (MGMT) Unmethylated Group [ Time Frame: Baseline Day 0 Through Approximately 4 years ]
   Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.
3. OS for the MGMT Methylated Group [ Time Frame: Baseline Day 0 Through Approximately 4 years ]
   Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.
4. Time to Deterioration in Symptom Severity Score M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) [ Time Frame: Baseline Day 0 Through Approximately 4 years ]
   The MDASI-BT is a participant self-report or interviewer-administered measure used to assess the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours.
5. Time to Deterioration in Symptom Interference Score MDASI-BT [ Time Frame: Baseline Day 0 Through Approximately 4 years ]
   The MDASI-BT is a participant self-report or interviewer-administered measure used to assess the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours.
6. Time to Deterioration in Neurocognitive Functioning on the Hopkins Verbal Learning Test Revised (HVLT-R) [ Time Frame: Baseline Day 0 Through Approximately 4 years ]
   The HVLT-R will assess neurocognitive changes across time.
7. OS for the Epidermal Growth Factor Receptor (EGFR)vIII-Mutated Tumor Subgroup [ Time Frame: Baseline Day 0 Through Approximately 4 years ]
   Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.
8. PFS for EGFRvIII-Mutated Tumor Subgroup [ Time Frame: Baseline Day 0 Through Approximately 4 years ]
   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.
9. Number of Adverse Events (AE) [ Time Frame: Baseline Day 0 Through Approximately 4 years ]
   An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 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.

