2023
First-in-class oral innate immune activator BXCL701 combined with pembrolizumab, in patients with metastatic castration-resistant prostate cancer (mCRPC) of small cell neuroendocrine (SCNC) variant: Randomized phase 2b trial.
Aggarwal R, Zhang J, Monk P, Zhu X, Costin D, Petrylak D, Borderies P, Deshpande R, Hafeez A, O'Neill V, Tagawa S. First-in-class oral innate immune activator BXCL701 combined with pembrolizumab, in patients with metastatic castration-resistant prostate cancer (mCRPC) of small cell neuroendocrine (SCNC) variant: Randomized phase 2b trial. Journal Of Clinical Oncology 2023, 41: tps5109-tps5109. DOI: 10.1200/jco.2023.41.16_suppl.tps5109.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerSerious adverse eventsPartial responsePrimary endpointPhase 2aRandomized Phase 2b TrialCastration-resistant prostate cancerOral small-molecule inhibitorPhase 2b trialPrime immune cellsRECIST 1.1 criteriaDisease control rateImmune checkpoint inhibitorsPhase 2 studyPlatinum-based chemotherapyDuration of responsePotential predictive biomarkersImmune effector cellsMeasurable diseaseNeuroendocrine variantPSA-PFSRECIST 1.1Safety populationCheckpoint inhibitorsData cutoff
2007
Phase II multicenter, two-stage study of E7389 in patients with hormone refractory prostate cancer with advanced and/or metastatic disease stratified by prior chemotherapy
Molife R, Cartwright T, Loesch D, Garbo L, Sonpavde G, Calvo E, Das A, Wanders J, Petrylak D, de Bono J. Phase II multicenter, two-stage study of E7389 in patients with hormone refractory prostate cancer with advanced and/or metastatic disease stratified by prior chemotherapy. Journal Of Clinical Oncology 2007, 25: 15513-15513. DOI: 10.1200/jco.2007.25.18_suppl.15513.Peer-Reviewed Original ResearchHormone-refractory prostate cancerRefractory prostate cancerPSA responsePrior chemotherapyProstate cancerNon-small cell lung cancerSmall cell lung cancerPhase II multicenterRefractory breast cancerSerious adverse eventsSingle-agent activityCell lung cancerProstate cancer cell linesBolus IV infusionTwo-stage studyConcomitant steroidsCancer cell linesChest painFebrile neutropeniaStudy drugAcceptable toxicityMetastatic diseasePrior regimenRenal failureAdverse events
2006
Reduced thromboembolic events with DN-101 (high-dose calcitriol) treatment of androgen-independent prostate cancer: Hypothesis for a new class of anticoagulants
Venner P, Ryan C, Petrylak D, Chatta G, Ruether J, Chi K, Curd J, Beer T. Reduced thromboembolic events with DN-101 (high-dose calcitriol) treatment of androgen-independent prostate cancer: Hypothesis for a new class of anticoagulants. Journal Of Clinical Oncology 2006, 24: 4505-4505. DOI: 10.1200/jco.2006.24.18_suppl.4505.Peer-Reviewed Original ResearchAndrogen-independent prostate cancerSerious adverse eventsThromboembolic eventsDN-101Prostate cancerExact testMetastatic androgen-independent prostate cancerIncidence of TEPlacebo-controlled studyVDR knockout miceEffects of calcitriolFisher's exact testDocetaxel regimenPlacebo groupAdvanced malignanciesAdverse eventsVitamin DBaseline useEfficacy resultsGrade 3Study groupNatural anticoagulantsOral formulationKnockout micePatientsA Phase I Trial of Pox PSA vaccines (PROSTVAC®-VF) with B7-1, ICAM-1, and LFA-3 co-stimulatory molecules (TRICOM™) in Patients with Prostate Cancer
DiPaola R, Plante M, Kaufman H, Petrylak D, Israeli R, Lattime E, Manson K, Schuetz T. A Phase I Trial of Pox PSA vaccines (PROSTVAC®-VF) with B7-1, ICAM-1, and LFA-3 co-stimulatory molecules (TRICOM™) in Patients with Prostate Cancer. Journal Of Translational Medicine 2006, 4: 1. PMID: 16390546, PMCID: PMC1360095, DOI: 10.1186/1479-5876-4-1.Peer-Reviewed Original ResearchProstate-specific antigenSerious adverse eventsAdverse eventsProstate cancerB7-1ICAM-1Co-stimulatory molecules B7-1Mean prostate-specific antigenRecombinant vaccinia virus vaccineAndrogen-independent prostate cancerFurther phase IIPreliminary clinical activityInjection site reactionsPhase I trialVaccinia virus vaccineCo-stimulatory moleculesIndependent prostate cancerFeasible therapeutic approachRecombinant fowlpox virusStable diseaseMetastatic diseaseProgressive diseaseI trialTherapeutic vaccinesSafety profile