2021
A phase I dose-escalation study of the MDM2-p53 antagonist BI 907828 in patients (pts) with advanced solid tumors.
LoRusso P, Gounder M, Patel M, Yamamoto N, Bauer T, Laurie S, Grempler R, Davenport T, Geng J, Rohrbacher M, Lahmar M. A phase I dose-escalation study of the MDM2-p53 antagonist BI 907828 in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2021, 39: 3016-3016. DOI: 10.1200/jco.2021.39.15_suppl.3016.Peer-Reviewed Original ResearchDose-limiting toxicityAdvanced solid tumorsArm AAdverse eventsArm BSolid tumorsDay 1Phase I dose-escalation studyExperienced dose-limiting toxicityNon-hematologic adverse eventsTreatment-related adverse eventsI dose-escalation studyAntitumor activityBiomarkers GDF-15Dose-escalation partGrade 3 nauseaManageable safety profileMDM2-p53 antagonistsPreliminary PK dataDose-escalation studyPatient-derived xenograftsClearance/FCycle 1Favorable PK propertiesLogistic regression models
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 treatmentHypertensionNausea
2009
Phase I Dose-Escalation and Pharmacokinetic Study of Dasatinib in Patients with Advanced Solid Tumors
Demetri G, Russo P, MacPherson I, Wang D, Morgan J, Brunton V, Paliwal P, Agrawal S, Voi M, Evans T. Phase I Dose-Escalation and Pharmacokinetic Study of Dasatinib in Patients with Advanced Solid Tumors. Clinical Cancer Research 2009, 15: 6232-6240. PMID: 19789325, DOI: 10.1158/1078-0432.ccr-09-0224.Peer-Reviewed Original ResearchConceptsDose-limiting toxicitySolid tumorsHematologic toxicityFrequent treatment-related toxicitiesDurable stable diseaseGrade 2 proteinuriaGrade 2 rashGrade 3 fatigueGrade 3 hypocalcemiaGrade 3 lethargyGrade 3 nauseaI Dose-EscalationLess hematologic toxicityGrade 3 rashObjective tumor responsePhase II doseTreatment-related toxicityAdvanced solid tumorsDose-escalation studyMetastatic solid tumorsStandard therapy existsNontreatment daysStable diseaseDaily dosingStandard therapy