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Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas (INTELLANCE 2) (INTELLANCE 2)

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: NCT02343406
Recruitment Status : Active, not recruiting
First Posted : January 22, 2015
Last Update Posted : May 27, 2019
Sponsor:
Collaborator:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by (Responsible Party):
AbbVie

Brief Summary:

This study is to evaluate the efficacy and safety of ABT-414 alone or with temozolomide versus temozolomide or lomustine alone in participants with recurrent glioblastoma multiforme.

The study includes a Pediatric sub-study to evaluate safety, tolerability and pharmacokinetics of ABT-414 in a pediatric population.

Adult enrollment has been completed and the study is now only recruiting for pediatric participants.


Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Drug: Lomustine Drug: ABT-414 Drug: Temozolomide Phase 2

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Detailed Description:
The pediatric sub-study is an uncontrolled, open-label, single-arm global study. This sub-study is to evaluate the safety, tolerability, and pharmacokinetics of ABT-414 in a pediatric population less than 18 years of age as well as to assess the effect of ABT-414 on tumor response per Response Assessment in Neuro-Oncology (RANO) criteria.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma: A Randomized Phase II Study of the EORTC Brain Tumor Group (EORTC Protocol 1410-BTG) Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas
Actual Study Start Date : February 11, 2015
Estimated Primary Completion Date : December 27, 2019
Estimated Study Completion Date : December 15, 2020


Arm Intervention/treatment
Experimental: Arm 4 Pediatric sub-study
ABT-414 at a dose of 1.0 mg/kg for participants who are 6 to 17 years old (at the date of first ABT-414 dose), or 1.3 mg/kg for participants who are 0 to 5 years old administered via intravenous infusion every other week. Prophylactic steroid eye drops (temozolomide) will be administered as described for the adult participants. Investigator discretion to use ABT-414 as monotherapy or in combination with temozolomide. The use of TMZ in combination with ABT-414 for a pediatric patient must be reviewed by the EORTC/AbbVie medical monitor prior to the initiation of therapy.
Drug: ABT-414
ABT-414 will be administered by intravenous infusion over approximately 30-40 minutes.
Other Names:
  • Depatuxizumab Mafodotin
  • Depatux-m

Experimental: Arm 2
ABT-414 administered every two weeks as monotherapy
Drug: ABT-414
ABT-414 will be administered by intravenous infusion over approximately 30-40 minutes.
Other Names:
  • Depatuxizumab Mafodotin
  • Depatux-m

Active Comparator: Arm 3A
Lomustine: For patients relapsing during TMZ treatment, or within 16 weeks after first day of last TMZ cycle: Lomustine will be administered on day 1 of every 42 day cycle.
Drug: Lomustine
Lomustine will be administered orally.

Drug: ABT-414
ABT-414 will be administered by intravenous infusion over approximately 30-40 minutes.
Other Names:
  • Depatuxizumab Mafodotin
  • Depatux-m

Experimental: Arm 1
ABT-414 administered via intravenous infusion every two weeks in combination with Temozolomide
Drug: ABT-414
ABT-414 will be administered by intravenous infusion over approximately 30-40 minutes.
Other Names:
  • Depatuxizumab Mafodotin
  • Depatux-m

Drug: Temozolomide
Temozolomide (TMZ) will be administered orally.

Active Comparator: Arm 3B
Temozolomide re-challenge: For patients that relapse 16 weeks or more after the first day of last dose of TMZ cycle: TMZ will be administered on day 1-5 of every 28 day cycle
Drug: ABT-414
ABT-414 will be administered by intravenous infusion over approximately 30-40 minutes.
Other Names:
  • Depatuxizumab Mafodotin
  • Depatux-m

Drug: Temozolomide
Temozolomide (TMZ) will be administered orally.




Primary Outcome Measures :
  1. Pediatric study: Maximum observed serum concentration (Cmax) for ABT-414 [ Time Frame: Samples collected at various time points from Cycle 1 Day 1 up to 49 days after the participant's last dose of study drug ]
    Cmax is the peak concentration that a drug achieves in a specified compartment after the drug has been administrated and before administration of a second dose.

