2013
Phase I, dose-escalation study of the investigational drug TAK-733, an oral MEK inhibitor, in patients (pts) with advanced solid tumors.
Adjei A, LoRusso P, Ribas A, Sosman J, Pavlick A, Dy G, Zhou X, Gangolli E, Walker R, Kneissl M, Faucette S, Neuwirth R, Bozon V. Phase I, dose-escalation study of the investigational drug TAK-733, an oral MEK inhibitor, in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2013, 31: 2528-2528. DOI: 10.1200/jco.2013.31.15_suppl.2528.Peer-Reviewed Original ResearchAdvanced solid tumorsDrug-related AEsSolid tumorsAcneiform dermatitisTAK-733Creatine phosphokinase increaseECOG PS 0Oral MEK inhibitorDose-escalation studyDose-proportional mannerMean accumulation ratioPeripheral blood samplesAnti-tumor activitySteady-state exposurePower model analysisStable diseasePS 0Partial responseEvaluable tumorsPeripheral bloodPustular rashBlood samplesXenograft modelHuman studiesMaximal efficacy
2012
456P Multicenter, Dose-Escalation Study of the Investigational Drug Tak-733, An Oral Mek inhibitor, in Patients (PTS) with Advanced Solid Tumors: Preliminary Phase 1 Results
Adjei A, LoRusso P, Ribas A, Sosman J, Dy G, Chmielowski B, Lipman P, Zhou X, Gangolli E, Bozón V. 456P Multicenter, Dose-Escalation Study of the Investigational Drug Tak-733, An Oral Mek inhibitor, in Patients (PTS) with Advanced Solid Tumors: Preliminary Phase 1 Results. Annals Of Oncology 2012, 23: ix158. DOI: 10.1016/s0923-7534(20)33014-3.Peer-Reviewed Original ResearchDose-limiting toxicityDrug-related AEsAdvanced solid tumorsAnti-tumor activityTAK-733Solid tumorsECOG PS 0Oral MEK inhibitorDose-escalation studyMedian age 58Non-hematologic malignanciesPeripheral blood lymphocytesCycle 1Multiple xenograft modelsEvaluable ptsStable diseasePartial responsePS 0Dose escalationEvaluable tumorsAdvisory BoardBlood lymphocytesAge 58Blood samplesXenograft model507 Phase I, Open-Label, Randomized, Crossover Study Evaluating the Effects of Linifanib on Qtc Intervals in Patients with Solid Tumors
Chiu Y, LoRusso P, Ricker J, Li X, Pradhan R, Carlson D. 507 Phase I, Open-Label, Randomized, Crossover Study Evaluating the Effects of Linifanib on Qtc Intervals in Patients with Solid Tumors. Annals Of Oncology 2012, 23: ix173. DOI: 10.1016/s0923-7534(20)33069-6.Peer-Reviewed Original ResearchAdvanced solid tumorsDay 1Solid tumorsCardiac repolarizationAdequate organ functionECOG PS 0Primary end pointExposure-response analysisEffects modelMeasurable diseaseMorning doseOpen labelCrossover fashionPS 0QTc prolongationStandard therapyCrossover studyQTc intervalBaseline QTcFQTcF intervalStudy completion
2009
Retrospective study of phase I clinical trials participation in patients at least 65 years of age at Karmanos Cancer Institute (KCI), Wayne State University, Detroit, Michigan
Vishnu P, Jasti P, Ding L, Heilbrun L, Venkatramanamoorthy R, LoRusso P, Heath E. Retrospective study of phase I clinical trials participation in patients at least 65 years of age at Karmanos Cancer Institute (KCI), Wayne State University, Detroit, Michigan. Journal Of Clinical Oncology 2009, 27: e20626-e20626. DOI: 10.1200/jco.2009.27.15_suppl.e20626.Peer-Reviewed Original ResearchKarmanos Cancer InstitutePhase 1 clinical trialOverall survivalClinical trialsPhase ICommon grade 3Median overall survivalPerformance status 1Retrospective chart reviewClinical trial participationYears of ageChart reviewElderly patientsElectrolyte abnormalitiesPatient agePatient demographicsPS 0Biologic agentsMedian ageStatus 1Lack of enrollmentRetrospective studyCombination therapyPatient subgroupsStudy criteria