2016
A Phase I Pharmacokinetic Study of Trastuzumab Emtansine (T-DM1) in Patients with Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function
Li C, Agarwal P, Gibiansky E, Jin J, Dent S, Gonçalves A, Nijem I, Strasak A, Harle-Yge M, Chernyukhin N, LoRusso P, Girish S. A Phase I Pharmacokinetic Study of Trastuzumab Emtansine (T-DM1) in Patients with Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function. Clinical Pharmacokinetics 2016, 56: 1069-1080. PMID: 27995530, DOI: 10.1007/s40262-016-0496-y.Peer-Reviewed Original ResearchConceptsNormal hepatic functionModerate hepatic impairmentHepatic impairmentMetastatic breast cancerHepatic functionTrastuzumab emtansineBreast cancerCycle 1Positive metastatic breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Phase I pharmacokinetic studyHuman epidermal growth factor receptorChild-Pugh criteriaMild hepatic impairmentT-DM1 3.6T-DM1 exposureGrowth factor receptor 2I pharmacokinetic studyFactor receptor 2Epidermal growth factor receptorGrowth factor receptorModerate cohortBaseline albuminT-DM1
2011
Phase I pharmacokinetic study of temsirolimus (CCI-779) in patients with advanced malignancies and normal and impaired liver function: An NCI Organ Dysfunction Working Group (ODWG) study.
Sarantopoulos J, Lenz H, LoRusso P, Shibata S, Kummar S, Mulkerin D, Ramanathan R, Mita M, O'Rourke P, Remick S, Goel S, Gutierrez M, Ramalingam S, Murgo A, Davies A, Mani S, Boni J, Shapiro M, Ivy S, Takimoto C. Phase I pharmacokinetic study of temsirolimus (CCI-779) in patients with advanced malignancies and normal and impaired liver function: An NCI Organ Dysfunction Working Group (ODWG) study. Journal Of Clinical Oncology 2011, 29: 3072-3072. DOI: 10.1200/jco.2011.29.15_suppl.3072.Peer-Reviewed Original Research
2010
A phase I pharmacokinetic study of pulse-dose vorinostat with flavopiridol in solid tumors
Dickson MA, Rathkopf DE, Carvajal RD, Grant S, Roberts JD, Reid JM, Ames MM, McGovern RM, Lefkowitz RA, Gonen M, Cane LM, Dials HJ, Schwartz GK. A phase I pharmacokinetic study of pulse-dose vorinostat with flavopiridol in solid tumors. Investigational New Drugs 2010, 29: 1004-1012. PMID: 20461440, PMCID: PMC3545439, DOI: 10.1007/s10637-010-9447-x.Peer-Reviewed Original ResearchConceptsSerum levelsPhase I pharmacokinetic studyIntermittent high doseResults 34 patientsD1-3I pharmacokinetic studyCyclin-dependent kinase inhibitor flavopiridolKinase inhibitor flavopiridolStable diseaseOral doseOral dosingHigh doseCombination treatmentPatientsSolid tumorsCmaxOne weekDosePharmacokinetic studyVorinostatMTDFlavopiridolNeutropeniaChemotherapyLevels
2002
Epidermal growth factor receptors as a target for cancer treatment: The emerging role of IMC-C225 in the treatment of lung and head and neck cancers
Herbst RS, Langer CJ. Epidermal growth factor receptors as a target for cancer treatment: The emerging role of IMC-C225 in the treatment of lung and head and neck cancers. Seminars In Oncology 2002, 29: 27-36. PMID: 11894011, DOI: 10.1053/sonc.2002.31525.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCetuximabCombined Modality TherapyErbB ReceptorsGene Expression Regulation, NeoplasticHalf-LifeHead and Neck NeoplasmsHumansNeoplasm MetastasisNeoplasm Recurrence, LocalRadiation-Sensitizing AgentsRandomized Controlled Trials as TopicSalvage TherapyConceptsSquamous cell carcinomaEpidermal growth factor receptorIMC-C225Phase II trialGrowth factor receptorCell carcinomaII trialFactor receptorRadiation therapyNon-small cell lung cancer xenograftsNon-small cell lung cancerGemcitabine/carboplatin combinationSeparate phase II trialsAdvanced squamous cell carcinomaCell lung cancer xenograftsOngoing phase II trialEastern Cooperative Oncology GroupPhase III registration trialPhase I pharmacokinetic studyCultured human squamous cell carcinomasHuman squamous cell carcinomaPaclitaxel/carboplatinSecond-line settingStandard salvage regimensTreatment-naive patients
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