Contacts and Locations

Locations

United States, Arizona

St. Josephs Hosp and Med Ctr /ID# 144149

Phoenix, Arizona, United States, 85013

United States, Arkansas

Highlands Oncology Group /ID# 142050

Springdale, Arkansas, United States, 72762

United States, California

Usc /Id# 147543

Los Angeles, California, United States, 90033

University of California, Los Angeles /ID# 149239

Los Angeles, California, United States, 90095

Sharp Memorial Hospital /ID# 148193

San Diego, California, United States, 92123

Univ California, San Francisco /ID# 145889

San Francisco, California, United States, 94143-2204

St. John's Health Center /ID# 148192

Santa Monica, California, United States, 90404

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

West Hollywood, California, United States, 90048

United States, Colorado

Univ of Colorado Cancer Center /ID# 148194

Aurora, Colorado, United States, 80045

United States, Connecticut

Associated Neurologists of Sou /ID# 147701

Fairfield, Connecticut, United States, 06824

Yale University /ID# 144170

New Haven, Connecticut, United States, 06510

United States, Delaware

Christiana Care Health Service /ID# 144127

Newark, Delaware, United States, 19713

United States, Florida

Boca Raton Regional Hospital /ID# 163659

Boca Raton, Florida, United States, 33486

Holy Cross Hospital /ID# 156764

Fort Lauderdale, Florida, United States, 33308

Baptist Hospital Miami /ID# 152451

Miami, Florida, United States, 33176

Florida Hospital /ID# 144128

Orlando, Florida, United States, 32803

Moffitt Cancer Center /ID# 144130

Tampa, Florida, United States, 33612-9416

United States, Georgia

Piedmont Hospital /ID# 145892

Atlanta, Georgia, United States, 30309

Winship Cancer Institute of Emory University /ID# 144015

Atlanta, Georgia, United States, 30322

United States, Illinois

Northwestern University Feinberg School of Medicine /ID# 147895

Chicago, Illinois, United States, 60611-2927

University of Chicago DCAM /ID# 144158

Chicago, Illinois, United States, 60637-1443

NorthShore University HealthSystem - Evanston Hospital /ID# 144017

Evanston, Illinois, United States, 60201

Northwestern Medicine Cancer Center - Warrenville /ID# 148476

Warrenville, Illinois, United States, 60555

United States, Indiana

Parkview Research Ctr, Hosp /ID# 144150

Fort Wayne, Indiana, United States, 46805

United States, Kansas

Univ Kansas Cancer Ctr - Overl /ID# 145895

Westwood, Kansas, United States, 66205-2003

United States, Maine

Maine Medical Partners Neurolo /ID# 160864

Scarborough, Maine, United States, 04074

United States, Massachusetts

Tufts Medical Center /ID# 145897

Boston, Massachusetts, United States, 02111

Massachusetts General Hospital /ID# 144145

Boston, Massachusetts, United States, 02114

Dana-Farber Cancer Institute /ID# 148475

Boston, Massachusetts, United States, 02215

United States, Michigan

Wayne State University /ID# 145890

Detroit, Michigan, United States, 48201-2013

Henry Ford Health System /ID# 145896

Detroit, Michigan, United States, 48202

St. Joseph Mercy Hospital /ID# 144143

Ypsilanti, Michigan, United States, 48106

United States, Minnesota

Mmcorc /Id# 144146

Saint Louis Park, Minnesota, United States, 55416

United States, Missouri

Washington University-School of Medicine /ID# 144174

Saint Louis, Missouri, United States, 63110

United States, Nebraska

Nebraska Methodist Hospital /ID# 144140

Omaha, Nebraska, United States, 68114

Univ Nebraska Med Ctr /ID# 145899

Omaha, Nebraska, United States, 68198

United States, New Jersey

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

Camden, New Jersey, United States, 08103

Rutgers Cancer Institute of NJ /ID# 148190

New Brunswick, New Jersey, United States, 08903

United States, New York

Columbia University Medical Center /ID# 144020

New York, New York, United States, 10032-3729

Univ Rochester Med Ctr /ID# 144166

