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
Phase I experience with c-MET inhibitor XL880 administered orally to patients (pts) with solid tumors
Eder J, Heath E, Appleman L, Shapiro G, Wang D, Malburg L, Zhu A, Leader T, Wolanski A, LoRusso P. Phase I experience with c-MET inhibitor XL880 administered orally to patients (pts) with solid tumors. Journal Of Clinical Oncology 2007, 25: 3526-3526. DOI: 10.1200/jco.2007.25.18_suppl.3526.Peer-Reviewed Original ResearchStable diseaseTumor biopsiesPhase ITreatment tumor biopsiesCommon adverse eventsECOG performance statusPhase II trialPhase 1 studyCorrelative studiesHepatocyte growth factor receptorInhibition of PDGFRβAdequate liverEvaluable ptsGrowth factor receptorII trialRECIST criteriaAdverse eventsBrain metastasesHepatic transaminasesPartial responsePerformance statusRenal functionDaily dosePlasma markersNeck cancer