  2. Adult study: Progression Free Survival (PFS) [ Time Frame: PFS will be measured every 8 weeks from date of randomization until the date of first objective progression or participant's death, whichever occurs first, up to 2 years. This will be assessed at interim analysis, when 45 PFS events are observed. ]
    Progression Free Survival per RANO criteria is the length of time during and after the treatment of a disease, that the participant lives with the disease but does not get worse.

  3. Pediatric study: AUC for Cys-mcMMAF (toxin, identified as a metabolite of ABT-414) [ Time Frame: Samples collected Cycle 1 Days 1, 2, 3, 5, 8 ]
    AUC is a measure of how long and how much drug or drug metabolite is present in the body after dosing. AUC in pediatric population will be compared following treatment, to check that this is comparable to adults, and the dosing levels are appropriate for a pediatric population.

  4. Pediatric study: Half-life (t1/2) observed for ABT-414 [ Time Frame: Samples collected at various time points from Cycle 1 Day 1 up to 35 days after the participant's last dose of study drug. ]
    Half-life is the calculated time it takes for half of the drug to leave the body.

  5. Pediatric study: Area Under the Concentration-time Curve (AUC) observed for ABT-414 [ Time Frame: Samples collected at various time points from Cycle 1 Day 1 up to 35 days after the participant's last dose of study drug. ]
    AUC is a measure of how long and how much drug is present in the body after dosing. AUC in pediatric population will be compared following treatment, to check that this is comparable to adults, and the dosing levels are appropriate for a pediatric population.

  6. Pediatric study: Maximum observed plasma concentration (Cmax) for Cys-mcMMAF (toxin, identified as a metabolite of ABT-414) [ Time Frame: Samples collected Cycle 1 Days 1, 2, 3, 5, 8 ]
    Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administrated and before administration of a second dose.

  7. Pediatric study: t1/2 for Cys-mcMMAF (toxin, identified as a metabolite of ABT-414) [ Time Frame: Samples collected Cycle 1 Days 1, 2, 3, 5, 8 ]
    Half-life is the calculated time it takes for half of the drug or drug metabolite to leave the body.

  8. Adult study: Overall Survival (OS) [ Time Frame: Measured from the date of randomization up to the date of participant's death. Participants who complete treatment will be assessed every 12 weeks, up to 28 months. ]
    Overall Survival (OS) is defined as number of days from the date of randomization to the date of death for all dosed participants.

  9. Pediatric study: Safety including toxicities according to CTCAE criteria [ Time Frame: From participants first visit until 49 days after the participant's last dose of study drug ]
    The severity of each adverse event is rated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 4.0)


Secondary Outcome Measures :
  1. Pediatric study: Objective response rate, best response rate and duration of response based on RANO criteria [ Time Frame: Evaluated every 8 weeks (+/- 7 days) at each assessment of disease according to RANO criteria, until progression or withdrawal up to approximately 52 weeks. ]
    Objective response includes best overall responses (complete response and partial response)

  2. Pediatric study: Overall survival, Time to progression and Time to progression-free survival [ Time Frame: Time to progression and time to progression-free survival will be measured every 8 weeks (+/- 7 days) from date of enrollment until the date of first objective progression or participant's death, whichever occurs first, upto approximately 52 weeks ]
    Overall survival is defined as number of days from the date of enrollment to the date of death for all dosed participation. Progression Free Survival per RANO criteria is the length of time during and after the treatment of a disease, that the participant lives with the disease but does not progress.

  3. Adult study: Overall Response Rate (ORR) [ Time Frame: The overall response rate will be evaluated every 8 weeks at each assessment of disease according to RANO criteria, up to 28 months. ]
    Overall Response Rate will look at those complete responders and partial responders

  4. Pediatric study: Changes in neurological status and function (including PedsQL cancer module) [ Time Frame: Neurological status and functioning is assessed at baseline, day 1 and 15 of each cycle, every 6 months for 5 years thereafter and then annually PedsQL evaluated at baseline, week 16 on treatment and at 6 months. ]
    The Pediatric Quality of Life Inventory (PedsQL) is a modular instrument designed to measure health-related quality of life (HRQOL) in children and adolescents ages 2-18 years. Neurological status and functioning will be assessed also at physical examination during the study

  5. Adult study: Progression Free Survival (PFS) [ Time Frame: Progression Free Survival will be measured every 8 weeks from date of randomization until the date of first objective progression or date of participant's death, whichever occurs first, assessed up to 28 months. ]
    Progression Free Survival per RANO criteria is the length of time during and after the treatment of a disease, that the participant lives with the disease but does not get worse.

