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
2010
A first-in-human phase I study to evaluate the pan-PI3K inhibitor GDC-0941 administered QD or BID in patients with advanced solid tumors.
Von Hoff D, LoRusso P, Tibes R, Shapiro G, Weiss G, Ware J, Fredrickson J, Mazina K, Levy G, Wagner A. A first-in-human phase I study to evaluate the pan-PI3K inhibitor GDC-0941 administered QD or BID in patients with advanced solid tumors. Journal Of Clinical Oncology 2010, 28: 2541-2541. DOI: 10.1200/jco.2010.28.15_suppl.2541.Peer-Reviewed Original ResearchPan-PI3K inhibitor GDCAdvanced solid tumorsHuman phase ISolid tumorsPhase IInhibitor GDCPatientsTumors
2009
1205 A first-in-human Phase I study to evaluate the pan-PI3K inhibitor GDC-0941 administered QD or BID in patients with advanced solid tumours
Von Hoff D, Wagner A, LoRusso P, Tibes R, Jin J, Ware J, Yan Y, Derynck M, Dolezal M, Demetri G. 1205 A first-in-human Phase I study to evaluate the pan-PI3K inhibitor GDC-0941 administered QD or BID in patients with advanced solid tumours. European Journal Of Cancer Supplements 2009, 7: 122. DOI: 10.1016/s1359-6349(09)70417-3.Peer-Reviewed Original ResearchPan-PI3K inhibitor GDCAdvanced solid tumorsHuman phase ISolid tumorsPhase IInhibitor GDCPatientsTumorsA first-in-human phase I study to evaluate the pan-PI3K inhibitor GDC-0941 administered QD or BID in patients with advanced solid tumors
Wagner A, Von Hoff D, LoRusso P, Tibes R, Mazina K, Ware J, Yan Y, Derynck M, Demetri G. A first-in-human phase I study to evaluate the pan-PI3K inhibitor GDC-0941 administered QD or BID in patients with advanced solid tumors. Journal Of Clinical Oncology 2009, 27: 3501-3501. DOI: 10.1200/jco.2009.27.15_suppl.3501.Peer-Reviewed Original ResearchDose-proportional increaseAnti-tumor activityDose levelsPK dataPan-PI3K inhibitor GDCSolid tumorsPhase ICA-125 responseDose escalation armDose-escalation cohortsDrug-related AEsGrade 1/2 nauseaPreliminary PK dataSingle-dose PKAdvanced solid tumorsTotal daily dosesFDG-PET uptakeSelective oral inhibitorSteady-state PKHuman phase IProstate cancer modelPotential signsBID armCancer ptsQD arm
2008
223 POSTER Pharmacokinetics and pharmacodynamic biomarkers for the pan-PI3K inhibitor GDC-0941: Initial Phase I evaluation
LoRusso P, Sarker D, Von Hoff D, Tibes R, Derynck M, Ware J, Yan Y, Demetri G, de Bono J, Wagner A. 223 POSTER Pharmacokinetics and pharmacodynamic biomarkers for the pan-PI3K inhibitor GDC-0941: Initial Phase I evaluation. European Journal Of Cancer Supplements 2008, 6: 70-71. DOI: 10.1016/s1359-6349(08)72155-4.Peer-Reviewed Original ResearchPan-PI3K inhibitor GDCInitial phase IPharmacodynamic biomarkersPhase IInhibitor GDCPharmacokineticsBiomarkers