2014
882PD Phase 1/2 Study of Oral Rucaparib: Updated Phase 1 and Preliminary Phase 2 Results
Kristeleit R, Shapira-Frommer R, Burris H, Patel M, Lorusso P, Oza A, Balmaña J, Domchek S, Chen L, Montes A, Plummer R, Arkenau H, Maloney L, Dominy E, Shapiro G. 882PD Phase 1/2 Study of Oral Rucaparib: Updated Phase 1 and Preliminary Phase 2 Results. Annals Of Oncology 2014, 25: iv307. DOI: 10.1093/annonc/mdu338.8.Peer-Reviewed Original ResearchAdvanced solid tumorsDurable benefitSolid tumorsDana-Farber Cancer InstituteHighest LOHCA-125 responsePhase 1/2 studyDose-escalation designPhase 1Homologous recombination-deficient tumorsOral PARP inhibitorClinical trial fundingPhase 2CA125 responseCommon AEsOral rucaparibRelapsed diseaseLow HgbEscalation designLow plateletsClinical benefitLab abnormalitiesBRCA mutationsPancreatic cancerClinical trials
2009
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
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