  6. Adult study: Overall Survival in the subgroup with Epithelial Growth Factor Receptor (EGFRvIII) mutation [ Time Frame: Measured from date of randomization until death, or lost to follow up, assessed up to 28 months. ]
    Overall Survival (OS) is defined as number of days from the date of randomization to the date of death for all randomized participants that have EGFR vIII mutation.



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   up to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Adult participants (greater than or equal to 18 years old):

  • Histologically confirmed de novo (primary) Glioblastoma Multiforme with unequivocal tumor progression or recurrence.
  • In case of testing at the time of first progression: either at least 3 months after the end of radiotherapy or have tumor progression that is clearly outside the radiation field or have tumor progression unequivocally proven by surgery/biopsy
  • Absence of any psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule; such conditions should be assessed with the patient before registration in the trial.
  • Availability of adequate biological material (formalin-fixed paraffin embedded [FFPE] tumor) for central testing of Epithelial Growth Factor Receptor (EGFR) amplification
  • Presence of EGFR amplification confirmed by central assessment; participants with undetermined EGFR status are excluded
  • World Health Organization (WHO) Performance status 0 - 2
  • No more than one line of chemotherapy (concurrent and adjuvant Temozolomide based chemotherapy including in combination with another investigational agent is considered one line of chemotherapy). Chemotherapy must have been completed at least 4 weeks prior to randomization.
  • Post surgery MRI within 48 hours following surgery, however an MRI scan has to be done within 2 weeks prior to randomization.
  • Surgery completed at least 2 weeks before randomization and patients should have fully recovered as assessed by investigators.
  • Renal function: calculated creatinine clearance ≥ 30 mL/min by the Cockcroft-Gault formula.
  • Liver function: bilirubin < 1.5× upper limit of the normal range (ULN), alkaline phosphatase and transaminases (ASAT) < 2.5× ULN

Pediatric sub-study participants (less than 18 years old):

  • Histologically proven high grade glioma (HGG: WHO grade III glioma [e.g anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma], grade IV glioma [e.g glioblastoma, gliosarcoma] or diffuse intrinsic pontine glioma [DIPG]).
  • Must either have recurrent/progressive tumor or, if newly diagnosed, have completed any planned radiation therapy at least 4 weeks prior to first dose of ABT-414.
  • The tumor tissue must have been determined to have EGFR amplification, (by local or other testing service).
  • Availability of adequate biological material for retrospective confirmatory central testing of EGFR amplification
  • Participant has sufficiently recovered from previous therapy. The investigator believes that benefit of treating the pediatric subject with ABT-414 outweighs the expected risks and that this treatment is in the best interests of the pediatric subject.
  • Renal function: calculated creatinine clearance ≥ 30 mL/min by the Cockcroft-Gault formula for pediatric patients ≥12 years of age and estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2 by modified Schwartz equation for pediatric patients < 12 years of age.
  • Liver function: Total bilirubin <= 1.5× upper limit of the normal range (ULN), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) <= 3× ULN. Participants with Gilbert's syndrome documented in medical history may be enrolled if total bilirubin is < 3 times ULN. Not allowed are participants with known chronic liver disease and/or cirrhosis.

