2013
Phase I study of REGN421 (R)/SAR153192, a fully-human delta-like ligand 4 (Dll4) monoclonal antibody (mAb), in patients with advanced solid tumors.
Jimeno A, LoRusso P, Strother R, Diamond J, Plato L, Younger A, Messersmith W, Kittaneh M, Sawyer D, Adriaens L, Liu L, Kao R, DiCioccio A, Brownstein C, Lowy I, Trail P, Chiorean E. Phase I study of REGN421 (R)/SAR153192, a fully-human delta-like ligand 4 (Dll4) monoclonal antibody (mAb), in patients with advanced solid tumors. Journal Of Clinical Oncology 2013, 31: 2502-2502. DOI: 10.1200/jco.2013.31.15_suppl.2502.Peer-Reviewed Original ResearchAbdominal painVentricular dysfunctionSolid tumorsGrade 3 nauseaGrade 3/4 AEsPhase II doseRight ventricular dysfunctionAcceptable safety profileAdvanced solid tumorsDose-escalation trialAnti-tumor activityBNP increaseCA125 responseHuman Dll4Prolonged SDsEscalation trialExpansion cohortPulmonary hypertensionLaboratory abnormalitiesDose escalationAdvanced cancerSafety profileFrequent treatmentHypertensionNauseaPharmacokinetics and safety of an oral ALK inhibitor, ASP3026, observed in a phase I dose escalation trial.
Patnaik A, LoRusso P, Ball H, Bahceci E, Yuen G, Papadopoulos K, Kittaneh M, Tolcher A. Pharmacokinetics and safety of an oral ALK inhibitor, ASP3026, observed in a phase I dose escalation trial. Journal Of Clinical Oncology 2013, 31: 2602-2602. DOI: 10.1200/jco.2013.31.15_suppl.2602.Peer-Reviewed Original ResearchAdvanced malignanciesDay 28Phase 1 dose-escalation trialALT/AST increasesCohort expansion phaseDose-escalating cohortsDose-escalation partECOG PS 2Grade 2 nauseaOral ALK inhibitorPre-dose valuesDose-escalation trialGrade 3 rashALK fusion geneALK receptor tyrosine kinaseAbdominal painCommon AEsEscalation trialMedian tmaxDaily dosingOral inhibitorNon-linear PKClinical activityALK inhibitorsPromising safety
2007
A phase I dose escalation trial of a daily oral CDK 4/6 inhibitor PD-0332991
O’Dwyer P, LoRusso P, DeMichele A, Gupta V, Barbi A, Dials H, Chen I, Courtney R, Wilner K, Schwartz G. A phase I dose escalation trial of a daily oral CDK 4/6 inhibitor PD-0332991. Journal Of Clinical Oncology 2007, 25: 3550-3550. DOI: 10.1200/jco.2007.25.18_suppl.3550.Peer-Reviewed Original ResearchMTD/RP2DSchedule 2/1Stable diseasePD-0332991Escalation trialPhase IPositive solid tumorsRb-positive tumorsCommon tumor typesDose-dependent increaseNovel oral inhibitorEffect of foodPhospho-Rb proteinsCommon AEsPharmacodynamic modulationMedian ageAdvanced cancerOral inhibitorPositive tumorsTumor specimensPatientsSingle agentSolid tumorsTumor typesSuccessive dose
2006
A phase I dose escalation trial of ispinesib (SB-715992) administered days 1–3 of a 21-day cycle in patients with advanced solid tumors
Heath E, Alousi A, Eder J, Valdivieso M, Vasist L, Appleman L, Bhargava P, Colevas A, Lorusso P, Shapiro G. A phase I dose escalation trial of ispinesib (SB-715992) administered days 1–3 of a 21-day cycle in patients with advanced solid tumors. Journal Of Clinical Oncology 2006, 24: 2026-2026. DOI: 10.1200/jco.2006.24.18_suppl.2026.Peer-Reviewed Original ResearchGrade 4 neutropeniaAdvanced solid tumorsDose levelsDay 1Phosphohistone 3Solid tumorsGrade 3 febrile neutropeniaMultiple murine tumor modelsGrade 1 fatigueGrade 3 neutropeniaToxicity of myelosuppressionGrade 3/4 toxicitiesSerial tumor biopsiesRenal cell carcinomaMurine tumor modelsKinesin spindle proteinPreliminary pharmacokinetic dataSignificant antitumor activityNovel cytotoxic agentsEvaluable patientsFebrile neutropeniaMTD cohortStable diseaseEscalation trialCell carcinoma