2012
MDV3100-08: A phase I open-label, dose-escalation study evaluating the safety, tolerability, and pharmacokinetics of MDV3100 in women with incurable breast cancer.
Elias A, Richer J, LoRusso P, Peterson A, Steinberg J, Mordenti J, Lopez C, Hudis C, Traina T. MDV3100-08: A phase I open-label, dose-escalation study evaluating the safety, tolerability, and pharmacokinetics of MDV3100 in women with incurable breast cancer. Journal Of Clinical Oncology 2012, 30: tps668-tps668. DOI: 10.1200/jco.2012.30.15_suppl.tps668.Peer-Reviewed Original ResearchPhase 2 doseIncurable breast cancerBreast cancerAndrogen receptorDay 1PK samplesDay 8Dose-escalation stageOverall survival benefitDose-escalation studyPhase 1 studyAR nuclear translocationInhibition of androgenPotential therapeutic strategyPK samplingAdverse eventsDaily dosingSurvival benefitAR expressionHistologic subtypeDiscontinuation criteriaPreclinical activityProstate cancerTumor assessmentMDV3100
2010
Pharmacokinetics and Safety of Bortezomib In Patients with Advanced Malignancies and Varying Degrees of Liver Dysfunction: Results of the Phase 1 National Cancer Institute Organ Dysfunction Working Group Study NCI 6432
Venkatakrishnan K, Ramanathan R, Sarantopoulos J, Mulkerin D, Shibata S, Hamilton A, Dowlati A, Mani S, Rudek M, Ivy P, Takimoto C, Neuwirth R, Parasuraman S, LoRusso P. Pharmacokinetics and Safety of Bortezomib In Patients with Advanced Malignancies and Varying Degrees of Liver Dysfunction: Results of the Phase 1 National Cancer Institute Organ Dysfunction Working Group Study NCI 6432. Blood 2010, 116: 3975. DOI: 10.1182/blood.v116.21.3975.3975.Peer-Reviewed Original ResearchMild hepatic impairmentSevere hepatic impairmentNormal hepatic functionCancer Therapy Evaluation ProgramHepatic impairmentHepatic function× ULNAdverse eventsDay 1Advanced malignanciesDose escalationNational Cancer Institute Cancer Therapy Evaluation ProgramHI groupGeometric least square mean ratioDay 8Least square mean ratioPoor hepatic functionSevere HI groupsSubsequent dose escalationUS Prescribing InformationCommon adverse eventsECOG performance statusMost adverse eventsPhase 1 studySafety of bortezomib
2007
A phase I study of BMS-582664 (brivanib alaninate), an oral dual inhibitor of VEGFR and FGFR tyrosine kinases, in combination with full-dose cetuximab in patients (pts) with advanced gastrointestinal malignancies (AGM) who failed prior therapy
Garrett C, Siu L, Giaccone G, El-Khoueiry A, Marshall J, LoRusso P, Velasquez L, Kollia G, He P, Feltquate D. A phase I study of BMS-582664 (brivanib alaninate), an oral dual inhibitor of VEGFR and FGFR tyrosine kinases, in combination with full-dose cetuximab in patients (pts) with advanced gastrointestinal malignancies (AGM) who failed prior therapy. Journal Of Clinical Oncology 2007, 25: 14018-14018. DOI: 10.1200/jco.2007.25.18_suppl.14018.Peer-Reviewed Original ResearchAdvanced gastrointestinal malignanciesFDG-PETColorectal cancerDay 8Phase I dose-escalation studyI dose-escalation studyPre-treatment FDG-PETDual tyrosine kinase inhibitorBilateral pulmonary emboliOral dual inhibitorPO day 1Treatment-related AEsFDG-PET resultsDose-escalation studyTyrosine kinase inhibitorsReproducible imaging modalityPrior therapyExpansion cohortGastrointestinal malignanciesPulmonary emboliDose escalationIntra-subject CVOral prodrugTumor responseTarget lesions