2024
A phase I study of ATR inhibitor BAY1895344 (elimusertib) plus topotecan (ETCTN 10402): Results of dose escalation.
Stockton S, Shyr C, Cecchini M, Aljumaily R, Halfdanarson T, Sonbol M, Whisenant J, Ivy S, LoRusso P, Das S, Gore S, Berlin J, Beumer J, Heumann T. A phase I study of ATR inhibitor BAY1895344 (elimusertib) plus topotecan (ETCTN 10402): Results of dose escalation. Journal Of Clinical Oncology 2024, 42: 3076-3076. DOI: 10.1200/jco.2024.42.16_suppl.3076.Peer-Reviewed Original ResearchMaximum tolerated doseDose escalationDose levelsMedian progression-free survivalRecommended phase 2 doseRefractory advanced solid tumorsResults of dose escalationTreatment-related adverse eventsSmall cell lung cancerDisease control ratePhase 2 dosePhase Ia studyDose-limiting toxicityProgression-free survivalAdvanced solid tumorsPhase I studyCell lung cancerAnti-tumor activityExpansion cohortPartial responseTolerated doseTopotecan exposureStudy drugCancer xenograftsRespiratory failure
2019
Challenges with Novel Clinical Trial Designs: Master Protocols
Cecchini M, Rubin EH, Blumenthal GM, Ayalew K, Burris HA, Russell-Einhorn M, Dillon H, Lyerly HK, Reaman GH, Boerner S, LoRusso PM. Challenges with Novel Clinical Trial Designs: Master Protocols. Clinical Cancer Research 2019, 25: 2049-2057. PMID: 30696689, DOI: 10.1158/1078-0432.ccr-18-3544.Peer-Reviewed Original ResearchConceptsClinical trial designPlatform trialsMaster protocolsUmbrella trialsTrial designBasket trialsNovel clinical trial designsPanel of expertsMultiple investigational agentsInnovative clinical trial designsNovel clinical trialsInstitutional review boardDifferent tumor typesExpansion cohortInvestigational agentsSame histologyClinical trialsTumor typesBasket studyPatientsReview boardTrialsDrug development processDrug assessmentHistology