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: ABT-414 Alone or ABT-414 Plus Temozolomide Versus Lomustine or Temozolomide for Recurrent Glioblastoma: A Randomized Phase 2 Study of the EORTC Brain Tumor Group
3 other identifiers
interventional
266
20 countries
99
Brief Summary
This study was conducted to evaluate the efficacy and safety of depatuxizumab mafodotin (ABT-414) alone or with temozolomide versus temozolomide or lomustine alone in adult participants with recurrent glioblastoma. The study also included a substudy to evaluate safety, tolerability and pharmacokinetics of ABT-414 in a pediatric population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2015
Typical duration for phase_2
99 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2014
CompletedFirst Posted
Study publicly available on registry
January 22, 2015
CompletedStudy Start
First participant enrolled
February 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2019
CompletedResults Posted
Study results publicly available
May 22, 2020
CompletedMay 22, 2020
May 1, 2020
4.4 years
December 22, 2014
March 30, 2020
May 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Adult Study: Overall Survival (OS)
Overall Survival (OS) was defined as time from randomization to death due to any cause, regardless of whether the event occurred on or off study drug (depatuxizumab mafodotin/temozolomide/lomustine).
From the date of randomization up to the date of participant's death; participants who completed treatment were to be assessed every 12 weeks, up to 28 months.
Adult Study: Progression-Free Survival (PFS)
Progression-free survival was assessed per response assessment in neuro-oncology criteria (RANO) criteria and assessed by an independent review committee and was defined as the length of time during and after the treatment of a disease, that the participant lived with the disease but did not get worse.
Measured every 8 weeks from date of randomization until the date of first objective progression or subject's death, whichever occurred first, up to 2 years
Pediatric Study: Percentage of Participants With Adverse Events From the First Visit Until 49 Days After the Last Dose of Study Drug
The severity of each adverse event was rated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 4.0)
From participant's first visit until 49 days after the participant's last dose of study drug, up to 63 weeks
Pediatric Study: Maximum Observed Serum Concentration (Cmax) of ABT-414
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.
Samples collected Cycle 1 Days 1, 2,3,5,8,15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 5 Day 1; Day 1 of every two cycles starting with Cycle 5; and 35 days after the last dose
Pediatric Study: Maximum Observed Plasma Concentration (Cmax) of Cys-mcMMAF
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. Cys-mcMMAF is a toxic metabolite of depatuxizumab mafodotin.
Samples collected Cycle 1 Days 1, 2, 3, 5, 8
Pediatric Study: Half-life (t1/2) Observed for ABT-414
Half-life is the calculated time it takes for half of the drug to leave the body.
Samples collected Cycle 1 Days 1, 2,3,5,8,15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 5 Day 1; Day 1 of every two cycles starting with Cycle 5; and 35 days after the last dose
Pediatric Study: Half-life (t1/2) Observed for Cys-mcMMAF
Half-life is the calculated time it takes for half of the drug or drug metabolite to leave the body. CysmcMMAF is a toxic metabolite of depatuxizumab mafodotin.
Samples collected Cycle 1 Days 1, 2, 3, 5, 8
Pediatric Study: Area Under the Concentration-time Curve (AUC) Observed for ABT-414
AUC is a measure of how long and how much drug is present in the body after dosing. The AUC of depatuxizumab mafodotin (ABT-414) in the pediatric population was measured following treatment to confirm that this was comparable to adults, and that the dosing levels are appropriate for a pediatric population.
Samples collected Cycle 1 Days 1, 2,3,5,8,15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 5 Day 1; Day 1 of every two cycles starting with Cycle 5; and 35 days after the last dose
Pediatric Study: Area Under the Concentration-time-curve (AUC) Observed for Unconjugated Cys-mcMMAF
AUC is a measure of how long and how much drug or drug metabolite is present in the body after dosing. The AUC of Cys-mcMMAF, a toxic metabolite of depatuxizumab mafodotin, in the pediatric population was measured following treatment to confirm that this was comparable to adults, and that the dosing levels are appropriate for a pediatric population.
