Journal article
Efficacy and safety results of ABT-414 in combination with radiation and temozolomide in newly diagnosed glioblastoma
DA Reardon, AB Lassman, M Van Den Bent, P Kumthekar, R Merrell, AM Scott, L Fichtel, EP Sulman, E Gomez, J Fischer, HJ Lee, W Munasinghe, H Xiong, H Mandich, L Roberts-Rapp, P Ansell, KD Holen, HK Gan
Neuro Oncology | OXFORD UNIV PRESS INC | Published : 2017
Abstract
Background. The purpose of this study was to determine the maximum tolerated dose (MTD), recommended phase II dose (RPTD), safety, and pharmacokinetics of ABT-414 plus radiation and temozolomide in newly diagnosed glioblastoma. ABT-414 is a first-in-class, tumor-specific antibody-drug conjugate that preferentially targets tumors expressing overactive epidermal growth factor receptor (EGFR). Methods. In this multicenter phase I study, patients received 0.5-3.2 mg/kg ABT-414 every 2 weeks by intravenous infusion. EGFR alterations, O 6 -methylguanine-DNA methyltransferase (MGMT) promoter hypermethylation, and isocitrate dehydrogenase (IDH1) gene mutations were assessed in patient tumors. Distin..
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Awarded by AbbVie
Funding Acknowledgements
AbbVie provided financial support for this study (NCT01800695) and participated in the design, study conduct, analysis, and interpretation of data as well as the writing, review, and approval of the manuscript. All authors were involved in the data gathering, analysis, review, and interpretation.