2020
Phase Ib/II open-label, randomized evaluation of 2L atezolizumab (atezo) + BL-8040 versus control in MORPHEUS-pancreatic ductal adenocarcinoma (M-PDAC) and MORPHEUS-gastric cancer (M-GC).
Oh D, Ajani J, Bang Y, Chung H, Lacy J, Lee J, Macarulla T, Manji G, O'Reilly E, Allen S, Al-Sakaff N, Barak H, Patel J, Pintoffl J, Shemesh C, Zhang W, Zhang X, Chau I. Phase Ib/II open-label, randomized evaluation of 2L atezolizumab (atezo) + BL-8040 versus control in MORPHEUS-pancreatic ductal adenocarcinoma (M-PDAC) and MORPHEUS-gastric cancer (M-GC). Journal Of Clinical Oncology 2020, 38: 712-712. DOI: 10.1200/jco.2020.38.4_suppl.712.Peer-Reviewed Original ResearchControl armPhase Ib/IIEarly efficacy signalsInjection-related reactionsImmune-mediated effectsSeparate randomized trialsHigh-affinity antagonistEvaluable ptsMetastatic PDACPrimary endpointRECIST 1.1II trialEfficacy signalsRandomized trialsSafety profileAtezoDuctal adenocarcinomaPK dataRandomized EvaluationCancerGr 3PDACTrialsWkEfficacy
2014
Interim analysis of a phase II study of dose-modified FOLFIRINOX (mFOLFIRINOX) in locally advanced (LAPC) and metastatic pancreatic cancer (MPC).
James E, Yao X, Cong X, Stein S, Kaley K, Hahn C, Cha C, Salem R, Hochster H, Lacy J. Interim analysis of a phase II study of dose-modified FOLFIRINOX (mFOLFIRINOX) in locally advanced (LAPC) and metastatic pancreatic cancer (MPC). Journal Of Clinical Oncology 2014, 32: 256-256. DOI: 10.1200/jco.2014.32.3_suppl.256.Peer-Reviewed Original ResearchMetastatic pancreatic cancerAdvanced pancreatic cancerPancreatic cancerFebrile neutropeniaResponse rateEvaluable ptsProphylactic pegfilgrastimInterim analysisPhase II open-label studyGrade 3/4 toxicitiesOpen-label studyPhase II studyFDG-PET scansSimilar response ratesECOG PSNeoadjuvant FOLFIRINOXUnderwent resectionII studySurgical resectionUnacceptable toxicityPET responseFOLFIRINOXRetrospective analysisDose reductionLabel study
2012
Single-institution experience with FOLFIRINOX in advanced pancreatic cancer (PC).
Gunturu K, Thumar J, Hochster H, Stein S, Yao X, Cong X, Hahn C, Kaley K, Lacy J. Single-institution experience with FOLFIRINOX in advanced pancreatic cancer (PC). Journal Of Clinical Oncology 2012, 30: 330-330. DOI: 10.1200/jco.2012.30.4_suppl.330.Peer-Reviewed Original ResearchAdvanced pancreatic cancerPancreatic cancerProphylactic pegfilgrastimMetastatic PCFull dosesAdvanced unresectable pancreatic cancerECOG PS 0Efficacy of FOLFIRINOXRelative dose intensityUnresectable pancreatic cancerYale Cancer CenterMetastatic pancreatic cancerSingle institution experienceWarrants further evaluationCycle 1Age 60 yrEquivalent response ratesDose attenuationChemotherapy 5Evaluable ptsFebrile neutropeniaUnderwent resectionDose intensitySurgical resectionUnacceptable toxicity