2015
A phase I study of investigational agent SGI-110 combined with irinotecan in previously treated metastatic colorectal cancer patients.
Wang J, Gootjes E, Uram J, Zahurak M, El-Khoueiry A, Verheul H, Ahuja N, Azad N. A phase I study of investigational agent SGI-110 combined with irinotecan in previously treated metastatic colorectal cancer patients. Journal Of Clinical Oncology 2015, 33: tps797-tps797. DOI: 10.1200/jco.2015.33.3_suppl.tps797.Peer-Reviewed Original ResearchDose level 1SGI-110Colorectal cancerPhase ITumor biopsiesDay 1Metastatic colorectal cancer patientsRandomized phase II studyMajor eligibility criteriaPeriodic CT scansPhase II studyGrowth factor supportColorectal cancer patientsM2 days 1Metastatic colon adenocarcinomaMetastatic colon cancerCRC cell linesAdditional dose levelsEvaluation of biomarkersMeasureable diseaseTotal therapyII studyIrinotecan therapyDose escalationFactor support
2006
Phase I study to determine the safety of oral administration of TAS-102 on a twice daily (BID) schedule for five days a week (wk) followed by two days rest for two wks, every (Q) four wks in patients (pts) with metastatic breast cancer (MBC)
Green M, Pusztai L, Theriault R, Adinin R, Hofweber M, Fukushima M, Mita A, Bindra N, Hortobagyi G. Phase I study to determine the safety of oral administration of TAS-102 on a twice daily (BID) schedule for five days a week (wk) followed by two days rest for two wks, every (Q) four wks in patients (pts) with metastatic breast cancer (MBC). Journal Of Clinical Oncology 2006, 24: 10576-10576. DOI: 10.1200/jco.2006.24.18_suppl.10576.Peer-Reviewed Original ResearchMetastatic breast cancerPhase II doseBID days 1TAS-102Dose levelsBreast cancerDay 1Grade 3 non-hematologic toxicityEvaluable metastatic breast cancerInitial starting doseNon-hematologic toxicitiesInitial dose levelAdditional dose levelsHighest dose levelEvaluation of responseMinimal alopeciaHematologic toxicityStarting doseDaily dosingStandard therapyOral combinationStudy doseClinical activityOral administrationGrade 3
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