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
2012
Phase I study of humanized monoclonal antibody AVE1642 directed against the type 1 insulin-like growth factor receptor (IGF-1R), administered in combination with anticancer therapies to patients with advanced solid tumors
Macaulay V, Middleton M, Protheroe A, Tolcher A, Dieras V, Sessa C, Bahleda R, Blay J, LoRusso P, Mery-Mignard D, Soria J. Phase I study of humanized monoclonal antibody AVE1642 directed against the type 1 insulin-like growth factor receptor (IGF-1R), administered in combination with anticancer therapies to patients with advanced solid tumors. Annals Of Oncology 2012, 24: 784-791. PMID: 23104723, PMCID: PMC3574548, DOI: 10.1093/annonc/mds511.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsDeoxycytidineDiarrheaDocetaxelDoxorubicinErlotinib HydrochlorideFemaleGemcitabineHumansLeiomyosarcomaMaleMelanomaMiddle AgedQuinazolinesReceptor, IGF Type 1Skin NeoplasmsSoft Tissue NeoplasmsTaxoidsTreatment OutcomeConceptsAdvanced solid tumorsInsulin-like growth factor receptorType 1 insulin-like growth factor receptorGrowth factor receptorIGF-IISolid tumorsDisease controlCommon adverse eventsFactor receptorIGF-1R antibodyDurable disease controlCohort C2Adverse eventsPartial responseCohort BDocetaxel administrationSteroid premedicationControl ratePK interactionsGrade 3IGF-BP3Blood samplesCohort C1PatientsAVE1642
2009
Phase I study combining an IGFR inhibitor (IMC-A12) and an mTOR inhibitor (temsirolimus) in patients with solid tumors or lymphoma
Naing A, LoRusso P, Mills G, Berry D, Doyle L, Rohren E, Burger A, Chen H, Busaidy N, Kurzrock R. Phase I study combining an IGFR inhibitor (IMC-A12) and an mTOR inhibitor (temsirolimus) in patients with solid tumors or lymphoma. Journal Of Clinical Oncology 2009, 27: e14535-e14535. DOI: 10.1200/jco.2009.27.15_suppl.e14535.Peer-Reviewed Original ResearchIMC-A12MTOR inhibitorsDose cohortsSolid tumorsBiologic effectsType I insulin-like growth factor receptorCommon grade 1Dose-escalation cohortsImmunosuppressive agent sirolimusLambda monoclonal antibodySolid tumor histologiesGrade 2 toxicityAdvanced solid tumorsHistory of diabetesI insulin-like growth factor receptorInsulin-like growth factor receptorCombination of temsirolimusGrowth factor receptorStable diseaseEscalation cohortsWeekly doseTumor histologyGrade 3IGFR inhibitorsTherapeutic effect