2016
Phase I study of pemetrexed with sorafenib in advanced solid tumors
Poklepovic A, Gordon S, Shafer DA, Roberts JD, Bose P, Geyer CE, McGuire WP, Tombes MB, Shrader E, Strickler K, Quigley M, Wan W, Kmieciak M, Massey HD, Booth L, Moran RG, Dent P. Phase I study of pemetrexed with sorafenib in advanced solid tumors. Oncotarget 2016, 7: 42625-42638. PMID: 27213589, PMCID: PMC5173162, DOI: 10.18632/oncotarget.9434.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCohort StudiesFemaleHumansInflammationMaleMaximum Tolerated DoseMiddle AgedNeoplasmsNiacinamidePemetrexedPhenylurea CompoundsPTEN PhosphohydrolaseSorafenibTreatment OutcomeTriple Negative Breast NeoplasmsConceptsAdvanced solid tumorsDay 1Solid tumorsOral sorafenibDose scheduleBreast cancerTriple-negative breast cancerDose-escalation schemaPhase II dosePhase I trialSorafenib dosingSorafenib therapyStable diseaseCohort BComplete responseI trialPartial responseTolerable combinationRadiographic assessmentCumulative toxicityCombination treatmentPatientsSorafenibPhase IAntitumor activity
2011
Phase II Trials Powered to Detect Tumor Subtypes
Roberts JD, Ramakrishnan V. Phase II Trials Powered to Detect Tumor Subtypes. Clinical Cancer Research 2011, 17: 5538-5545. PMID: 21737510, DOI: 10.1158/1078-0432.ccr-10-2466.Peer-Reviewed Original ResearchConceptsTumor subtypesResponse ratePhase II trial designPhase II trialPhase III trialsOverall response ratePhase II designStage 1Characterization of tumorsII trialIII trialsMetastatic diseaseSimilar patientsProspective characterizationSample sizeTrial designSubtypesTumorsTotal sample sizePhase IIII designTrialsTreatmentVariables of interestDifferent treatments