2024
rBMA: A robust Bayesian Model Averaging Method for phase II basket trials based on informative mixture priors
Wang X, Wei W. rBMA: A robust Bayesian Model Averaging Method for phase II basket trials based on informative mixture priors. Contemporary Clinical Trials 2024, 140: 107505. PMID: 38521384, DOI: 10.1016/j.cct.2024.107505.Peer-Reviewed Original ResearchConceptsPhase II basket trialRobust Bayesian modelBasket trial designBiomarker-defined subgroupsMixture priorsBinary endpointsModel averaging methodPosterior distributionBayesian modelBasket trialsSimulation studyEra of targeted therapyDevelopment of targeted agentsPriorsAverage methodGenomic alterationsPatient populationNovel treatmentAntitumor activityPosterior weightsEarly phase oncology trialsStatistical powerOncology trialsTrial designTrialsA generalized calibrated Bayesian hierarchical modeling approach to basket trials with multiple endpoints
Chi X, Yuan Y, Yu Z, Lin R. A generalized calibrated Bayesian hierarchical modeling approach to basket trials with multiple endpoints. Biometrical Journal 2024, 66: e2300122. PMID: 38368277, PMCID: PMC11323483, DOI: 10.1002/bimj.202300122.Peer-Reviewed Original ResearchConceptsBayesian hierarchical modeling approachShrinkage parameterTheoretical propertiesPhase II basket trialBasket trialsSimulation studyHierarchical modelHierarchical modeling approachFunctional formGeneral hierarchical modelEfficacy endpointLatent variable approachApproach yieldsRisk-benefit profileVariable approachImmunotherapy agentsTumor responseGeneralizationTargeted therapyCancer subtypesMultiple cancer subtypesTreatment effectsMonitoring procedures
2023
1990MO Sacituzumab govitecan (SG) as second-line (2L) treatment for extensive stage small cell lung cancer (ES-SCLC): Preliminary results from the phase II TROPiCS-03 basket trial
Dowlati A, Cervantes A, Babu S, Hamilton E, Wong S, Tazbirkova A, Sullivan I, de Lummen C, Italiano A, Patel J, Mekan S, Wu T, Chiang A. 1990MO Sacituzumab govitecan (SG) as second-line (2L) treatment for extensive stage small cell lung cancer (ES-SCLC): Preliminary results from the phase II TROPiCS-03 basket trial. Annals Of Oncology 2023, 34: s1061-s1062. DOI: 10.1016/j.annonc.2023.09.1221.Peer-Reviewed Original Research
2021
Ceralasertib-Mediated ATR Inhibition Combined With Olaparib in Advanced Cancers Harboring DNA Damage Response and Repair Alterations (Olaparib Combinations)
Mahdi H, Hafez N, Doroshow D, Sohal D, Keedy V, T. K, LoRusso P, Jürgensmeier J, Avedissian M, Sklar J, Glover C, Felicetti B, Dean E, Mortimer P, Shapiro GI, Eder JP. Ceralasertib-Mediated ATR Inhibition Combined With Olaparib in Advanced Cancers Harboring DNA Damage Response and Repair Alterations (Olaparib Combinations). JCO Precision Oncology 2021, 5: 1432-1442. PMID: 34527850, PMCID: PMC8437220, DOI: 10.1200/po.20.00439.Peer-Reviewed Original ResearchConceptsHigh-grade serous ovarian cancerComplete responseResponse rateClinical benefit ratePartial response ratePrimary end pointOverall response rateHomologous recombination repair deficiencySerous ovarian cancerPoly (ADP-ribose) polymerase (PARP) inhibitorsPrior therapyUnacceptable toxicityEntire cohortRefractory cancerBenefit rateOvarian cancerPromising therapyPatientsBasket trialsDay 1End pointOlaparibPolymerase inhibitorsTherapyAdditional studies
2020
Neratinib in patients with HER2-mutant, metastatic cervical cancer: Findings from the phase 2 SUMMIT basket trial
Oaknin A, Friedman CF, Roman LD, D’Souza A, Brana I, Bidard F, Goldman J, Alvarez EA, Boni V, ElNaggar AC, Passalacqua R, T.M. K, Santin AD, Keyvanjah K, Xu F, Eli LD, Lalani AS, Bryce RP, Hyman DM, Meric-Bernstam F, Solit DB, Monk BJ. Neratinib in patients with HER2-mutant, metastatic cervical cancer: Findings from the phase 2 SUMMIT basket trial. Gynecologic Oncology 2020, 159: 150-156. PMID: 32723675, PMCID: PMC8336424, DOI: 10.1016/j.ygyno.2020.07.025.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultDiarrheaFemaleHumansKaplan-Meier EstimateMiddle AgedMutationNauseaNeoplasm Recurrence, LocalProgression-Free SurvivalProtein Kinase InhibitorsQuinolinesReceptor, ErbB-2Response Evaluation Criteria in Solid TumorsSeverity of Illness IndexUterine Cervical NeoplasmsConceptsProgression-free survivalClinical benefit rateObjective response rateCervical cancerOverall survivalHER2 mutationsBasket trialsMetastatic/recurrent cervical cancerAdvanced/recurrent diseaseMedian progression-free survivalCommon HER2 mutationsGrade 3 diarrheaGrade 4 eventsHER2-mutant cancersSafety of neratinibCommon adverse eventsMedian overall survivalRecurrent cervical cancerMetastatic cervical cancerNew safety signalsPhase II basket trialPlatinum-based treatmentTyrosine kinase inhibitorsWarrants further investigationEligible patients
2019
Challenges and approaches to implementing master/basket trials in oncology
Burd A, Schilsky RL, Byrd JC, Levine RL, Papadimitrakopoulou VA, Herbst RS, Redman MW, Druker BJ, Gandara DR. Challenges and approaches to implementing master/basket trials in oncology. Blood Advances 2019, 3: 2237-2243. PMID: 31337605, PMCID: PMC6650731, DOI: 10.1182/bloodadvances.2019031229.Peer-Reviewed Original ResearchConceptsBasket trialsClinical trial designHealth care providersDifferent tumor typesTherapeutic optionsImmunologic reactionsCare providersDrug development effortsTrial designTumor typesPatientsMost cancersClinical researchNew therapeuticsCancer communityTherapy todayMedical institutionsCancerCancer researchTrialsRare mutationsEpigenetic changesHistologyOncologyAppetiteChallenges 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
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