2017
SWOG S1310: Randomized phase II trial of single agent MEK inhibitor trametinib vs. 5-fluorouracil or capecitabine in refractory advanced biliary cancer.
Kim R, McDonough S, El-Khoueiry A, Bekaii-Saab T, Stein S, Sahai V, Keogh G, Kim E, Baron A, Siegel A, Barzi A, Guthrie K, Javle M, Hochster H. SWOG S1310: Randomized phase II trial of single agent MEK inhibitor trametinib vs. 5-fluorouracil or capecitabine in refractory advanced biliary cancer. Journal Of Clinical Oncology 2017, 35: 4016-4016. DOI: 10.1200/jco.2017.35.15_suppl.4016.Peer-Reviewed Original ResearchProgression-free survivalGrade 3 toxicityMedian overall survivalOverall survivalArm BResponse rateArm ATreatment-related grade 3 toxicitiesMedian progression-free survivalAdvanced biliary cancerGemcitabine/platinumSecond-line treatmentPhase II trialHigh-grade toxicityStandard treatment optionMEK inhibitor trametinibOverall response rateInterim futility analysisEarly promising resultsLack of responseEligible patientsInfusional 5FUStable diseaseII trialPrimary endpoint
2013
Phase II study of mFOLFOX with bevacizumab (Bev) in metastatic gastroesophageal and gastric (GE) adenocarcinoma (AC).
Li J, Kortmansky J, Fischbach N, Stein S, Yao X, Hochster H, Lacy J. Phase II study of mFOLFOX with bevacizumab (Bev) in metastatic gastroesophageal and gastric (GE) adenocarcinoma (AC). Journal Of Clinical Oncology 2013, 31: 4084-4084. DOI: 10.1200/jco.2013.31.15_suppl.4084.Peer-Reviewed Original ResearchCisplatin-based regimensOverall survivalGE adenocarcinomaResponse rateMetastatic sitesProspective phase II trialECOG PS 0/1Grade 3/4 toxicitiesMedian overall survivalPhase II studyPhase II trialPhase III studyDVT/PELiver 19Median TTPPrior gastrectomyPS 0/1GI perforationHemorrhagic eventsII studyII trialIII studyMedian survivalMedian ageGastric adenocarcinoma
2011
P1-17-07: Phase II Trial of RAD001 Plus Carboplatin in Patients with Triple-Negative Metastatic Breast Cancer.
Singh J, Stein S, Volm M, Smith J, Novik Y, Speyer J, Adams S, Meyers M, Muggia F, Schneider R, Formenti S, Omene C, Choi H, Davis S, Goldberg J, Tiersten A. P1-17-07: Phase II Trial of RAD001 Plus Carboplatin in Patients with Triple-Negative Metastatic Breast Cancer. Cancer Research 2011, 71: p1-17-07-p1-17-07. DOI: 10.1158/0008-5472.sabcs11-p1-17-07.Peer-Reviewed Original ResearchTriple-negative metastatic breast cancerGrade 3 neutropeniaMetastatic breast cancerBreast cancerClinical benefitGrade 3Platinum agentsNon-hematological grade 3Negative metastatic breast cancerTriple-negative breast cancerGrade 3 thrombocytopeniaPrior chemotherapy regimensSingle-agent carboplatinDose of carboplatinPhase II trialProgression-free survivalOral mTOR inhibitorTriple-negative breast cancer cellsDifferent breast cancer cell linesPhosphorylation site-specific antibodiesNegative breast cancer cellsBreast cancer cell linesBreast cancer cellsAkt-mTOR pathwayAssessable patients