Rochester, New York, United States, 14642

United States, North Carolina

Levine Cancer Ins, Carolina Me /ID# 144124

Charlotte, North Carolina, United States, 28204

United States, Ohio

University of Cincinnati /ID# 144164

Cincinnati, Ohio, United States, 45267-0585

Univ Hosp Cleveland /ID# 144153

Cleveland, Ohio, United States, 44106

Cleveland Clinic Main Campus /ID# 144023

Cleveland, Ohio, United States, 44195

The Ohio State University /ID# 144016

Columbus, Ohio, United States, 43210

University of Toledo /ID# 156763

Toledo, Ohio, United States, 43614

United States, Oklahoma

Univ Oklahoma HSC /ID# 144161

Oklahoma City, Oklahoma, United States, 73104

United States, Pennsylvania

St. Luke's Hospital /ID# 148191

Bethlehem, Pennsylvania, United States, 18017

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

Hershey, Pennsylvania, United States, 17033

University of Pennsylvania /ID# 157623

Philadelphia, Pennsylvania, United States, 19104-5502

Thomas Jefferson University /ID# 144191

Philadelphia, Pennsylvania, United States, 19107-4414

Fox Chase Cancer Center /ID# 145893

Philadelphia, Pennsylvania, United States, 19111

Allegheny General Hospital /ID# 144126

Pittsburgh, Pennsylvania, United States, 15212

UPMC - Shadyside /ID# 144159

Pittsburgh, Pennsylvania, United States, 15232

United States, South Carolina

Medical University of South Carolina /ID# 144141

Charleston, South Carolina, United States, 29425

United States, Texas

Austin Cancer Centers /ID# 151061

Austin, Texas, United States, 78758

Baylor Sammons Cancer Center /ID# 155542

Dallas, Texas, United States, 75246

University of Texas MD Anderson Cancer Center /ID# 144018

Houston, Texas, United States, 77030

UT Health Science Ctr-Houston /ID# 144013

Houston, Texas, United States, 77030

Scott and White Medical Center /ID# 160743

Temple, Texas, United States, 76508

United States, Utah

Intermountain Medical Center /ID# 144142

Murray, Utah, United States, 84107-5701

University of Utah /ID# 144160

Salt Lake City, Utah, United States, 84112-5500

United States, Virginia

Inova Health System /ID# 152956

Falls Church, Virginia, United States, 22042

Virginia Commonwealth Univ /ID# 149014

Richmond, Virginia, United States, 23219

United States, Washington

Virginia Mason Medical Center /ID# 144022

Seattle, Washington, United States, 98101

University of Washington /ID# 144162

Seattle, Washington, United States, 98109

United States, Wisconsin

Univ of Wisconsin Hosp/Clinics /ID# 144167

Madison, Wisconsin, United States, 53792-0001

Froedtert Memorial Lutheran Hospital /ID# 144139

Milwaukee, Wisconsin, United States, 53226-3522

Argentina

Instituto Med Alex Flem /ID# 142884

Buenos Aires, Argentina, 1426

Sanatorio Parque S.A. - Grupo /ID# 142825

Rosario, Santa FE, Argentina, 2000

Australia, New South Wales

Liverpool Hospital /ID# 144392

Liverpool, New South Wales, Australia, 2170

The Prince of Wales Hospital /ID# 144882

Randwick, New South Wales, Australia, 2031

Royal North Shore Hospital /ID# 143870

Saint Leonards, New South Wales, Australia, 2065

Calvary Mater Newcastle /ID# 143860

Waratah, New South Wales, Australia, 2298

Southern Medical Day Care Ctr /ID# 143868

Wollongong, New South Wales, Australia, 2500

Australia, Queensland

Princess Alexandra Hospital /ID# 143857

Woolloongabba, Queensland, Australia, 4102

Australia, South Australia

Royal Adelaide Hospital /ID# 143867

Adelaide, South Australia, Australia, 5000

Calvary North Adelaide Hospita /ID# 143866

Adelaide, South Australia, Australia, 5006

Australia, Victoria

St. Vincents Hosp Melbourne /ID# 143858

Fitzroy, Victoria, Australia, 3065

Austin Hospital /ID# 143859

Heidelberg, Victoria, Australia, 3084

Australia, Western Australia

St. John of God Subiaco Hosp /ID# 143869

Subiaco, Western Australia, Australia, 6008

Austria

Medizinische Universitat Wien /ID# 141981

