2015
Orally administered colony stimulating factor 1 receptor inhibitor PLX3397 in recurrent glioblastoma: an Ivy Foundation Early Phase Clinical Trials Consortium phase II study
Butowski N, Colman H, De Groot JF, Omuro AM, Nayak L, Wen PY, Cloughesy TF, Marimuthu A, Haidar S, Perry A, Huse J, Phillips J, West BL, Nolop KB, Hsu HH, Ligon KL, Molinaro AM, Prados M. Orally administered colony stimulating factor 1 receptor inhibitor PLX3397 in recurrent glioblastoma: an Ivy Foundation Early Phase Clinical Trials Consortium phase II study. Neuro-Oncology 2015, 18: 557-564. PMID: 26449250, PMCID: PMC4799682, DOI: 10.1093/neuonc/nov245.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAminopyridinesBiomarkers, TumorBlood-Brain BarrierBrain NeoplasmsCohort StudiesFemaleFollow-Up StudiesGlioblastomaHumansImmunoenzyme TechniquesMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPrognosisPyrrolesReceptors, Granulocyte-Macrophage Colony-Stimulating FactorTissue DistributionTumor BurdenConceptsPhase II studyII studyRecurrent glioblastomaTumor tissueMedian drug levelsPrimary efficacy endpointProgression-free survivalBlood-brain barrierPretreatment baseline valuesBlood-tumor barrierExploratory endpointsInhibitor PLX3397Efficacy endpointPrimary endpointSecondary endpointsObjective responseSurgical resectionOral dosePharmacodynamic changesPharmacodynamic measuresTumor burdenDrug exposureTissue pharmacokineticsDrug levelsStem cell factor
2008
Effect of Age of Infusion Site and Type of Rapid-Acting Analog on Pharmacodynamic Parameters of Insulin Boluses in Youth With Type 1 Diabetes Receiving Insulin Pump Therapy
Swan KL, Dziura JD, Steil GM, Voskanyan GR, Sikes KA, Steffen AT, Martin ML, Tamborlane WV, Weinzimer SA. Effect of Age of Infusion Site and Type of Rapid-Acting Analog on Pharmacodynamic Parameters of Insulin Boluses in Youth With Type 1 Diabetes Receiving Insulin Pump Therapy. Diabetes Care 2008, 32: 240-244. PMID: 19017777, PMCID: PMC2628686, DOI: 10.2337/dc08-0595.Peer-Reviewed Original ResearchConceptsInsulin pump therapyGlucose infusion rateType 1 diabetesDay 1Day 4Pump therapyInsulin aspartPharmacodynamic parametersInsulin actionInsulin bolusRapid acting analogsEuglycemic clamp procedureExogenous glucose infusionGIR curveEffect of agePharmacodynamic measuresPharmacodynamic characteristicsClamp procedureInfusion siteGlucose infusionInfusion rateInsulin analoguesType 1AspartOverall insulin action
2005
Dynamic Contrast-Enhanced Magnetic Resonance Imaging As a Pharmacodynamic Measure of Response After Acute Dosing of AG-013736, an Oral Angiogenesis Inhibitor, in Patients With Advanced Solid Tumors: Results From a Phase I Study
Liu G, Rugo HS, Wilding G, McShane TM, Evelhoch JL, Ng C, Jackson E, Kelcz F, Yeh BM, Lee FT, Charnsangavej C, Park JW, Ashton EA, Steinfeldt HM, Pithavala YK, Reich SD, Herbst RS. Dynamic Contrast-Enhanced Magnetic Resonance Imaging As a Pharmacodynamic Measure of Response After Acute Dosing of AG-013736, an Oral Angiogenesis Inhibitor, in Patients With Advanced Solid Tumors: Results From a Phase I Study. Journal Of Clinical Oncology 2005, 23: 5464-5473. PMID: 16027440, DOI: 10.1200/jco.2005.04.143.Peer-Reviewed Original ResearchConceptsAdvanced solid tumorsAG-013736Vascular responsesMagnetic resonance imagingAcute dosingDay 2Solid tumorsAngiogenesis inhibitorsResonance imagingContrast-enhanced magnetic resonance imagingOral angiogenesis inhibitorSchedule of therapyTumor vascular functionDynamic contrast-enhanced magnetic resonance imagingObjective disease responsePhase II testingDCE-MRI scansEffect of treatmentTumor vascular parametersVolume transfer constantMorning doseSuitable markerPharmacodynamic measuresVascular functionPharmacodynamic response
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