Samples collected Cycle 1 Days 1, 2, 3, 5, 8
Secondary Outcomes (9)
Adult Study: Objective Response Rate (ORR)
Every 8 weeks at each assessment of disease, up to 28 months
Adult Study: Overall Survival in the Subgroup With Epidermal Growth Factor Receptor (EGFRvIII) Mutation
From the date of randomization up to the date of participant's death; participants who completed treatment were to be assessed every 12 weeks, up to 28 months
Pediatric Study: Objective Response Rate (ORR)
Evaluated every 8 weeks (+/- 7 days) at each assessment of disease according to response assessment in neuro-oncology criteria (RANO), until progression or withdrawal up to approximately 52 weeks
Pediatric Study: Best Tumor Response Rate
Evaluated every 8 weeks (+/- 7 days) at each assessment of disease according to response assessment in neuro-oncology criteria (RANO), until progression or withdrawal up to approximately 52 weeks
Pediatric Study: Duration of Response
Evaluated every 8 weeks (+/- 7 days) at each assessment of disease according to response assessment in neuro-oncology criteria (RANO), until progression or withdrawal up to approximately 52 weeks
- +4 more secondary outcomes
Study Arms (5)
ABT-414/temozolomide
EXPERIMENTALDepatuxizumab mafodotin (ABT-414) administered once every 2 weeks in combination with temozolomide (TMZ) to adult participants
ABT-414_adult
EXPERIMENTALDepatuxizumab mafodotin (ABT-414) administered once every 2 weeks to adult participants
Control_lomustine
ACTIVE COMPARATORAdult participants relapsing during temozolomide (TMZ) treatment or within the first 16 weeks after the first day of the last TMZ cycle received lomustine on Day 1 of every 42-day treatment period until one of the treatment withdrawal criteria was met, up to a maximum of 1 year.
Control_ temozolomide
ACTIVE COMPARATORAdult participants relapsing 16 weeks or more after the first day of the last temozolomide (TMZ) cycle received TMZ on Day 1 to Day 5 for the first 28-day cycle, with dose escalation in subsequent cycles in case of adequate tolerance and treatment continuing until one of the treatment withdrawal criteria was met.
ABT-414_ pediatric
EXPERIMENTALDepatuxizumab mafodotin (ABT-414) administered once every 2 weeks to pediatric participants. Temozolomide (TMZ) was only allowed for pediatric participants if its use was in accordance with local clinical practice, and was not considered an investigational product for the study (unless this was a local requirement).
Interventions
Adults: intravenous administration (1.25 mg/kg or 1.0 mg/kg body weight) over 30 to 40 minutes once every 2 weeks until one of the treatment withdrawal criteria was met. The dose was 1.25 mg/kg in the original protocol (Version 1) and Version 2, Amendment 1, and was lowered to 1.0 mg/kg in protocol Version 3, Amendment 2. Pediatric participants: Intravenous administration (1.0 mg/kg body weight for those who were 6 to 17 years old at the date of first dose, or 1.3 mg/kg for those who were 0 to 5 years old) over 30 to 40 minutes or as directed by the guidelines once every 2 weeks until one of the treatment withdrawal criteria was met, for a maximum of one year. If used in combination with temozolomide, depatuxizumab mafodotin was dosed on Day 1 and Day 15 of the TMZ cycle (assuming a standard regimen of 200 mg/m\^2/day for 5 days of each 28-day cycle; for other TMZ schedules, timing of the depatuxizumab mafodotin dosing schedule were to be discussed with the medical monitor).
Capsules administered orally, 150 mg/m\^2 on Days 1-5 for the first 28-day cycle, with dose escalation to 200 mg/m\^2 in subsequent cycles in case of adequate tolerance until one of the treatment withdrawal criteria was met.
Capsules administered orally, 110 mg/m\^2 on Day 1 of every 42-day treatment period. Treatment continued until one of the treatment withdrawal criteria was met, for a maximum of one year.
Eligibility Criteria
You may qualify if:
- Adult participants (greater than or equal to 18 years old):
- Histologically confirmed de novo (primary) glioblastoma 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.