Vienna, Wien, Austria, 1090

LKH-Univ. Klinikum Graz /ID# 141982

Graz, Austria, 8036

Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Medizin 1 /ID# 141984

Innsbruck, Austria, 6020

Kepler Universitätsklinikum GmbH - Neuromed Campus /ID# 141983

Linz, Austria, 4020

Belgium

Cliniques Universitaires Saint Luc /ID# 141648

Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200

Grand Hôpital de Charleroi /ID# 141645

Charleroi, Hainaut, Belgium, 6000

UZ Gent /ID# 141647

Gent, Oost-Vlaanderen, Belgium, 9000

Centre Hospitalier Jolimont /ID# 143873

La Louvière, Belgium, 7100

UZ Leuven /ID# 143872

Leuven, Belgium, 3000

CHU de Liege /ID# 162860

Liege, Belgium, 4000

UCL Mont Godinne /ID# 141644

Yvoir, Belgium, 5530

Brazil

Liga Norte Rigrandese Contra o /ID# 143878

Natal, Rio Grande Do Norte, Brazil, 59062-000

Hospital Sao Lucas da PUCRS /ID# 143879

Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000

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

Barretos, Sao Paulo, Brazil, 14784-400

Icesp /Id# 144031

São Paulo, Sao Paulo, Brazil, 01246-000

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

Rio de Janeiro, Brazil, 20231-050

Canada, Manitoba

Cancer Care Manitoba /ID# 149253

Winnipeg, Manitoba, Canada, R3E 0V9

Canada, Nova Scotia

Qe Ii Hsc /Id# 151600

Halifax, Nova Scotia, Canada, B3H 1V7

Canada, Ontario

Juravinski Cancer Clinic /ID# 152117

Hamilton, Ontario, Canada, L8V 1C3

Victoria Hospital /ID# 144184

London, Ontario, Canada, N6A 4L6

The Ottawa Hospital /ID# 150120

Ottawa, Ontario, Canada, K1H 8L6

Princess Margaret Cancer Centre /ID# 166277

Toronto, Ontario, Canada, M5G 2M9

Canada, Quebec

Hospital Maisonneuve-Rosemont /ID# 149315

Montreal, Quebec, Canada, H1T 2M4

Montreal General Hospital - McGill University Health Center /ID# 144187

Montreal, Quebec, Canada, H3G 1A4

Jewish General Hospital /ID# 144029

Montreal, Quebec, Canada, H3T 1E2

CHUM - Notre-Dame Hospital /ID# 144027

Montréal, Quebec, Canada, H2X 0A9

CHU de Quebec-Universite Laval /ID# 144189

Quebec City, Quebec, Canada, G1R 2J6

CHUS - Hopital Fleurimont /ID# 149771

Sherbrooke, Quebec, Canada, J1H 5N4

China, Anhui

Anhui Provincial Hospital /ID# 166320

Hefei, Anhui, China, 230001

China, Hunan

Xiangya Hospital Central South University /ID# 166791

Changsha, Hunan, China, 410008

China, Jiangsu

The First Affiliated Hospital of Soochow University /ID# 165596

Suzhou, Jiangsu, China, 215006

China, Shanghai

Huashan Hospital of Fudan University /ID# 159999

Shanghai, Shanghai, China, 200040

China, Zhejiang

The Second Affiliated Hospital /ID# 165593

Hangzhou, Zhejiang, China, 310009

China

Sanbo Brain Hospital Capital M /ID# 166422

Beijing, China, 100042

Beijing Tian Tan Hospital /ID# 167160

Beijing, China, 100070

Peking Union Medical College H /ID# 157430

Beijing, China, 100730

1st Affiliated Hosp Fujian Med /ID# 159166

Fuzhou, China, 350005

Sun Yat-Sen Uni Cancer Center /ID# 143919

Guangzhou, Guangdong, China, 510060

Shengjing Hospital of China Medical University /ID# 167016

Shenyang, China, 110004

Tianjin Med Univ General Hosp /ID# 143923

Tianjin, China, 300052

Tongji Hosp Tongji Med College /ID# 163820

Wuhan, China, 430030

Fourth Military Medical University Tangdu Hospital, PLA /ID# 143920

Xi'an, China, 710038

Colombia

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

Bogota, Cundinamarca, Colombia, 110221

Centro Medico Imbanaco de Cali /ID# 143882

Cali, Colombia

Hospital Pablo Tobon Uribe /ID# 143780

Medellín, Colombia

Inst Med Alta Tec Onc (IMAT) /ID# 147223

Montería, Colombia, 230002

Oncologos de Occidente SA /ID# 147713

Pereira, Colombia

Czechia

Fakultni Nemocnice v Motole /ID# 142023

Prague 5, Praha 5, Czechia, 150 06

Masarykuv onkologikcy ustav /ID# 143884

Brno, Czechia, 656 53

FN Hradec Kralove /ID# 143885

Hradec Kralove, Czechia, 500 05

Krajska nemocnice Liberec a.s. /ID# 142024

