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dc.contributor.authorGan, Hui K-
dc.contributor.authorReardon, David A-
dc.contributor.authorLassman, Andrew B-
dc.contributor.authorMerrell, Ryan-
dc.contributor.authorvan den Bent, Martin-
dc.contributor.authorButowski, Nicholas-
dc.contributor.authorLwin, Zarnie-
dc.contributor.authorWheeler, Helen-
dc.contributor.authorFichtel, Lisa-
dc.contributor.authorScott, Andrew M-
dc.contributor.authorGomez, Erica J-
dc.contributor.authorFischer, JuDee-
dc.contributor.authorMandich, Helen-
dc.contributor.authorXiong, Hao-
dc.contributor.authorLee, Ho-Jin-
dc.contributor.authorMunasinghe, Wijith P-
dc.contributor.authorRoberts-Rapp, Lisa A-
dc.contributor.authorAnsell, Peter J-
dc.contributor.authorHolen, Kyle D-
dc.contributor.authorKumthekar, Priya-
dc.identifier.citationNeuro-oncology 2018; 20(6): 838-847-
dc.description.abstractWe recently reported an acceptable safety and pharmacokinetic profile of depatuxizumab mafodotin (depatux-m), formerly called ABT-414, plus radiation and temozolomide in newly diagnosed glioblastoma (arm A). The purpose of this study was to evaluate the safety and pharmacokinetics of depatux-m, either in combination with temozolomide in newly diagnosed or recurrent glioblastoma (arm B) or as monotherapy in recurrent glioblastoma (arm C). In this multicenter phase I dose escalation study, patients received depatux-m (0.5-1.5 mg/kg in arm B, 1.25 mg/kg in arm C) every 2 weeks by intravenous infusion. Maximum tolerated dose (MTD), recommended phase II dose (RP2D), and preliminary efficacy were also determined. Thirty-eight patients were enrolled as of March 1, 2016. The most frequent toxicities were ocular, occurring in 35/38 (92%) patients. Keratitis was the most common grade 3 adverse event observed in 6/38 (16%) patients; thrombocytopenia was the most common grade 4 event seen in 5/38 (13%) patients. The MTD was set at 1.5 mg/kg in arm B and was not reached in arm C. RP2D was declared as 1.25 mg/kg for both arms. Depatux-m demonstrated a linear pharmacokinetic profile. In recurrent glioblastoma patients, the progression-free survival (PFS) rate at 6 months was 30.8% and the median overall survival was 10.7 months. Best Response Assessment in Neuro-Oncology responses were 1 complete and 2 partial responses. Depatux-m alone or in combination with temozolomide demonstrated an acceptable safety and pharmacokinetic profile in glioblastoma. Further studies are currently under way to evaluate its efficacy in newly diagnosed (NCT02573324) and recurrent glioblastoma (NCT02343406).-
dc.titleSafety, pharmacokinetics, and antitumor response of depatuxizumab mafodotin as monotherapy or in combination with temozolomide in patients with glioblastoma.-
dc.typeJournal Article-
dc.identifier.affiliationDepartment of Medicine, University of Melbourne, Melbourne, Victoria, Australiaen
dc.identifier.affiliationCenter for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USAen
dc.identifier.affiliationDepartment of Medical Oncology, Austin Health, Heidelberg, Victoria, Australiaen
dc.identifier.affiliationOlivia Newton-John Cancer Research Institute, Heidelberg, Victoria, Australiaen
dc.identifier.affiliationSchool of Cancer Medicine, La Trobe University School of Cancer Medicine, Melbourne, Victoria, Australiaen
dc.identifier.affiliationDepartment of Neurology & Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, New York, USA-
dc.identifier.affiliationDepartment of Neurology, NorthShore University HealthSystem, Evanston, Illinois, USA-
dc.identifier.affiliationNeuro-Oncology Unit, Erasmus MC Cancer Center, Rotterdam, the Netherlands-
dc.identifier.affiliationDepartment of Neurological Surgery, University of California, San Francisco, California, USA-
dc.identifier.affiliationDepartment of Medical Oncology, University of Queensland School of Medicine, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia-
dc.identifier.affiliationMedical Oncology, Royal North Shore Hospital, Sydney, New South Wales, Australia-
dc.identifier.affiliationSouth Texas Accelerated Research Therapeutics, San Antonio, Texas, USA-
dc.identifier.affiliationAbbVie Inc., North Chicago, Illinois, USA-
dc.identifier.affiliationDepartment of Neurology, Northwestern University, Chicago, Illinois, USA-
dc.type.austinJournal Article-, Hui K
item.openairetypeJournal Article-
item.fulltextNo Fulltext- Oncology- Newton-John Cancer Wellness and Research Centre- Imaging and Therapy- Newton-John Cancer Research Institute-
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