- +5 more criteria
You may not qualify if:
- 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 to the brain, 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 65 Gy 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (102)
Lucile Packard Children's Hosp /ID# 153678
Palo Alto, California, 34304, United States
Children's Hospital Colorado /ID# 153677
Aurora, Colorado, 80045, United States
Univ of Colorado Cancer Center /ID# 134882
Aurora, Colorado, 80045, United States
Sarah Cannon Research Institute at HealthONE - Denver /ID# 141798
Denver, Colorado, 80218, United States
Rush University Medical Center /ID# 137542
Chicago, Illinois, 60612, United States
Dana-Farber Cancer Institute /ID# 154210
Boston, Massachusetts, 02215, United States
Long Island Brain Tumor Center /ID# 134496
Lake Success, New York, 11042, United States
Weill Cornell Medicine /ID# 152656
New York, New York, 10032-3725, United States
Cleveland Clinic Main Campus /ID# 137540
Cleveland, Ohio, 44195, United States
University of Pittsburgh MC /ID# 134491
Pittsburgh, Pennsylvania, 15260, United States
Tennessee Oncology, PLLC /ID# 134492
Nashville, Tennessee, 37203, United States
UT Southwestern Medical Center /ID# 136718
Dallas, Texas, 75390-7208, United States
Swedish Medical Center /ID# 136719
Seattle, Washington, 98104, United States
Port Macquarie Base Hospital /ID# 134569
Port Macquarie, New South Wales, 2444, Australia
Sydney Children's Hospital /ID# 153533
Randwick, New South Wales, 2031, Australia
Royal North Shore Hospital /ID# 147092
Saint Leonards, New South Wales, 2065, Australia
Calvary Mater Newcastle /ID# 134570
Waratah, New South Wales, 2298, Australia
Southern Medical Day Care Ctr /ID# 134495
Wollongong, New South Wales, 2500, Australia
Royal Brisbane and Women's Hospital /ID# 147091
Herston, Queensland, 4029, Australia
Royal Adelaide Hospital /ID# 135208
Adelaide, South Australia, 5000, Australia
Royal Hobart Hospital /ID# 135209
Hobart, Tasmania, 7000, Australia
Barwon Health University Hospital Geelong /ID# 134493
Geelong, Victoria, 3220, Australia
Royal Children's Hospital /ID# 157624
Melbourne, Victoria, 3052, Australia
University Hospital St. Polten /ID# 139070
Sankt Pölten, Lower Austria, 3100, Austria
LKH-Univ. Klinikum Graz /ID# 139071
Graz, 8036, Austria
Kepler Universitätsklinikum GmbH - Neuromed Campus /ID# 139068
Linz, 4020, Austria
Cliniques Universitaires Saint Luc /ID# 139391
Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium
Grand Hôpital de Charleroi /ID# 139342
Charleroi, Hainaut, 6000, Belgium
UZ Gent /ID# 152944
Ghent, Oost-Vlaanderen, 9000, Belgium
AZ St-Jan Brugge-Oostende AV /ID# 137927
Bruges, West-Vlaanderen, 8000, Belgium
ZNA Middelheim /ID# 137926
Antwerp, 2020, Belgium
UZ Leuven /ID# 137925
Leuven, 3000, Belgium
Montreal Neurological Institut /ID# 136309
Montreal, Quebec, H3A 2B4, Canada
Fakultni Nemocnice v Motole /ID# 139509
Prague, Praha 5, 150 06, Czechia
Masarykuv onkologikcy ustav /ID# 139508
Brno, 656 53, Czechia
FN Hradec Kralove /ID# 139510
Hradec Králové, 500 05, Czechia
Univ Hosp Ostrava-Poruba /ID# 139507
Ostrava, 708 52, Czechia
Helsinki Univ Central Hospital /ID# 140078
Helsinki, 00290, Finland
Helsinki Univ Central Hospital /ID# 153069
Helsinki, 00290, Finland
Turku University Hospital /ID# 140861
Turku, 20520, Finland
Centre Oscar Lambret /ID# 169619
Lille, Hauts-de-France, 59020, France
CHRU Lille - Hôpital Claude Huriez /ID# 137916
Lille, Hauts-de-France, 59045, France
Institut de Cancer de l'Ouest /ID# 137914
Saint-Herblain, Loire-Atlantique, 44805, France
Hopital de la Timone /ID# 137911
Marseille, Provence-Alpes-Côte d'Azur Region, 13385, France
CHU de Nice /ID# 137917
Nice, Provence-Alpes-Côte d'Azur Region, 06002, France
Centre Leon Berard /ID# 137918
Lyon, Rhone, 69373, France
Institut de Cancer de l'Ouest /ID# 137909
Angers, 49055, France
Hospices Civils de Lyon /ID# 137913
Bron, 69500, France
Hopital Pitie Salpetriere /ID# 145887
Paris, 75651, France
CHU-Hopital Avicenne /ID# 137910
Bobigny, Île-de-France Region, 93000, France
Gustave Roussy /ID# 137912
Villejuif, Île-de-France Region, 94805, France
Universitaetsklinik Heidelberg /ID# 137924
Heidelberg, Baden-Wurttemberg, 69120, Germany
Universitatsklinik Regensburg /ID# 137920
Regensburg, Bavaria, 93053, Germany
Univ Klinik Eppendorf Hamburg /ID# 137921
Hamburg, 20246, Germany
LMU Klinikum der Universität München /ID# 137922
Munich, 80337, Germany
Universitatsklinikum Tubingen /ID# 137923
Tübingen, 72076, Germany
Pecsi Tudomanyegyetem /ID# 136111
Pécs, Pecs, 7624, Hungary
Semmelweis Egyetem /ID# 152578
Budapest, 1085, Hungary
National Institute of Oncology /ID# 135970
Budapest, 1122, Hungary
Orszagos Klinikai Idegtudomany /ID# 135971
Budapest, 1145, Hungary
Debreceni Egyetem Klinikai Központ /ID# 135969
Debrecen, 4032, Hungary
Cork University Hospital /ID# 136828
Cork, T12 E8YV, Ireland
Beaumont Hospital /ID# 136829
Dublin, D09 XR63, Ireland
Ospedale Bellaria.Azienda USL IRCCS.Istituto delle Scienze Neurologiche di Bolog /ID# 138335
Bologna, 40139, Italy
Ospedale Generale di Bolzano /ID# 138338
Bolzano, 39100, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 140395
Milan, 20133, Italy
Istituto Oncologico Veneto /ID# 138336
Padua, 35128, Italy
Azienda Ospedaliera Sant' Andrea /ID# 138337
Rome, 00189, Italy
Hospital Zambrano Hellion /ID# 138076
San Pedro Garza García, 66278, Mexico
Vrije Universiteit Medisch Centrum /ID# 137221
Amsterdam, 1081 HV, Netherlands
Universitair Medisch Centrum Groningen /ID# 138266
Groningen, 9713 GZ, Netherlands
Erasmus Medisch Centrum /ID# 136981
Rotterdam, 3015 CE, Netherlands
Haaglanden Medisch Centrum /ID# 137222
The Hague, 2512 VA, Netherlands
Universitair Medisch Centrum Utrecht /ID# 137219
Utrecht, 3584 CX, Netherlands
Prinses Maxima Centrum /ID# 204409
Utrecht, 3584 EA, Netherlands
Uniwersyteckie Centrum Kliniczne /ID# 137919
Gdansk, Masovian Voivodeship, 80-214, Poland
Wojewodzkie Wielospecjalistycz /ID# 137654
Lodz, 93-509, Poland
National University Hospital /ID# 135951
Singapore, 119074, Singapore
National Cancer Ctr Singapore /ID# 135952
Singapore, 169610, Singapore
KK Women's & Children Hospital /ID# 153676
Singapore, 229899, Singapore
Seoul National Univ Bundang ho /ID# 136841
Seongnam, Gyeonggido, 13620, South Korea
Samsung Medical Center /ID# 136842
Seoul, Seoul Teugbyeolsi, 06351, South Korea
Seoul National University Hospital /ID# 136840
Seoul, 03080, South Korea
Instituto Catalán de Oncología (ICO) Badalona /ID# 140976
Badalona, Barcelona, 08916, Spain
Clinica Universitar de Navarra - Pamplona /ID# 140047
Pamplona, Navarra, Comunidad, 31008, Spain
Instituto Catalan de Oncologia (ICO) & Hosp. de Bellvitge /ID# 137688
Barcelona, 08908, Spain
Hospital Universitario Nino /ID# 153800
Madrid, 28009, Spain
Hosp Univ 12 de Octubre /ID# 137908
Madrid, 28041, Spain
Centre Hospitalier Univ Vaudoi /ID# 137929
Lausanne, 1011, Switzerland
University Hospital Zurich /ID# 137930
Zurich, 8091, Switzerland
China Medical University Hosp /ID# 136976
Taichung, Taichung, 40447, Taiwan
National Taiwan Univ Hosp /ID# 136975
Taipei City, Taipei, 10002, Taiwan
Taichung Veterans General Hosp /ID# 136977
Taichung, 40705, Taiwan
Taipei Veterans General Hosp /ID# 136974
Taipei, 11217, Taiwan
Linkou Chang Gung Memorial Ho /ID# 136944
Taoyuan, 33305, Taiwan
Guy's and St Thomas' NHS Found /ID# 140312
London, London, City of, SE1 9RT, United Kingdom
Univ Hospitals Birmingham NHS Foundation trust /ID# 136978
Birmingham, B15 2TG, United Kingdom
Gartnavel General Hospital /ID# 136979
Glasgow, G12 0YN, United Kingdom
Hull and East Yorkshire NHS /ID# 136917
Hull, HU8 9HE, United Kingdom
University College Hospitals /ID# 136879
London, NW1 2BU, United Kingdom
Great Ormond St Hospital NHS /ID# 153421
London, WC1N 3JH, United Kingdom
Christie NHS Foundation Trust /ID# 140313
Manchester, M20 4BX, United Kingdom
Related Publications (5)
Clement PMJ, Dirven L, Eoli M, Sepulveda-Sanchez JM, Walenkamp AME, Frenel JS, Franceschi E, Weller M, Chinot O, De Vos FYFL, Whenham N, Sanghera P, Looman J, Kundu MG, Peter de Geus J, Nuyens S, Spruyt M, Gorlia T, Coens C, Golfinopoulos V, Reijneveld JC, van den Bent MJ. Impact of depatuxizumab mafodotin on health-related quality of life and neurological functioning in the phase II EORTC 1410/INTELLANCE 2 trial for EGFR-amplified recurrent glioblastoma. Eur J Cancer. 2021 Apr;147:1-12. doi: 10.1016/j.ejca.2021.01.010. Epub 2021 Feb 15.
PMID: 33601293DERIVEDVan Den Bent M, Eoli M, Sepulveda JM, Smits M, Walenkamp A, Frenel JS, Franceschi E, Clement PM, Chinot O, De Vos F, Whenham N, Sanghera P, Weller M, Dubbink HJ, French P, Looman J, Dey J, Krause S, Ansell P, Nuyens S, Spruyt M, Brilhante J, Coens C, Gorlia T, Golfinopoulos V. INTELLANCE 2/EORTC 1410 randomized phase II study of Depatux-M alone and with temozolomide vs temozolomide or lomustine in recurrent EGFR amplified glioblastoma. Neuro Oncol. 2020 May 15;22(5):684-693. doi: 10.1093/neuonc/noz222.
PMID: 31747009DERIVEDLassman AB, van den Bent MJ, Gan HK, Reardon DA, Kumthekar P, Butowski N, Lwin Z, Mikkelsen T, Nabors LB, Papadopoulos KP, Penas-Prado M, Simes J, Wheeler H, Walbert T, Scott AM, Gomez E, Lee HJ, Roberts-Rapp L, Xiong H, Ansell PJ, Bain E, Holen KD, Maag D, Merrell R. Safety and efficacy of depatuxizumab mafodotin + temozolomide in patients with EGFR-amplified, recurrent glioblastoma: results from an international phase I multicenter trial. Neuro Oncol. 2019 Jan 1;21(1):106-114. doi: 10.1093/neuonc/noy091.
PMID: 29982805DERIVEDGan HK, Reardon DA, Lassman AB, Merrell R, van den Bent M, Butowski N, Lwin Z, Wheeler H, Fichtel L, Scott AM, Gomez EJ, Fischer J, Mandich H, Xiong H, Lee HJ, Munasinghe WP, Roberts-Rapp LA, Ansell PJ, Holen KD, Kumthekar P. Safety, pharmacokinetics, and antitumor response of depatuxizumab mafodotin as monotherapy or in combination with temozolomide in patients with glioblastoma. Neuro Oncol. 2018 May 18;20(6):838-847. doi: 10.1093/neuonc/nox202.
PMID: 29077941DERIVEDReardon DA, Lassman AB, van den Bent M, Kumthekar P, Merrell R, Scott AM, Fichtel L, Sulman EP, Gomez E, Fischer J, Lee HJ, Munasinghe W, Xiong H, Mandich H, Roberts-Rapp L, Ansell P, Holen KD, Gan HK. Efficacy and safety results of ABT-414 in combination with radiation and temozolomide in newly diagnosed glioblastoma. Neuro Oncol. 2017 Jul 1;19(7):965-975. doi: 10.1093/neuonc/now257.
PMID: 28039367DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2014
First Posted
January 22, 2015
Study Start
February 17, 2015
Primary Completion
June 24, 2019
Study Completion
June 24, 2019
Last Updated
May 22, 2020
Results First Posted
May 22, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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.