2012
A first-in-human phase Ib study to evaluate the MEK inhibitor GDC-0973, combined with the pan-PI3K inhibitor GDC-0941, in patients with advanced solid tumors.
LoRusso P, Shapiro G, Pandya S, Kwak E, Jones C, Belvin M, Musib L, de Crespigny A, McKenzie M, Gates M, Chan I, Bendell J. A first-in-human phase Ib study to evaluate the MEK inhibitor GDC-0973, combined with the pan-PI3K inhibitor GDC-0941, in patients with advanced solid tumors. Journal Of Clinical Oncology 2012, 30: 2566-2566. DOI: 10.1200/jco.2012.30.15_suppl.2566.Peer-Reviewed Original ResearchAdvanced solid tumorsPan-PI3K inhibitor GDCPhase Ib dose-escalation studySolid tumorsDays on/7 daysPartial metabolic responsePlasma PK samplesStudy drug combinationsDose-escalation studyInhibitor GDCPhase 1 trialRAS/RAF/MEKAnti-tumor activityClass I PI3K inhibitorPharmacokinetics of GDCPI3K/AktPI3K inhibitorsEvaluable ptsStable diseaseAdverse eventsPartial responseCPK elevationDose escalationElevated CPKConcurrent administration
2008
A phase I dose-escalation study of the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of a novel PI3K inhibitor, XL765, administered orally to patients (pts) with advanced solid tumors
Papadopoulos K, Markman B, Tabernero J, Patnaik A, Heath E, DeCillis A, Laird D, Aggarwal S, Nguyen L, LoRusso P. A phase I dose-escalation study of the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of a novel PI3K inhibitor, XL765, administered orally to patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2008, 26: 3510-3510. DOI: 10.1200/jco.2008.26.15_suppl.3510.Peer-Reviewed Original Research