2024
KS03.5.A EVALUATION OF VAL-083 IN GBM AGILE, A PHASE 3 REGISTRATION PLATFORM TRIAL FOR NEWLY DIAGNOSED AND RECURRENT GLIOBLASTOMA
Perry J, Cloughesy T, Berry D, Buxton M, Colman H, Ellingson B, Gordon G, Lassman A, Lim M, Mellinghoff I, Sulman E, Weller M, Wen P, Hyddmark E, Mikkelson T, Owen S, Mason W, Drappatz J, Blondin N, de Groot J. KS03.5.A EVALUATION OF VAL-083 IN GBM AGILE, A PHASE 3 REGISTRATION PLATFORM TRIAL FOR NEWLY DIAGNOSED AND RECURRENT GLIOBLASTOMA. Neuro-Oncology 2024, 26: v5-v5. PMCID: PMC11485821, DOI: 10.1093/neuonc/noae144.013.Peer-Reviewed Original ResearchEvaluation of VAL-083 in GBM AGILE, a phase 3 registration platform trial for newly diagnosed and recurrent glioblastoma.
de Groot J, Cloughesy T, Berry D, Buxton M, Colman H, Ellingson B, Gordon G, Lassman A, Lim M, Mellinghoff I, Sulman E, Weller M, Wen P, Hyddmark E, Mikkelsen T, Owen S, Mason W, Drappatz J, Blondin N, Perry J. Evaluation of VAL-083 in GBM AGILE, a phase 3 registration platform trial for newly diagnosed and recurrent glioblastoma. Journal Of Clinical Oncology 2024, 42: 2005-2005. DOI: 10.1200/jco.2024.42.16_suppl.2005.Peer-Reviewed Original ResearchOverall survivalHazard ratioBayesian predictive powerRandomized to CStage 1OS hazard ratioPromoter methylation statusSample sizeRecurrent glioblastomaIncreased OSEfficacy goalsInter-strand DNA crosslinksTargeted agentsRegistration trialsMultiple therapiesDNA double-strand breaksSubtypesDNA-targeting agentsPatient subtypesDouble-strand breaksGlioblastoma subtypesMethylation statusNDMRD
2023
An expanded safety/feasibility study of the EMulate Therapeutics Voyager™ System in patients with recurrent glioblastoma
Barkhoudarian G, Badruddoja M, Blondin N, Chowdhary S, Cobbs C, Duic J, Flores J, Fonkem E, McClay E, Nabors L, Salacz M, Taylor L, Vaillant B, Gill J, Kesari S. An expanded safety/feasibility study of the EMulate Therapeutics Voyager™ System in patients with recurrent glioblastoma. CNS Oncology 2023, 12: cns102. PMID: 37462385, PMCID: PMC10410686, DOI: 10.2217/cns-2022-0016.Peer-Reviewed Original ResearchConceptsMedian overall survivalProgression-free survivalOverall survivalRecurrent glioblastomaAdverse eventsTherapy groupMedian progression-free survivalDevice-related adverse eventsSafety/feasibilitySerious adverse eventsFurther prospective studiesConcurrent therapyInvestigator's discretionStandard chemotherapyProspective studyTRIAL REGISTRATIONPatientsMonthsTreatmentHome-use deviceGlioblastomaWeeksSurvivalTotalGroup
2019
ACTR-68. FEASIBILITY STUDY OF THE EMULATE THERAPEUTICS™ VOYAGER SYSTEM IN PATIENTS WITH RECURRENT GLIOBLASTOMA (GBM)
Barkhoudarian G, Badruddoja M, Blondin N, Chen R, Chowdhary S, Cobbs C, Dowling A, Duic P, Flores J, Fonkem E, McClay E, Nabors L, Salacz M, Vaillant B, Kesari S. ACTR-68. FEASIBILITY STUDY OF THE EMULATE THERAPEUTICS™ VOYAGER SYSTEM IN PATIENTS WITH RECURRENT GLIOBLASTOMA (GBM). Neuro-Oncology 2019, 21: vi29-vi29. PMCID: PMC6847970, DOI: 10.1093/neuonc/noz175.109.Peer-Reviewed Original ResearchSerious adverse eventsAdverse eventsRecurrent glioblastomaOverall survivalOutcome measuresDevice-related serious adverse eventsMedian overall survivalProgression-free survivalSecondary outcome measuresFurther prospective studiesPrimary outcome measureLong-term treatmentMulti-center studyAnti-cancer therapyProspective studyTreatment groupsFeasible treatmentPatientsBrain cancerInvestigator's choiceInvestigational deviceChemotherapyGlioblastomaMonthsTreatment