2011
Evaluation of pharmacodynamic biomarkers in a Phase 1a trial of dulanermin (rhApo2L/TRAIL) in patients with advanced tumours
Pan Y, Xu R, Peach M, Huang CP, Branstetter D, Novotny W, Herbst RS, Eckhardt SG, Holland PM. Evaluation of pharmacodynamic biomarkers in a Phase 1a trial of dulanermin (rhApo2L/TRAIL) in patients with advanced tumours. British Journal Of Cancer 2011, 105: 1830-1838. PMID: 22033270, PMCID: PMC3251880, DOI: 10.1038/bjc.2011.456.Peer-Reviewed Original ResearchConceptsCell death markersAdvanced tumorsPharmacodynamic biomarkersApoptotic markersPhase 1a studyPhase 1a trialDeath receptors DR4Colo205 tumorsSerum 8Patients 24Active caspase-3Patient seraColo205 xenograftsEvidence of activitySubsequent cell deathCytokeratin 18PatientsTransient increaseDulanerminReceptors DR4TumorsCaspase-3SerumCaspase-3/7Significant increase
2006
Apo2L/TRAIL pharmacokinetics in a phase 1a trial in advanced cancer and lymphoma
Ling J, Herbst R, Mendelson D, Eckhardt S, O’Dwyer P, Ebbinghaus S, Osborne R, Cheu M, Lieberman G, Lum B. Apo2L/TRAIL pharmacokinetics in a phase 1a trial in advanced cancer and lymphoma. Journal Of Clinical Oncology 2006, 24: 3047-3047. DOI: 10.1200/jco.2006.24.18_suppl.3047.Peer-Reviewed Original ResearchApo2L/TRAILCohort 1PK dataSerum concentrationsCohort 2Preclinical modelsRecombinant human Apo2L/TRAILPhase 1a studyPhase 1a trialMild liver dysfunctionNon-compartmental analysisTumor xenograft modelSensitive ELISA assayLiver dysfunctionLiver metastasesPK assessmentAdvanced cancerHepatic metastasesIV infusionNonclinical modelsHematologic cancersXenograft modelClinical developmentDay 1Dose levels