2020
SGNLVA-001: A phase I open-label dose escalation and expansion study of SGN-LIV1A administered weekly in breast cancer.
Beckwith H, Medgyesy D, Abraham J, Nanda R, Tkaczuk K, Krop I, Pusztai L, Modi S, Mita M, Specht J, Hurvitz S, Han H, Kalinsky K, Wilks S, O'Shaughnessy J, Hart L, Rugo H, Mitri Z, Garfin P, Burris III H. SGNLVA-001: A phase I open-label dose escalation and expansion study of SGN-LIV1A administered weekly in breast cancer. Journal Of Clinical Oncology 2020, 38: tps1104-tps1104. DOI: 10.1200/jco.2020.38.15_suppl.tps1104.Peer-Reviewed Original ResearchMetastatic breast cancerMonomethyl auristatin EDose-expansion cohortsAntibody-drug conjugatesDose escalationBreast cancerRECIST v1.1Expansion cohortPrior linesCytotoxic chemotherapyMetastatic triple-negative breast cancerGrade 2 peripheral neuropathyInvestigational antibody-drug conjugateNegative metastatic breast cancerLIV-1Triple-negative breast cancerAdequate organ functionHumanized IgG1 monoclonal antibodyKey efficacy endpointsPrimary safety endpointProgression-free survivalDose-limiting toxicityDuration of responseOverall response rateMonths of completion
2003
Phase I and II study of exisulind in combination with capecitabine in patients with metastatic breast cancer.
Pusztai L, Zhen JH, Arun B, Rivera E, Whitehead C, Thompson WJ, Nealy KM, Gibbs A, Symmans WF, Esteva FJ, Booser D, Murray JL, Valero V, Smith TL, Hortobagyi GN. Phase I and II study of exisulind in combination with capecitabine in patients with metastatic breast cancer. Journal Of Clinical Oncology 2003, 21: 3454-61. PMID: 12972520, DOI: 10.1200/jco.2003.02.114.Peer-Reviewed Original ResearchMeSH Keywords3',5'-Cyclic-GMP PhosphodiesterasesAdultAgedAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCapecitabineCyclic Nucleotide Phosphodiesterases, Type 2Cyclic Nucleotide Phosphodiesterases, Type 5DeoxycytidineFemaleFluorouracilHumansImmunohistochemistryMiddle AgedNeoplasm MetastasisPhosphoric Diester HydrolasesProdrugsSulindacConceptsMetastatic breast cancerHand-foot syndromeAdverse eventsBreast cancerGrade 2Strong stainingPhase IContinuous daily therapyFrequent grade 2Dose-limiting toxicityOverall clinical benefitPercent of tumorsUnexpected adverse eventsPhase II testingBID dosePrevious anthracyclineStable diseaseDaily therapyTaxane chemotherapyLaboratory abnormalitiesMedian durationPartial responseClinical benefitTumor responseImmunohistochemical assessment
2000
Novel marine-derived anticancer agents: a phase I clinical, pharmacological, and pharmacodynamic study of dolastatin 10 (NSC 376128) in patients with advanced solid tumors.
Madden T, Tran H, Beck D, Huie R, Newman R, Pusztai L, Wright J, Abbruzzese J. Novel marine-derived anticancer agents: a phase I clinical, pharmacological, and pharmacodynamic study of dolastatin 10 (NSC 376128) in patients with advanced solid tumors. Clinical Cancer Research 2000, 6: 1293-301. PMID: 10778954.Peer-Reviewed Original ResearchConceptsConcentration-time curveDose levelsPhase IMajor nonhematological toxicityAntitumor activityAdvanced solid tumorsDose-limiting toxicityPlasma concentration-time dataEpisodes of thrombocytopeniaRapid distribution phaseParent drug concentrationsConcentration-time dataPercentage of declineVivo tumor modelsNonhematological toxicitiesObjective responseTwo-compartment modelSevere anemiaClinical PharmacokineticsCytokine supportPlasma levelsIntrapatient variabilityClinical dataNovel agentsPharmacodynamic studies