2013
Predictive value of phase I trials for safety and final approved dose in later trials: Analysis of 33,845 patients.
Fontes Jardim D, Hess K, LoRusso P, Kurzrock R, Hong D. Predictive value of phase I trials for safety and final approved dose in later trials: Analysis of 33,845 patients. Journal Of Clinical Oncology 2013, 31: 2509-2509. DOI: 10.1200/jco.2013.31.15_suppl.2509.Peer-Reviewed Original ResearchDose-limiting toxicityMultiple logistic regression analysisDeath rateLater trialsPhase IPhase II doseRelevant side effectsDose of agentDrug Administration websiteLogistic regression analysisChi-squared testAdverse eventsMultivariable analysisSafety profileFinal doseGrade 3Oral drugsNew agentsSide effectsPackage insertsPredictive valueUS FoodRegistration trialsCytotoxic agentsSignificant toxicity
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