2022
Hybrid-control arm construction using historical trial data for an early-phase, randomized controlled trial in metastatic colorectal cancer
Li C, Ferro A, Mhatre SK, Lu D, Lawrance M, Li X, Li S, Allen S, Desai J, Fakih M, Cecchini M, Pedersen KS, Kim TY, Reyes-Rivera I, Segal NH, Lenain C. Hybrid-control arm construction using historical trial data for an early-phase, randomized controlled trial in metastatic colorectal cancer. Communications Medicine 2022, 2: 90. PMID: 35856081, PMCID: PMC9287310, DOI: 10.1038/s43856-022-00155-y.Peer-Reviewed Original ResearchMetastatic colorectal cancerExperimental armColorectal cancerMetastatic colorectal cancer (mCRC) trialsMetastatic colorectal cancer patientsPhase Ib/IITrial dataHistorical trial dataColorectal cancer trialsDisease control rateObjective response ratePhase 3 trialProgression-free survivalColorectal cancer patientsStandardized mortality ratioEarly phase trialsEarly phase clinical developmentLogistic regression modelsMultiple experimental armsPrimary endpointOverall survivalPrior linesEfficacy signalsSafety profileCombination therapy
2019
A phase I study of TAS-102 in combination with oxaliplatin (TAS-OX) for refractory metastatic colorectal cancer (mCRC).
Cecchini M, Kortmansky J, Lacy J, Fischbach N, Thumar J, Sabbath K, Gomez C, Sporn J, Stein S, Hochster H. A phase I study of TAS-102 in combination with oxaliplatin (TAS-OX) for refractory metastatic colorectal cancer (mCRC). Journal Of Clinical Oncology 2019, 37: 630-630. DOI: 10.1200/jco.2019.37.4_suppl.630.Peer-Reviewed Original ResearchDisease control rateMetastatic colorectal cancerTAS-102Progressive diseaseDay 1Thymidine phosphorylase inhibitorRefractory metastatic colorectal cancerDose-escalating studyECOG PS 0Phase II doseEfficacy of oxaliplatinUsual laboratory parametersEligible patientsEvaluable patientsMeasurable diseaseUnexpected AEsStarting doseTreatment discontinuationPS 0Improved survivalLaboratory parametersOral combinationColorectal cancerPatient populationControl rate