Exclusion Criteria:

Adult population (greater than or equal to 18 years old):

  • Prior treatment with nitrosoureas
  • Prior treatment with bevacizumab
  • Previous exposure to Epithelial Growth Factor Receptor (EGFR) targeted agents, including EGFRvIII targeting agents
  • Prior discontinuation of temozolomide chemotherapy for toxicity reasons
  • Prior Radiation Therapy (RT) with a dose over 65 Gy, stereotactic radiosurgery or brachytherapy unless the recurrence is histologically proven
  • Previous other malignancies, except for any previous malignancy which was treated with curative intent more than 5 years prior to randomization, and except for adequately controlled limited basal cell carcinoma of the skin, squamous carcinoma of the skin or carcinoma in situ of the cervix
  • Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to randomization.
  • No history of wheat allergies and Coeliac disease.
  • No EIAED, patients who require anti-convulsant therapy must be taking non-enzyme inducing antiepileptic drugs (non-EIAED). Patients previously on EIAED must be fully switched to non-EIAED at least 2 weeks prior to randomization.

Pediatric sub-study (less than 18 years old):

  • (For recurrent disease) No prior RT with a dose over 65Gy to the brain, stereotactic radiosurgery or brachytherapy unless the recurrence is histologically proven
  • No current or recent (within 4 weeks or 5 half-lives (whichever is shorter) before enrollment) treatment with another investigational drug
  • Female participants of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to randomization.

