2014
AT-23A PHASE II STUDY OF LAPATINIB AND DOSE-DENSE TEMOZOLOMIDE (TMZ) FOR ADULTS WITH RECURRENT EPENDYMOMA: A CERN CLINICAL TRIAL
Gilbert M, Yuan Y, Wani K, Wu J, Omuro A, Lieberman F, Robins H, Gerstner E, Wu J, Wen P, Mikkelsen T, Armstrong T, Aldape K. AT-23A PHASE II STUDY OF LAPATINIB AND DOSE-DENSE TEMOZOLOMIDE (TMZ) FOR ADULTS WITH RECURRENT EPENDYMOMA: A CERN CLINICAL TRIAL. Neuro-Oncology 2014, 16: v13-v13. PMCID: PMC4217801, DOI: 10.1093/neuonc/nou237.23.Peer-Reviewed Original ResearchDose-dense temozolomideClinical trialsPredictive markerFirst prospective clinical trialPhase II studyPrimary CNS tumorsProspective clinical trialsPossible predictive markerPotential predictive markerPatient reported outcomesSubsequent clinical trialsMGMT promoter statusMedian KPSMedian progressionPrimary endpointRecurrent diseaseII studyOverall survivalSymptom burdenMedian ageInitial treatmentCNS tumorsExtensive resectionStandard treatmentPRO collectionClinical course and progression-free survival of adult intracranial and spinal ependymoma patients
Vera-Bolanos E, Aldape K, Yuan Y, Wu J, Wani K, Necesito-Reyes MJ, Colman H, Dhall G, Lieberman FS, Metellus P, Mikkelsen T, Omuro A, Partap S, Prados M, Robins HI, Soffietti R, Wu J, Gilbert MR, Armstrong TS. Clinical course and progression-free survival of adult intracranial and spinal ependymoma patients. Neuro-Oncology 2014, 17: 440-447. PMID: 25121770, PMCID: PMC4483095, DOI: 10.1093/neuonc/nou162.Peer-Reviewed Original ResearchConceptsProgression-free survivalClinical courseEpendymoma patientsMultivariate Cox proportional hazards modelMultivariate Cox proportional hazardsCox proportional hazards modelRare CNS tumorsTime of diagnosisPrognostic clinical factorsCox proportional hazardsProportional hazards modelSubtotal resectionClinical factorsMedian timeCNS tumorsCentral reviewGrade IIIMean ageTumor recurrenceEarly progressionTumor locationGrade IITumor gradeUnivariate analysisSupratentorial location
2013
Tumor pharmacokinetics (PK) and pharmacodynamics (PD) of SAR245409 (XL765) and SAR245408 (XL147) administered as single agents to patients with recurrent glioblastoma (GBM): An Ivy Foundation early-phase clinical trials consortium study.
Cloughesy T, Mischel P, Omuro A, Prados M, Wen P, Wu B, Rockich K, Xu Y, Lager J, Mellinghoff I. Tumor pharmacokinetics (PK) and pharmacodynamics (PD) of SAR245409 (XL765) and SAR245408 (XL147) administered as single agents to patients with recurrent glioblastoma (GBM): An Ivy Foundation early-phase clinical trials consortium study. Journal Of Clinical Oncology 2013, 31: 2012-2012. DOI: 10.1200/jco.2013.31.15_suppl.2012.Peer-Reviewed Original ResearchPan-PI3K inhibitorCohort 1Cohort 2Frozen tumor tissueTumor tissueTumor samplesK inhibitorsArchived tumor samplesPK/PD analysisPI3K/mTOR pathwayPD analysisTreatment of glioblastomaInhibition of proliferationPI3K inhibitorsPharmacodynamic impactEarly surgeryLast doseSurgical resectionCNS tumorsMean tumorRecurrent glioblastomaTumor resectionFFPE tumor samplesPK analysisCohort 3