Liberec, Czechia, 602 00

Univ Hosp Ostrava-Poruba /ID# 143883

Ostrava, Czechia, 708 52

France

CHRU Lille - Hopital Claude Huriez /ID# 143915

Lille CEDEX, Hauts-de-France, France, 59045

CHU-Hopital Avicenne /ID# 143910

Bobigny, Ile-de-France, France, 93000

Gustave Roussy /ID# 143912

Villejuif, Ile-de-France, France, 94805

Institut de Cancer de l'Ouest /ID# 143914

St Herblain CEDEX, Loire-Atlantique, France, 44805

Hopital de la Timone /ID# 143911

Marseille CEDEX 05, Provence-Alpes-Cote-d Azur, France, 13385

CHU de Nice /ID# 143916

Nice CEDEX 1, Provence-Alpes-Cote-d Azur, France, 06002

Insititut de Cancerologie /ID# 143908

Angers, France, 49933

Hopital Pitie Salpetriere /ID# 143917

Paris, France, 75651

Germany

Universitaetsklinik Heidelberg /ID# 143927

Heidelberg, Baden-Wuerttemberg, Germany, 69120

Universitaetsklinikum Leipzig /ID# 143962

Leipzig, Sachsen, Germany, 04103

Knappschaftskrankenhaus /ID# 143961

Bochum, Germany, 44791

Universitatsklinikum Tubingen /ID# 143926

Tuebingen, Germany, 72076

Hong Kong

Prince of Wales Hospital /ID# 143952

Hong Kong, Hong Kong, 999077

Ireland

Beaumont Hospital /ID# 142969

Dublin, Ireland, D09 XR63

Israel

Rabin Medical Center /ID# 143957

Petakh Tikva, Tel-Aviv, Israel, 4941492

Tel Aviv Sourasky Medical Center /ID# 143956

Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906

Rambam Health Care Campus /ID# 143959

Haifa, Israel, 3109601

Gastroenterology Institute, Division of Medicine /ID# 143958

Jerusalem, Israel, 91120

Sheba Medical Center /ID# 143960

Ramat Gan, Israel, 5239424

Italy

AOU Citta della Salute Scienza /ID# 141801

Turin, Piemonte, Italy, 10126

Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 141800

Milan, Italy, 20133

Istituto Oncologico Veneto /ID# 143821

Padova, Italy, 35128

Regina Elena National Cancer I /ID# 141795

Rome, Italy, 00144

Korea, Republic of

National Cancer Center /ID# 141845

Goyang, Gyeonggido, Korea, Republic of, 10408

Severance Hospital /ID# 141846

Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722

Samsung Medical Center /ID# 143887

Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351

Cath Univ Seoul St Mary's Hosp /ID# 141844

Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06591

Seoul National University Hospital /ID# 143886

Seoul, Korea, Republic of, 03080

Mexico

Hospital Zambrano Hellion /ID# 143845

San Pedro Garza Garcia, Nuevo Leon, Mexico, 66278

Netherlands

Vrije Universiteit Medisch Centrum /ID# 143889

Amsterdam, Netherlands, 1081 HV

Universitair Medisch Centrum Groningen /ID# 141408

Groningen, Netherlands, 9713 GZ

Maastricht Universitair Medisch Centrum /ID# 143585

Maastricht, Netherlands, 6229 HX

Haaglanden Medisch Centrum /ID# 141405

The Hague, Netherlands, 2512 VA

Universitair Medisch Centrum Utrecht /ID# 141406

Utrecht, Netherlands, 3584 CX

New Zealand

Canterbury District Health Boa /ID# 143861

Christchurch, New Zealand, 8011

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

Wellington, New Zealand, 6021

Portugal

CCA Braga - Hospital de Braga /ID# 141940

Braga, Portugal, 4710-243

Centro Hospitalar do Algarve /ID# 141939

Faro, Portugal, 8000-386

IPO Lisboa FG, EPE /ID# 141938

Lisboa, Portugal, 1099-023

Centro Hospitalar Lisboa Norte, EPE /ID# 141941

Lisboa, Portugal, 1649-035

Centro Hospitalar de Sao Joao, EPE /ID# 142830

Porto, Portugal, 4200-319

Russian Federation

Interregional clin.diagnostic cntr /ID# 141702

Kaliningrad, Kaliningradskaya Oblast, Russian Federation, 236016

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

UFA, Republic Of Bashkortosta, Kirovskaya Oblast, Russian Federation, 450054

GEMC - European Medical Center /ID# 141703

Moscow, Moskovskaya Oblast, Russian Federation, 129090

Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 141707

Moscow, Moskva, Russian Federation, 115478

Scientific and Research Inst. /ID# 141701

