2018
Multicenter Phase IB Trial of Carboxyamidotriazole Orotate and Temozolomide for Recurrent and Newly Diagnosed Glioblastoma and Other Anaplastic Gliomas.
Omuro A, Beal K, McNeill K, Young RJ, Thomas A, Lin X, Terziev R, Kaley TJ, DeAngelis LM, Daras M, Gavrilovic IT, Mellinghoff I, Diamond EL, McKeown A, Manne M, Caterfino A, Patel K, Bavisotto L, Gorman G, Lamson M, Gutin P, Tabar V, Chakravarty D, Chan TA, Brennan CW, Garrett-Mayer E, Karmali RA, Pentsova E. Multicenter Phase IB Trial of Carboxyamidotriazole Orotate and Temozolomide for Recurrent and Newly Diagnosed Glioblastoma and Other Anaplastic Gliomas. Journal Of Clinical Oncology 2018, 36: 1702-1709. PMID: 29683790, PMCID: PMC5993168, DOI: 10.1200/jco.2017.76.9992.Peer-Reviewed Original ResearchConceptsAnaplastic gliomasCohort 2Cohort 1Median progression-free survivalFavorable brain penetrationMedian overall survivalPhase Ib studyPhase Ib trialPhase II doseProgression-free survivalRecurrent anaplastic gliomasDependent calcium channelsNovel oral inhibitorSignal of activityMismatch repair genesIb trialTreat populationMethylguanine-DNA methyltransferaseOverall survivalComplete responseFlat doseOral inhibitorBrain penetrationResults FortyTherapeutic concentrations
2014
AT-35INTERMITTENT HIGH DOSE (PULSATILE) ERLOTINIB FOR EGFRvIII MUTANT RECURRENT MALIGNANT GLIOMAS: A PILOT CLINICAL TRIAL
Lassman A, Grommes C, Panageas K, Iwamoto F, DeAngelis L, Kaley T, Gavrilovic I, Pentsova E, Omuro A, Corpuz C, Briggs S, Otap D, Qin W, Cross J, Mellinghoff I. AT-35INTERMITTENT HIGH DOSE (PULSATILE) ERLOTINIB FOR EGFRvIII MUTANT RECURRENT MALIGNANT GLIOMAS: A PILOT CLINICAL TRIAL. Neuro-Oncology 2014, 16: v16-v16. PMCID: PMC4217814, DOI: 10.1093/neuonc/nou237.35.Peer-Reviewed Original ResearchRecurrent malignant gliomaMalignant gliomasInhibitor therapyHigh-dose erlotinibOngoing complete responseEGFR-TKI erlotinibPopulation of patientsMedian age 58Pilot clinical trialInadequate drug deliveryKinase inhibitor therapyDose erlotinibEligible patientsPulsatile dosingAdverse eventsMedian survivalComplete responseDaily doseTKI erlotinibMedian CmaxAnaplastic gliomasClinical trialsAge 58Surgical armLimited efficacy