2007
A phase I, first in man study of weekly IMC-A12, a fully human insulin like growth factor-I receptor IgG1 monoclonal antibody, in patients with advanced solid tumors
Higano C, Yu E, Whiting S, Gordon M, LoRusso P, Fox F, Katz T, Roecker J, Schwartz J. A phase I, first in man study of weekly IMC-A12, a fully human insulin like growth factor-I receptor IgG1 monoclonal antibody, in patients with advanced solid tumors. Journal Of Clinical Oncology 2007, 25: 3505-3505. DOI: 10.1200/jco.2007.25.18_suppl.3505.Peer-Reviewed Original ResearchIMC-A12IgG1 monoclonal antibodySolid tumorsAdvanced refractory solid tumorsHuman anti-human antibodiesMedian age 56 yearsMonoclonal antibodiesNon-compartmental PK analysisGrade 2 anemiaGrade 3 hyperglycemiaHuman IgG1 monoclonal antibodyStable radiographic diseaseTreatment related toxicityInfusion-related reactionsAdvanced solid tumorsAge 56 yearsRefractory solid tumorsHuman insulinPhase I trialWeek observation periodAnti-human antibodiesDiscolored fecesECOG PSStable diseaseStudy discontinuation
1998
Phase I clinical and pharmacological studies of benzylacyclouridine, a uridine phosphorylase inhibitor.
Pizzorno G, Yee L, Burtness BA, Marsh JC, Darnowski JW, Chu MY, Chu SH, Chu E, Leffert JJ, Handschumacher RE, Calabresi P. Phase I clinical and pharmacological studies of benzylacyclouridine, a uridine phosphorylase inhibitor. Clinical Cancer Research 1998, 4: 1165-75. PMID: 9607574.Peer-Reviewed Original ResearchConceptsPreclinical studiesDose levelsUridine concentrationPhase I clinical trialGrade 1 constipationGrade 1 elevationGrade 1 fatigueGrade 1 feverGrade 2 anemiaOral dose levelsSingle oral doseTreatment of patientsPlasma uridine concentrationBiochemical end pointsFirst-order clearanceAverage peak concentrationCancer cell linesAdvanced cancerOral dosePlasma levelsPlasma uridineClinical trialsPlasma concentrationsSustained elevationTracer dose
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