Moscow, Moskva, Russian Federation, 125047

Federal State Treatment and rehabilitation center /ID# 141704

Moscow, Moskva, Russian Federation, 125367

Sverdlovsk Regional Oncology Center Dispensary /ID# 141700

Ekaterinburg, Sverdlovskaya Oblast, Russian Federation, 620043

Singapore

National University Hospital /ID# 143933

Singapore, Singapore, 119074

National Cancer Ctr Singapore /ID# 143932

Singapore, Singapore, 169610

South Africa

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

Bloemfontein, Free State, South Africa, 9301

Unitas Hospital /ID# 152936

Centurion, Gauteng, South Africa, 0140

The Oncology Centre /ID# 143950

Durban, Kwazulu-Natal, South Africa, 4091

Netcare Oncology Intervent Ctr /ID# 143951

Cape Town, Western Cape, South Africa, 7460

Cape Town Oncology Trials /ID# 143948

Cape Town, Western Cape, South Africa, 7570

GVI Rondebosch Oncology Centre /ID# 143949

Cape Town, Western Cape, South Africa, 7700

Spain

Hospital Regional de Malaga /ID# 143902

Málaga, Malaga, Spain, 29010

Hospital Clinic /ID# 143906

Barcelona, Spain, 08036

Hospital Santa Creu i Sant Pau /ID# 143900

Barcelona, Spain, 08041

Hospital Clinico Universitario San Carlos /ID# 143901

Madrid, Spain, 28040

Hospital Universitario 12 de Octubre /ID# 143930

Madrid, Spain, 28041

Hospital Universitario HM Sanchinarro /ID# 143496

Madrid, Spain, 28050

Hospital General Universitario de Valencia /ID# 143903

Valencia, Spain, 46014

Switzerland

Universitaetsspital Zuerich /ID# 141887

Zurich, Zuerich, Switzerland, 8006

Kantonsspital Aarau /ID# 141885

Aarau, Switzerland, 5001

Ente Ospedaliero Cantonale /ID# 143936

Bellinzona, Switzerland, 6500

Inselspital, Universitaetsklinik /ID# 141886

Bern, Switzerland, 3010

Taiwan

National Taiwan Univ Hosp /ID# 143940

Taipei City, Taipei, Taiwan, 10002

Taipei Veterans General Hosp /ID# 143955

Taipei City, Taiwan, 11217

Linkou Chang Gung Memorial Ho /ID# 143941

Taoyuan City, Taiwan, 33305

United Kingdom

Guy's and St Thomas' NHS Found /ID# 142652

London, London, City Of, United Kingdom, SE1 9RT

Univ Hospitals Birmingham NHS Foundation trust /ID# 154592

Birmingham, United Kingdom, B15 2TG

Velindre Cancer Centre /ID# 141996

Cardiff, United Kingdom, CF14 2TL

Ninewells Hospital /ID# 141651

Dundee, United Kingdom, DD1 9SY

Western General Hospital /ID# 141802

Edinburgh, United Kingdom, EH4 2XU

St. James University Hospital /ID# 141653

Leeds, United Kingdom, LS9 7TF

University College Hospitals /ID# 142658

London, United Kingdom, NW1 2BU

The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 141999

Newcastle Upon Tyne, United Kingdom, NE7 7DN

Royal Marsden Hospital /ID# 142827

Sutton, United Kingdom, SM2 5PT

Sponsors and Collaborators

AbbVie

Radiation Therapy Oncology Group

Investigators

• Study Director: AbbVie Inc.; AbbVie

More Information

Additional Information:

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT02573324
• Other Study ID Numbers: M13-813; 2015-001166-26 ( EudraCT Number )
• First Posted: October 9, 2015
• Last Update Posted: December 21, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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 and 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• 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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
• URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:

Newly Diagnosed Glioblastoma; Epithelial Growth Factor Receptor (EGFR); Temozolomide; ABT-414; Radiology Therapy Oncology Group; Antibody Drug Conjugate; Brain Tumor; Brain Tumor Group; EGFRvIII; EGFR Amplified; First Line Therapy; Brain Cancer

Additional relevant MeSH terms:

Glioblastoma; Gliosarcoma; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Temozolomide; Immunoconjugates; Antineoplastic Agents, Alkylating; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs