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

NCT ID: NCT02343406

Last Updated: 2020-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-17
• Study Completion Date: 2019-06-24

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.

Detailed Description

The study objectives were to assess whether depatuxizumab mafodotin (ABT-414) alone or in combination with temozolomide (TMZ) improved overall survival (OS), progression-free survival (PFS), tumor response, quality of life, neurological deterioration-free survival (NDFS), and steroid use compared to standard treatment with lomustine single agent or TMZ re-challenge in adult subjects ≥ 18 years of age with centrally-confirmed recurrent epidermal growth factor receptor (EGFR)-amplified glioblastoma. The safety, pharmacokinetics, and efficacy of depatuxizumab mafodotin in children <18 years of age was evaluated in a pediatric substudy. The EMEA-001732-PIP02-15 pediatric investigation plan was withdrawn on 07 July 2019 due to the discontinuation of the depatuxizumab mafodotin research program.

Conditions

Glioblastoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ABT-414/temozolomide

Depatuxizumab mafodotin (ABT-414) administered once every 2 weeks in combination with temozolomide (TMZ) to adult participants

Group Type: EXPERIMENTAL

Depatuxizumab mafodotin

Intervention Type: DRUG

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).

Temozolomide

Intervention Type: DRUG

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.

ABT-414_adult

Depatuxizumab mafodotin (ABT-414) administered once every 2 weeks to adult participants

Group Type: EXPERIMENTAL

Depatuxizumab mafodotin

Intervention Type: DRUG

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).

Control_lomustine

Adult 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.

Group Type: ACTIVE_COMPARATOR

Lomustine

Intervention Type: DRUG

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.

Control_ temozolomide

Adult 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.

Group Type: ACTIVE_COMPARATOR

Temozolomide

Intervention Type: DRUG

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.

ABT-414_ pediatric

Depatuxizumab 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).

Group Type: EXPERIMENTAL

Depatuxizumab mafodotin

Intervention Type: DRUG

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).

Interventions

Depatuxizumab mafodotin

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).

Intervention Type: DRUG

Temozolomide

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.

Intervention Type: DRUG

Lomustine

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.

Intervention Type: DRUG

Other Intervention Names

ABT-414; TMZ; Gleostine

Eligibility Criteria

Inclusion Criteria

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.
• 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 m^2 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 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.

• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: collaborator

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

Lucile Packard Children's Hosp /ID# 153678

Palo Alto, California, United States

Children's Hospital Colorado /ID# 153677

Aurora, Colorado, United States

Univ of Colorado Cancer Center /ID# 134882

Aurora, Colorado, United States

Sarah Cannon Research Institute at HealthONE - Denver /ID# 141798

Denver, Colorado, United States

Rush University Medical Center /ID# 137542

Chicago, Illinois, United States

Dana-Farber Cancer Institute /ID# 154210

Boston, Massachusetts, United States

Long Island Brain Tumor Center /ID# 134496

Lake Success, New York, United States

Weill Cornell Medicine /ID# 152656

New York, New York, United States

Cleveland Clinic Main Campus /ID# 137540

Cleveland, Ohio, United States

University of Pittsburgh MC /ID# 134491

Pittsburgh, Pennsylvania, United States

Tennessee Oncology, PLLC /ID# 134492

Nashville, Tennessee, United States

UT Southwestern Medical Center /ID# 136718

Dallas, Texas, United States

Swedish Medical Center /ID# 136719

Seattle, Washington, United States

Port Macquarie Base Hospital /ID# 134569

Port Macquarie, New South Wales, Australia

Sydney Children's Hospital /ID# 153533

Randwick, New South Wales, Australia

Royal North Shore Hospital /ID# 147092

Saint Leonards, New South Wales, Australia

Calvary Mater Newcastle /ID# 134570

Waratah, New South Wales, Australia

Southern Medical Day Care Ctr /ID# 134495

Wollongong, New South Wales, Australia

Royal Brisbane and Women's Hospital /ID# 147091

Herston, Queensland, Australia

Royal Adelaide Hospital /ID# 135208

Adelaide, South Australia, Australia

Royal Hobart Hospital /ID# 135209

Hobart, Tasmania, Australia

Barwon Health University Hospital Geelong /ID# 134493

Geelong, Victoria, Australia

Royal Children's Hospital /ID# 157624

Melbourne, Victoria, Australia

University Hospital St. Polten /ID# 139070

Sankt Pölten, Lower Austria, Austria

LKH-Univ. Klinikum Graz /ID# 139071

Graz, , Austria

Kepler Universitätsklinikum GmbH - Neuromed Campus /ID# 139068

Linz, , Austria

Cliniques Universitaires Saint Luc /ID# 139391

Woluwe-Saint-Lambert, Brussels Capital, Belgium

Grand Hôpital de Charleroi /ID# 139342

Charleroi, Hainaut, Belgium

UZ Gent /ID# 152944

Ghent, Oost-Vlaanderen, Belgium

AZ St-Jan Brugge-Oostende AV /ID# 137927

Bruges, West-Vlaanderen, Belgium

ZNA Middelheim /ID# 137926

Antwerp, , Belgium

UZ Leuven /ID# 137925

Leuven, , Belgium

Montreal Neurological Institut /ID# 136309

Montreal, Quebec, Canada

Fakultni Nemocnice v Motole /ID# 139509

Prague, Praha 5, Czechia

Masarykuv onkologikcy ustav /ID# 139508

Brno, , Czechia

FN Hradec Kralove /ID# 139510

Hradec Králové, , Czechia

Univ Hosp Ostrava-Poruba /ID# 139507

Ostrava, , Czechia

Helsinki Univ Central Hospital /ID# 140078

Helsinki, , Finland

Helsinki Univ Central Hospital /ID# 153069

Helsinki, , Finland

Turku University Hospital /ID# 140861

Turku, , Finland

Centre Oscar Lambret /ID# 169619

Lille, Hauts-de-France, France

CHRU Lille - Hôpital Claude Huriez /ID# 137916

Lille, Hauts-de-France, France

Institut de Cancer de l'Ouest /ID# 137914

Saint-Herblain, Loire-Atlantique, France

Hopital de la Timone /ID# 137911

Marseille, Provence-Alpes-Côte d'Azur Region, France

CHU de Nice /ID# 137917

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

Centre Leon Berard /ID# 137918

Lyon, Rhone, France

Institut de Cancer de l'Ouest /ID# 137909

Angers, , France

Hospices Civils de Lyon /ID# 137913

Bron, , France

Hopital Pitie Salpetriere /ID# 145887

Paris, , France

CHU-Hopital Avicenne /ID# 137910

Bobigny, Île-de-France Region, France

Gustave Roussy /ID# 137912

Villejuif, Île-de-France Region, France

Universitaetsklinik Heidelberg /ID# 137924

Heidelberg, Baden-Wurttemberg, Germany

Universitatsklinik Regensburg /ID# 137920

Regensburg, Bavaria, Germany

Univ Klinik Eppendorf Hamburg /ID# 137921

Hamburg, , Germany

LMU Klinikum der Universität München /ID# 137922

Munich, , Germany

Universitatsklinikum Tubingen /ID# 137923

Tübingen, , Germany

Pecsi Tudomanyegyetem /ID# 136111

Pécs, Pecs, Hungary

Semmelweis Egyetem /ID# 152578

Budapest, , Hungary

National Institute of Oncology /ID# 135970

Budapest, , Hungary

Orszagos Klinikai Idegtudomany /ID# 135971

Budapest, , Hungary

Debreceni Egyetem Klinikai Központ /ID# 135969

Debrecen, , Hungary

Cork University Hospital /ID# 136828

Cork, , Ireland

Beaumont Hospital /ID# 136829

Dublin, , Ireland

Ospedale Bellaria.Azienda USL IRCCS.Istituto delle Scienze Neurologiche di Bolog /ID# 138335

Bologna, , Italy

Ospedale Generale di Bolzano /ID# 138338

Bolzano, , Italy

Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 140395

Milan, , Italy

Istituto Oncologico Veneto /ID# 138336

Padua, , Italy

Azienda Ospedaliera Sant' Andrea /ID# 138337

Rome, , Italy

Hospital Zambrano Hellion /ID# 138076

San Pedro Garza García, , Mexico

Vrije Universiteit Medisch Centrum /ID# 137221

Amsterdam, , Netherlands

Universitair Medisch Centrum Groningen /ID# 138266

Groningen, , Netherlands

Erasmus Medisch Centrum /ID# 136981

Rotterdam, , Netherlands

Haaglanden Medisch Centrum /ID# 137222

The Hague, , Netherlands

Universitair Medisch Centrum Utrecht /ID# 137219

Utrecht, , Netherlands

Prinses Maxima Centrum /ID# 204409

Utrecht, , Netherlands

Uniwersyteckie Centrum Kliniczne /ID# 137919

Gdansk, Masovian Voivodeship, Poland

Wojewodzkie Wielospecjalistycz /ID# 137654

Lodz, , Poland

National University Hospital /ID# 135951

Singapore, , Singapore

National Cancer Ctr Singapore /ID# 135952

Singapore, , Singapore

KK Women's & Children Hospital /ID# 153676

Singapore, , Singapore

Seoul National Univ Bundang ho /ID# 136841

Seongnam, Gyeonggido, South Korea

Samsung Medical Center /ID# 136842

Seoul, Seoul Teugbyeolsi, South Korea

Seoul National University Hospital /ID# 136840

Seoul, , South Korea

Instituto Catalán de Oncología (ICO) Badalona /ID# 140976

Badalona, Barcelona, Spain

Clinica Universitar de Navarra - Pamplona /ID# 140047

Pamplona, Navarra, Comunidad, Spain

Instituto Catalan de Oncologia (ICO) & Hosp. de Bellvitge /ID# 137688

Barcelona, , Spain

Hospital Universitario Nino /ID# 153800

Madrid, , Spain

Hosp Univ 12 de Octubre /ID# 137908

Madrid, , Spain

Centre Hospitalier Univ Vaudoi /ID# 137929

Lausanne, , Switzerland

University Hospital Zurich /ID# 137930

Zurich, , Switzerland

China Medical University Hosp /ID# 136976

Taichung, Taichung, Taiwan

National Taiwan Univ Hosp /ID# 136975

Taipei City, Taipei, Taiwan

Taichung Veterans General Hosp /ID# 136977

Taichung, , Taiwan

Taipei Veterans General Hosp /ID# 136974

Taipei, , Taiwan

Linkou Chang Gung Memorial Ho /ID# 136944

Taoyuan, , Taiwan

Guy's and St Thomas' NHS Found /ID# 140312

London, London, City of, United Kingdom

Univ Hospitals Birmingham NHS Foundation trust /ID# 136978

Birmingham, , United Kingdom

Gartnavel General Hospital /ID# 136979

Glasgow, , United Kingdom

Hull and East Yorkshire NHS /ID# 136917

Hull, , United Kingdom

University College Hospitals /ID# 136879

London, , United Kingdom

Great Ormond St Hospital NHS /ID# 153421

London, , United Kingdom

Christie NHS Foundation Trust /ID# 140313

Manchester, , United Kingdom

Countries

United States; Australia; Austria; Belgium; Canada; Czechia; Finland; France; Germany; Hungary; Ireland; Italy; Mexico; Netherlands; Poland; Singapore; South Korea; Spain; Switzerland; Taiwan; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 33601293 (View on PubMed)

Van 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.

Reference Type: DERIVED

PMID: 31747009 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29982805 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29077941 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28039367 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2014-004438-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EORTC 1410-BTG

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

M14-483

Identifier Type: -

Identifier Source: org_study_id