A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02573324 |
Recruitment Status :
Active, not recruiting
First Posted : October 9, 2015
Last Update Posted : December 21, 2020
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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 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 |

Arm | Intervention/treatment |
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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.
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Drug: Temozolomide
Oral Capsule Drug: ABT-414 Intravenous Infusion (IV)
Other Names:
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.
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Drug: Temozolomide
Oral Capsule Radiation: Radiation Drug: Placebo for ABT-414 Intravenous Infusion (IV) |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573324

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 |
Study Director: | AbbVie Inc. | AbbVie |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AbbVie |
ClinicalTrials.gov Identifier: | NCT02573324 |
Other Study ID Numbers: |
M13-813 2015-001166-26 ( EudraCT Number ) |
First Posted: | October 9, 2015 Key Record Dates |
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 |
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 |
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 |