2010
Phase I Dose-Escalation Study of Recombinant Human Apo2L/TRAIL, a Dual Proapoptotic Receptor Agonist, in Patients With Advanced Cancer
Herbst RS, Eckhardt SG, Kurzrock R, Ebbinghaus S, O'Dwyer PJ, Gordon MS, Novotny W, Goldwasser MA, Tohnya TM, Lum BL, Ashkenazi A, Jubb AM, Mendelson DS. Phase I Dose-Escalation Study of Recombinant Human Apo2L/TRAIL, a Dual Proapoptotic Receptor Agonist, in Patients With Advanced Cancer. Journal Of Clinical Oncology 2010, 28: 2839-2846. PMID: 20458040, DOI: 10.1200/jco.2009.25.1991.Peer-Reviewed Original ResearchConceptsRecombinant human Apo2L/TRAILRhApo2L/TRAILDose-escalation studyAdverse eventsAdvanced cancerLiver metastasesDose escalationLiver functionApo2L/TRAILI dose-escalation studyDurable partial responseRapid tumor necrosisAntitumor activityCommon adverse eventsLiver enzyme elevationMetastatic liver diseaseSerious adverse eventsAbnormal liver functionNormal liver functionMultiple intravenous dosesNecrosis factor-related apoptosis-inducing ligandPreclinical antitumor efficacyTumor necrosis factor-related apoptosis-inducing ligandFactor-related apoptosis-inducing ligandHuman clinical trials
2007
Application of pharmacodynamic assays in a phase Ia trial of Apo2L/TRAIL in patients with advanced tumors
Pan Y, Xu R, Peach M, Huang C, Branstetter D, Durbin B, Herbst R, Eckhardt G, Mendelson D, Holland P. Application of pharmacodynamic assays in a phase Ia trial of Apo2L/TRAIL in patients with advanced tumors. Journal Of Clinical Oncology 2007, 25: 3535-3535. DOI: 10.1200/jco.2007.25.18_suppl.3535.Peer-Reviewed Original ResearchGenomic DNAApo2L/TRAILRhApo2L/TRAILCaspase-3/7Advanced tumorsApoptotic markersPharmacodynamic assayEffector caspase 3/7TRAIL activityCaspase 3/7 levelsDeath inducingRecombinant human Apo2L/TRAILLigand bindingActive caspase-3Phase Ia studyReal-time PCRCellular apoptosisReceptors DR4Caspase-3Patient serum samplesTaqMan real-time PCRColo205 tumorsSerum 8M30 ELISASarcoma patients