Information from the National Library of Medicine

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): NCT02343406


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Locations
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United States, California
Lucile Packard Children's Hosp /ID# 153678
Palo Alto, California, United States, 34304
United States, Colorado
Children's Hospital Colorado /ID# 153677
Aurora, Colorado, United States, 80045
Univ of Colorado Cancer Center /ID# 134882
Aurora, Colorado, United States, 80045
Sarah Cannon Research Institute at HealthONE - Denver /ID# 141798
Denver, Colorado, United States, 80218
United States, Illinois
Rush University Medical Center /ID# 137542
Chicago, Illinois, United States, 60612
United States, Massachusetts
Dana-Farber Cancer Institute /ID# 154210
Boston, Massachusetts, United States, 02215
United States, New York
Long Island Brain Tumor Center /ID# 134496
Lake Success, New York, United States, 11042
Columbia Univ Medical Center /ID# 152656
New York, New York, United States, 10032-3725
United States, Ohio
Cleveland Clinic Main Campus /ID# 137540
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pittsburgh MC /ID# 134491
Pittsburgh, Pennsylvania, United States, 15260
United States, Tennessee
Tennessee Oncology, PLLC /ID# 134492
Nashville, Tennessee, United States, 37203
United States, Texas
UT Southwestern Medical Center /ID# 136718
Dallas, Texas, United States, 75390-7208
United States, Washington
Swedish Medical Center /ID# 136719
Seattle, Washington, United States, 98104
Australia, New South Wales
Port Macquarie Base Hospital /ID# 134569
Port Macquarie, New South Wales, Australia, 2444
Sydney Children's Hospital /ID# 153533
Randwick, New South Wales, Australia, 2031
Royal North Shore Hospital /ID# 147092
Saint Leonards, New South Wales, Australia, 2065
Calvary Mater Newcastle /ID# 134570
Waratah, New South Wales, Australia, 2298
Southern Medical Day Care Ctr /ID# 134495
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Royal Brisbane and Women's Hospital /ID# 147091
Herston, Queensland, Australia, 4029
Australia, South Australia
Royal Adelaide Hospital /ID# 135208
Adelaide, South Australia, Australia, 5000
Australia, Tasmania
Royal Hobart Hospital /ID# 135209
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Barwon Health University Hospital Geelong /ID# 134493
Geelong, Victoria, Australia, 3220
Royal Children's Hospital /ID# 157624
Melbourne, Victoria, Australia, 3052
Austria
University Hospital St. Polten /ID# 139070
St. Pölten, Niederoesterreich, Austria, 3100
LKH-Univ. Klinikum Graz /ID# 139071
Graz, Austria, 8036
Keper Universitätsklinikum GmbH - Neuromed Campus /ID# 139068
Linz, Austria, 4020
Belgium
Cliniques Universitaires Saint Luc /ID# 139391
Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
Grand Hôpital de Charleroi /ID# 139342
Charleroi, Hainaut, Belgium, 6000
UZ Gent /ID# 152944
Gent, Oost-Vlaanderen, Belgium, 9000
AZ St-Jan Brugge-Oostende AV /ID# 137927
Brugge, West-Vlaanderen, Belgium, 8000
ZNA Middelheim /ID# 137926
Antwerp, Belgium, 2020
UZ Leuven /ID# 137925
Leuven, Belgium, 3000
Canada, Ontario
Hospital for Sick Children /ID# 202506
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Montreal Neurological Institut /ID# 136309
Montreal, Quebec, Canada, H3A 2B4
Czechia
Fakultni Nemocnice v Motole /ID# 139509
Prague 5, Praha 5, Czechia, 150 06
Masarykuv onkologikcy ustav /ID# 139508
Brno, Czechia, 656 53
FN Hradec Kralove /ID# 139510
Hradec Kralove, Czechia, 500 05
Univ Hosp Ostrava-Poruba /ID# 139507
Ostrava, Czechia, 708 52
Finland
Helsinki Univ Central Hospital /ID# 140078
Helsinki, Finland, 00290
Helsinki Univ Central Hospital /ID# 153069
Helsinki, Finland, 00290
Turku University Hospital /ID# 140861
Turku, Finland, 20520
France
CHRU Lille - Hôpital Claude Huriez /ID# 137916
Lille CEDEX, Hauts-de-France, France, 59045
Centre Oscar Lambret /ID# 169619
Lille, Hauts-de-France, France, 59020
CHU-Hopital Avicenne /ID# 137910
Bobigny, Ile-de-France, France, 93000
Gustave Roussy /ID# 137912
Villejuif, Ile-de-France, France, 94805
Institut de Cancer de l'Ouest /ID# 137914
St Herblain CEDEX, Loire-Atlantique, France, 44805
Hopital de la Timone /ID# 137911
Marseille CEDEX 05, Provence-Alpes-Cote-d Azur, France, 13385
CHU de Nice /ID# 137917
Nice CEDEX 1, Provence-Alpes-Cote-d Azur, France, 06002
Centre Leon Berard /ID# 137918
Lyon CEDEX 08, Rhone, France, 69373
Institut de Cancer de l'Ouest /ID# 137909
Angers, France, 49055
Hospices Civils de Lyon /ID# 137913
Bron, France, 69500
Hopital Pitie Salpetriere /ID# 145887
Paris, France, 75651
Germany
Universitaetsklinik Heidelberg /ID# 137924
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Universitatsklinik Regensburg /ID# 137920
Ratisbon, Bayern, Germany, 93053
