2019
Phase I Study of AMG 337, a Highly Selective Small-molecule MET Inhibitor, in Patients with Advanced Solid Tumors
Hong DS, LoRusso P, Hamid O, Janku F, Kittaneh M, Catenacci DVT, Chan E, Bekaii-Saab T, Gadgeel S, Loberg RD, Amore BM, Hwang YC, Tang R, Ngarmchamnanrith G, Kwak EL. Phase I Study of AMG 337, a Highly Selective Small-molecule MET Inhibitor, in Patients with Advanced Solid Tumors. Clinical Cancer Research 2019, 25: 2403-2413. PMID: 30425090, PMCID: PMC6892342, DOI: 10.1158/1078-0432.ccr-18-1341.Peer-Reviewed Original ResearchMeSH KeywordsHumansMaximum Tolerated DoseNeoplasmsProtein Kinase InhibitorsPyridonesTreatment OutcomeTriazolesConceptsTreatment-related adverse eventsAdvanced solid tumorsAMG 337Adverse eventsFrequent treatment-related adverse eventsResponse rateSolid tumorsOpen-label phase ISmall-molecule MET inhibitorDose-escalation cohortsObjective response ratePhase II dosePromising response ratesDose-limiting toxicityMaximum plasma concentrationTumors warrants further investigationWarrants further investigationManageable toxicityDose expansionPrimary endpointSecondary endpointsDaily dosingMedian durationClinical responseMET inhibitors
2017
A Phase I/Ib Study of Enzalutamide Alone and in Combination with Endocrine Therapies in Women with Advanced Breast Cancer
Schwartzberg LS, Yardley D, Elias A, Patel M, LoRusso P, Burris HA, Gucalp A, Peterson A, Blaney M, Steinberg J, Gibbons J, Traina TA. A Phase I/Ib Study of Enzalutamide Alone and in Combination with Endocrine Therapies in Women with Advanced Breast Cancer. Clinical Cancer Research 2017, 23: 4046-4054. PMID: 28280092, DOI: 10.1158/1078-0432.ccr-16-2339.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAnastrozoleAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBenzamidesBreast NeoplasmsCytochrome P-450 CYP3ADose-Response Relationship, DrugDrug-Related Side Effects and Adverse ReactionsFemaleHumansMiddle AgedNeoplasm StagingNitrilesPhenylthiohydantoinPostmenopauseReceptors, EstrogenReceptors, ProgesteroneTriazolesConceptsEndocrine therapyEnzalutamide monotherapyBreast cancerEstrogen receptor-positive/progesterone receptor-positive breast cancerProgesterone receptor-positive breast cancerCytochrome P450 3A4 inducerRandomized phase II studyReceptor-positive breast cancerDose-expansion cohortsEffect of enzalutamidePhase II studyAdvanced breast cancerAndrogen receptor signalingBreast cancer modelClin Cancer ResDose modificationII studyPharmacokinetic interactionsPreclinical dataProstate cancerIb studyAdditional cohortMonotherapyCancer modelExemestane