2020
BT8009-100 phase I/II study of the safety, pharmacokinetics, & preliminary clinical activity of BT8009 in patients with Nectin-4 expressing advanced malignancies
Mckean M, Bendell J, Petrylak D, Powles T, Sonpavde G, Dickson A, Dosunmu L, Hennessy M, Jeffrey P, Rigby M, West T. BT8009-100 phase I/II study of the safety, pharmacokinetics, & preliminary clinical activity of BT8009 in patients with Nectin-4 expressing advanced malignancies. Annals Of Oncology 2020, 31: s500-s501. DOI: 10.1016/j.annonc.2020.08.713.Peer-Reviewed Original Research
2016
Anti-tumor activity, safety and pharmacokinetics (PK) of ASG-22CE (ASG-22ME; enfortumab vedotin) in a phase I dose escalation trial in patients (Pts) with metastatic urothelial cancer (mUC).
Rosenberg J, Heath E, Van Veldhuizen P, Merchan J, Lang J, Ruether J, Petrylak D, Sangha R, Smith D, Sridhar S, Gartner E, Vincent M, Chu R, Anand B, Donate F, Jackson L, Reyno L, Zhang J. Anti-tumor activity, safety and pharmacokinetics (PK) of ASG-22CE (ASG-22ME; enfortumab vedotin) in a phase I dose escalation trial in patients (Pts) with metastatic urothelial cancer (mUC). Journal Of Clinical Oncology 2016, 34: 4533-4533. DOI: 10.1200/jco.2016.34.15_suppl.4533.Peer-Reviewed Original ResearchAnti-tumor activity, safety and pharmacokinetics (PK) of AGS15E (ASG-15ME) in a phase I dose escalation trial in patients (Pts) with metastatic urothelial cancer (mUC).
Petrylak D, Heath E, Sonpavde G, George S, Morgans A, Eigl B, Picus J, Cheng S, Hotte S, Gartner E, Vincent M, Chu R, Anand B, Morrison K, Jackson L, Reyno L, Yu E. Anti-tumor activity, safety and pharmacokinetics (PK) of AGS15E (ASG-15ME) in a phase I dose escalation trial in patients (Pts) with metastatic urothelial cancer (mUC). Journal Of Clinical Oncology 2016, 34: 4532-4532. DOI: 10.1200/jco.2016.34.15_suppl.4532.Peer-Reviewed Original Research
2009
Final results of a phase I study of oral belinostat (PXD101) in patients with solid tumors
Kelly W, DeBono J, Blumenschein G, Lassen U, Zain J, O'Connor O, Foss F, Tjornelund J, Fagerberg J, Petrylak D. Final results of a phase I study of oral belinostat (PXD101) in patients with solid tumors. Journal Of Clinical Oncology 2009, 27: 3531-3531. DOI: 10.1200/jco.2009.27.15_suppl.3531.Peer-Reviewed Original ResearchAdverse eventsFrequent related adverse eventsRelated adverse eventsMedian age 60Histone deacetylase inhibitorsMajor cancer typesMultiple tumor typesDaily x5Overall tolerabilityDose escalationQTc prolongationSafety profilePreclinical activityClinical activitySerial ECGsDay 1Age 60Solid tumorsTumor typesDeacetylase inhibitorsCohort 2aFurther evaluationPharmacokineticsCancer typesMultiple schedule
2006
Pharmacokinetics (PK), safety and tolerability of atrasentan (ABT-627, ATN) in combination with docetaxel (DOC) in men with hormone refractory prostate cancer (HRPC)
Petrylak D, Mohile S, Shelton G, Carr R, Steinberg J, Sleep D, Melia J, Rieser M, Nanus D, Milowsky M. Pharmacokinetics (PK), safety and tolerability of atrasentan (ABT-627, ATN) in combination with docetaxel (DOC) in men with hormone refractory prostate cancer (HRPC). Journal Of Clinical Oncology 2006, 24: 14512-14512. DOI: 10.1200/jco.2006.24.18_suppl.14512.Peer-Reviewed Original ResearchHormone-refractory prostate cancerPSA declineAdverse eventsTreatment of HRPCPhase III clinical developmentPhase III studyRefractory prostate cancerUnexpected adverse eventsDOC infusionNeutropenic feverIII studyLiver metastasesOral dosesPO QDSelective endothelinPK interactionsReceptor antagonistPlasma concentrationsProstate cancerCYP3A4 activityClinical developmentDay 1DocetaxelPK resultsPharmacokinetics