2020
Exposure‐Response and Population Pharmacokinetic Analyses of a Novel Subcutaneous Formulation of Daratumumab Administered to Multiple Myeloma Patients
Luo M, Usmani S, Mateos M, Nahi H, Chari A, San‐Miguel J, Touzeau C, Suzuki K, Kaiser M, Carson R, Heuck C, Qi M, Zhou H, Sun Y, Parasrampuria D. Exposure‐Response and Population Pharmacokinetic Analyses of a Novel Subcutaneous Formulation of Daratumumab Administered to Multiple Myeloma Patients. The Journal Of Clinical Pharmacology 2020, 61: 614-627. PMID: 33145788, PMCID: PMC8048619, DOI: 10.1002/jcph.1771.Peer-Reviewed Original ResearchConceptsSubcutaneous formulation of daratumumabIncidence of neutropeniaIntravenous daratumumabMonotherapy studiesCombination therapySubcutaneous daratumumabPK samplingStandard-of-care regimensPeak-to-trough fluctuationHigher trough concentrationsCombination therapy studiesSafety end pointMultiple myeloma patientsPopulation pharmacokinetic analysisCycle 1Flat doseExposure-response analysesMyeloma patientsDaratumumabTrough concentrationsSubcutaneous formulationPharmacokinetic analysisTreatment periodTherapy studiesNeutropenia
2019
ATIM-17. A PHASE I TRIAL OF HYPOFRACTIONATED STEREOTACTIC IRRADIATION (HFSRT) COMBINED WITH NIVOLUMAB (NIVO), IPILIMUMAB (IPI) AND BEVACIZUMAB (BEV) IN PATIENTS (PTS) WITH RECURRENT HIGH GRADE GLIOMAS
Sahebjam S, Forsyth P, Tran N, Etame A, Arrington J, Jaglal M, Mokhtari S, MacAulay R, Wicklund M, Evernden B, Gatewood T, Robinson T, Raval R, Yu M. ATIM-17. A PHASE I TRIAL OF HYPOFRACTIONATED STEREOTACTIC IRRADIATION (HFSRT) COMBINED WITH NIVOLUMAB (NIVO), IPILIMUMAB (IPI) AND BEVACIZUMAB (BEV) IN PATIENTS (PTS) WITH RECURRENT HIGH GRADE GLIOMAS. Neuro-Oncology 2019, 21: vi5-vi5. PMCID: PMC6847102, DOI: 10.1093/neuonc/noz175.017.Peer-Reviewed Original ResearchGrade 1 elevationExpansion cohortSafety cohortPD-1/PDLStrong pre-clinical evidencesAnti-tumor immune responseRecurrent high-grade gliomaPhase IDose-expansion cohortsGrade 1 anorexiaGrade 1 diarrheaRT treatment fieldUse of corticosteroidsPre-clinical evidenceHigh-grade gliomasPrimary study objectiveCommon toxicitiesEligible ptsPrior RTSecondary endpointsFlat doseRecurrent tumorsGrade IIITumor regressionEfficacy data
2018
Multicenter Phase IB Trial of Carboxyamidotriazole Orotate and Temozolomide for Recurrent and Newly Diagnosed Glioblastoma and Other Anaplastic Gliomas.
Omuro A, Beal K, McNeill K, Young RJ, Thomas A, Lin X, Terziev R, Kaley TJ, DeAngelis LM, Daras M, Gavrilovic IT, Mellinghoff I, Diamond EL, McKeown A, Manne M, Caterfino A, Patel K, Bavisotto L, Gorman G, Lamson M, Gutin P, Tabar V, Chakravarty D, Chan TA, Brennan CW, Garrett-Mayer E, Karmali RA, Pentsova E. Multicenter Phase IB Trial of Carboxyamidotriazole Orotate and Temozolomide for Recurrent and Newly Diagnosed Glioblastoma and Other Anaplastic Gliomas. Journal Of Clinical Oncology 2018, 36: 1702-1709. PMID: 29683790, PMCID: PMC5993168, DOI: 10.1200/jco.2017.76.9992.Peer-Reviewed Original ResearchConceptsAnaplastic gliomasCohort 2Cohort 1Median progression-free survivalFavorable brain penetrationMedian overall survivalPhase Ib studyPhase Ib trialPhase II doseProgression-free survivalRecurrent anaplastic gliomasDependent calcium channelsNovel oral inhibitorSignal of activityMismatch repair genesIb trialTreat populationMethylguanine-DNA methyltransferaseOverall survivalComplete responseFlat doseOral inhibitorBrain penetrationResults FortyTherapeutic concentrations
2017
First-in-human phase I study of an oral HSP90 inhibitor, TAS-116, in advanced solid tumors.
Yanagitani N, Horiike A, Kitazono S, Ohyanagi F, Kondo S, Shimomura A, Fujiwara Y, Doi T, Kuboki Y, Kawazoe A, Shitara K, Ohno I, Banerji U, Sundar R, Ohkubo S, Huang J, Nishio M, Yamamoto N. First-in-human phase I study of an oral HSP90 inhibitor, TAS-116, in advanced solid tumors. Journal Of Clinical Oncology 2017, 35: 2546-2546. DOI: 10.1200/jco.2017.35.15_suppl.2546.Peer-Reviewed Original ResearchTAS-116Solid tumorsFirst-in-human phase I studyAntitumor activityOral Hsp90 inhibitorAccelerated titration designPhase 2 studyPhase I studyPreliminary antitumor activityPhase 1 studyEvidence of target engagementDose expansionFlat doseEscalating dosesDose proportionalityRepeated administrationQD scheduleSafety profileEye disordersIncreased creatinineAdverse eventsTitration designDays administrationNon-purinePatients
2007
A phase I study of EC145 administered weeks 1 and 3 of a 4-week cycle in patients with refractory solid tumors
Sausville E, LoRusso P, Quinn M, Forman K, Leamon C, Morganstern D, Bever S, Messmann R. A phase I study of EC145 administered weeks 1 and 3 of a 4-week cycle in patients with refractory solid tumors. Journal Of Clinical Oncology 2007, 25: 2577-2577. DOI: 10.1200/jco.2007.25.18_suppl.2577.Peer-Reviewed Original ResearchBolus dosesDay 1Folate receptorPhase IRefractory solid tumorsCommon side effectsFolic acidPhase I trialTime of presentationIntravenous bolus doseEligible patientsDisease stabilizationFlat doseI trialIntravenous bolusBolus doseMinor responsePK analysisSide effectsPatientsWeek 1Dose levelsEscalation plansSolid tumorsPK model
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