2012
Clinical pharmacokinetics of the Smac-mimetic birinapant (TL32711) as a single agent and in combination with multiple chemotherapy regimens.
Fetterly G, Liu B, Senzer N, Amaravadi R, Schilder R, Martin L, LoRusso P, Papadopoulos K, Adjei A, Zagst P, McKinlay M, Weng D, Graham M. Clinical pharmacokinetics of the Smac-mimetic birinapant (TL32711) as a single agent and in combination with multiple chemotherapy regimens. Journal Of Clinical Oncology 2012, 30: 3029-3029. DOI: 10.1200/jco.2012.30.15_suppl.3029.Peer-Reviewed Original ResearchPaclitaxel/carboplatinMultiple chemotherapy regimensChemotherapy regimensWeekly dosingInterpatient variabilityLiposomal doxorubicinPK modelDose-proportional kineticsModerate interpatient variabilityPopulation PK modelPopulation PK modelingSMAC mimetic birinapantBlockade of apoptosisAdvanced malignanciesCombination regimensConcomitant administration
2009
Population Pharmacokinetics of Trastuzumab-DM1, a First-in-Class HER2 Antibody-Drug Conjugate Given Every 3 Weeks (q3w) and Weekly (qw) to Patients with HER2-Positive Metastatic Breast Cancer (MBC).
LoRusso P, Girish S, Burris H, Beeram M, Vukelja S, Modi S, Yi J, Wang B, Saad O, Gupta M. Population Pharmacokinetics of Trastuzumab-DM1, a First-in-Class HER2 Antibody-Drug Conjugate Given Every 3 Weeks (q3w) and Weekly (qw) to Patients with HER2-Positive Metastatic Breast Cancer (MBC). Cancer Research 2009, 69: 5099-5099. DOI: 10.1158/0008-5472.sabcs-09-5099.Peer-Reviewed Original ResearchMetastatic breast cancerHER2-positive metastatic breast cancerHER2 antibody-drug conjugatesPhase II trialT-DM1Antibody-drug conjugatesII trialClinical factorsInter-individual variabilityTumor burdenIndividual patientsCovariate analysisPK parametersPK dataPK modelOngoing phase II trialSubsequent phase II trialTwo-compartment linear modelPhase I trialPopulation PK modelPopulation pharmacokinetic modelMultiple dose levelsConcentration-time dataAvailable PK dataPK parameter values
2007
A phase I study of EC145 administered weeks 1 and 3 of a 4-week cycle in patients with refractory solid tumors
Sausville E, LoRusso P, Quinn M, Forman K, Leamon C, Morganstern D, Bever S, Messmann R. A phase I study of EC145 administered weeks 1 and 3 of a 4-week cycle in patients with refractory solid tumors. Journal Of Clinical Oncology 2007, 25: 2577-2577. DOI: 10.1200/jco.2007.25.18_suppl.2577.Peer-Reviewed Original ResearchBolus dosesDay 1Folate receptorPhase IRefractory solid tumorsCommon side effectsFolic acidPhase I trialTime of presentationIntravenous bolus doseEligible patientsDisease stabilizationFlat doseI trialIntravenous bolusBolus doseMinor responsePK analysisSide effectsPatientsWeek 1Dose levelsEscalation plansSolid tumorsPK model