Univ Klinik Eppendorf Hamburg /ID# 137921
Hamburg, Germany, 20246
LMU Klinikum der Universität München /ID# 137922
Munich, Germany, 80337
Universitatsklinikum Tubingen /ID# 137923
Tuebingen, Germany, 72076
Hungary
Pecsi Tudomanyegyetem /ID# 136111
Pécs, Pecs, Hungary, 7624
Semmelweis Egyetem /ID# 152578
Budapest, Hungary, 1085
National Institute of Oncology /ID# 135970
Budapest, Hungary, 1122
Orszagos Klinikai Idegtudomany /ID# 135971
Budapest, Hungary, 1145
Debreceni Egyetem Klinikai Koz /ID# 135969
Debrecen, Hungary, 4032
Ireland
Cork University Hospital /ID# 136828
Cork, Ireland, T12 E8YV
Beaumont Hospital /ID# 136829
Dublin, Ireland, D09 XR63
Italy
Ospedale Bellaria.Azienda USL IRCCS.Istituto delle Scienze Neurologiche di Bolog /ID# 138335
Bologna, Italy, 40139
Ospedale Generale di Bolzano /ID# 138338
Bolzano, Italy, 39100
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 140395
Milan, Italy, 20133
Istituto Oncologico Veneto /ID# 138336
Padova, Italy, 35128
Azienda Ospedaliera Sant' Andrea /ID# 138337
Rome, Italy, 00189
Korea, Republic of
Seoul National Univ Bundang ho /ID# 136841
Seongnam, Gyeonggido, Korea, Republic of, 13620
Samsung Medical Center /ID# 136842
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Seoul National University Hospital /ID# 136840
Seoul, Korea, Republic of, 03080
Netherlands
Vrije Universiteit Medisch Centrum /ID# 137221
Amsterdam, Netherlands, 1081 HV
Universitair Medisch Centrum Groningen /ID# 138266
Groningen, Netherlands, 9713 GZ
Erasmus Medisch Centrum /ID# 136981
Rotterdam, Netherlands, 3015 CE
Haaglanden Medisch Centrum /ID# 137222
The Hague, Netherlands, 2512 VA
Universitair Medisch Centrum Utrecht /ID# 137219
Utrecht, Netherlands, 3584 CX
Prinses Maxima Centrum /ID# 204409
Utrecht, Netherlands, 3584 EA
Poland
Uniwersyteckie Centrum Kliniczne /ID# 137919
Gdansk, Mazowieckie, Poland, 80-214
Wojewodzkie Wielospecjalistycz /ID# 137654
Lodz, Poland, 93-509
Singapore
National University Hospital /ID# 135951
Singapore, Singapore, 119074
National Cancer Ctr Singapore /ID# 135952
Singapore, Singapore, 169610
KK Women's & Children Hospital /ID# 153676
Singapore, Singapore, 229899
Spain
Clinica Universitar de Navarra - Pamplona /ID# 140047
Pamplona, Navarra, Comunidad, Spain, 31008
Instituto Catalan de Oncologia (ICO) /ID# 140976
Barcelona, Spain, 08016
Instituto Catalan de Oncologia (ICO) & Hosp. de Bellvitge /ID# 137688
Barcelona, Spain, 08908
Hospital Universitario Nino /ID# 153800
Madrid, Spain, 28009
Hosp Univ 12 de Octubre /ID# 137908
Madrid, Spain, 28041
Switzerland
Centre Hospitalier Univ Vaudoi /ID# 137929
Lausanne, Switzerland, 1011
University Hospital Zurich /ID# 137930
Zurich, Switzerland, 8091
Taiwan
China Medical University Hosp /ID# 136976
Taichung City, Taichung, Taiwan, 40447
National Taiwan Univ Hosp /ID# 136975
Taipei City, Taipei, Taiwan, 10002
Taichung Veterans General Hosp /ID# 136977
Taichung City, Taiwan, 40705
Taipei Veterans General Hosp /ID# 136974
Taipei City, Taiwan, 11217
Linkou Chang Gung Memorial Ho /ID# 136944
Taoyuan City, Taiwan, 33305
United Kingdom
Guy's and St Thomas' NHS Found /ID# 140312
London, London, City Of, United Kingdom, SE1 9RT
Univ Hospitals Birmingham NHS Foundation trust /ID# 136978
Birmingham, United Kingdom, B15 2TG
Gartnavel General Hospital /ID# 136979
Glasgow, United Kingdom, G12 0YN
Hull and East Yorkshire NHS /ID# 136917
Hull, United Kingdom, HU8 9HE
University College Hospitals /ID# 136879
London, United Kingdom, NW1 2BU
Great Ormond St Hospital NHS /ID# 153421
London, United Kingdom, WC1N 3JH
Christie NHS Foundation Trust /ID# 140313
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
AbbVie
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
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Study Director: AbbVie Inc. AbbVie

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02343406     History of Changes
Other Study ID Numbers: M14-483
2014-004438-24 ( EudraCT Number )
EORTC 1410-BTG ( Other Grant/Funding Number: European Organization for Research and Treatment of Cancer (EORTC) )
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019
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)
Analytic Code
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

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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:
Glioblastoma Multiforme
Epithelial Growth Factor vIII mutation
Temozolomide
Lomustine
ABT-414
European Organization for Research and Treatment of Cancer
recurrent glioblastoma
Epithelial Growth Factor
Brain Tumor
Brain Tumor Group
Antibody Drug Conjugate
EORTC
Pediatric High Grade Gliomas
Pediatric diffuse Intrinsic Pontine Glioma
Pediatric WHO grade III glioma
Pediatric WHO grade IV glioma
EGFR amplification
Children

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