2021
Phase 1 Study of Entinostat and Nivolumab with or without Ipilimumab in Advanced Solid Tumors (ETCTN-9844)
Roussos Torres ET, Rafie C, Wang C, Lim D, Brufsky A, LoRusso P, Eder JP, Chung V, Downs M, Geare M, Piekarz R, Streicher H, Anforth L, Rudek MA, Zhu Q, Besharati S, Cimino-Mathews A, Anders RA, Stearns V, Jaffee EM, Connolly RM. Phase 1 Study of Entinostat and Nivolumab with or without Ipilimumab in Advanced Solid Tumors (ETCTN-9844). Clinical Cancer Research 2021, 27: clincanres.5017.2021. PMID: 34135021, PMCID: PMC8563383, DOI: 10.1158/1078-0432.ccr-20-5017.Peer-Reviewed Original ResearchConceptsCD8/FOXP3 ratioAdvanced solid tumorsAdverse eventsAddition of ICIFOXP3 ratioSolid tumorsGrade 3/4 adverse eventsRegulatory T cell ratioTreatment-related adverse eventsImmune checkpoint inhibitor efficacyTriple-negative breast cancerMulticenter phase I clinical trialPhase I clinical trialObjective response ratePhase II doseT cell ratioCheckpoint inhibitor efficacyPhase 1 studyCombination of entinostatHistone deacetylase inhibitor entinostatRECIST 1.1Primary endpointSecondary endpointsComplete responseDose escalation
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
2008
Phase I and Pharmacokinetic Study of Imatinib Mesylate in Patients With Advanced Malignancies and Varying Degrees of Liver Dysfunction: A Study by the National Cancer Institute Organ Dysfunction Working Group
Ramanathan R, Egorin M, Takimoto C, Remick S, Doroshow J, LoRusso P, Mulkerin D, Grem J, Hamilton A, Murgo A, Potter D, Belani C, Hayes M, Peng B, Ivy S. Phase I and Pharmacokinetic Study of Imatinib Mesylate in Patients With Advanced Malignancies and Varying Degrees of Liver Dysfunction: A Study by the National Cancer Institute Organ Dysfunction Working Group. Journal Of Clinical Oncology 2008, 26: 563-569. PMID: 18235115, DOI: 10.1200/jco.2007.11.0304.Peer-Reviewed Original ResearchConceptsNausea/vomitingLiver dysfunctionLiver functionLD groupNational Cancer Institute Organ Dysfunction Working GroupLiver function test elevationsPlasma concentration-time curveD dose levelDose of imatinibDoses of imatinibSevere liver dysfunctionDose-limiting toxicityMild liver dysfunctionSerum total bilirubinNormal liver functionPharmacokinetics of imatinibDose-normalized areaConcentration-time curveConcentrations of imatinibImatinib doseAdvanced malignanciesImatinib exposureMaximal doseImatinib mesylateRenal excretionPhase I and Pharmacokinetic Study of Imatinib Mesylate in Patients With Advanced Malignancies and Varying Degrees of Renal Dysfunction: A Study by the National Cancer Institute Organ Dysfunction Working Group
Gibbons J, Egorin M, Ramanathan R, Fu P, Mulkerin D, Shibata S, Takimoto C, Mani S, LoRusso P, Grem J, Pavlick A, Lenz H, Flick S, Reynolds S, Lagattuta T, Parise R, Wang Y, Murgo A, Ivy S, Remick S. Phase I and Pharmacokinetic Study of Imatinib Mesylate in Patients With Advanced Malignancies and Varying Degrees of Renal Dysfunction: A Study by the National Cancer Institute Organ Dysfunction Working Group. Journal Of Clinical Oncology 2008, 26: 570-576. PMID: 18235116, DOI: 10.1200/jco.2007.13.3819.Peer-Reviewed Original ResearchConceptsMaximum-tolerated doseSerious adverse eventsDose-limiting toxicityImatinib dosesGroup patientsRenal dysfunctionImatinib exposureNormal groupNational Cancer Institute Organ Dysfunction Working GroupAlpha-1-acid glycoprotein concentrationSerum alpha-1-acid glycoprotein concentrationsMild group patientsRenal dysfunction groupModerate renal dysfunctionAdvanced solid tumorsPharmacokinetics of imatinibAcid glycoprotein concentrationPlasma AGP concentrationImatinib clearanceImatinib dosePlasma imatinibStable diseaseDysfunction groupRenal impairmentAdult patients
2001
Chronic Oral Administration of CI-994: A Phase I Study
Prakash S, Foster B, Meyer M, Wozniak A, Heilbrun L, Flaherty L, Zalupski M, Radulovic L, Valdivieso M, LoRusso P. Chronic Oral Administration of CI-994: A Phase I Study. Investigational New Drugs 2001, 19: 1-11. PMID: 11291827, DOI: 10.1023/a:1006489328324.Peer-Reviewed Original ResearchConceptsHuman tumor xenograftsCI-994Dosing phaseStable diseaseTumor xenograftsNon-small cell lungNovel oral agentsChronic oral administrationDaily oral dosePeak plasma levelsRat leukemia modelOral agentsStarting doseDosage escalationGastrointestinal effectsDaily administrationOral doseCell lungPlasma levelsSingle dosesOral administrationRenal cancerChronic basisFood intakeTreatment duration
1996
Preclinical antitumor activity of CI-994
LoRusso P, Demchik L, Foster B, Knight J, Bissery M, Polin L, Leopold W, Corbett T. Preclinical antitumor activity of CI-994. Investigational New Drugs 1996, 14: 349-356. PMID: 9157069, DOI: 10.1007/bf00180810.Peer-Reviewed Original ResearchConceptsCI-994Prolonged administrationMammary adenocarcinomaClinical phase I trialColon adenocarcinomaPhase I trialHuman xenograft tumor modelsDays of administrationIndividual dosesPancreatic ductal adenocarcinomaPreclinical antitumor activityShort-term therapyLower drug dosesXenograft tumor modelHigher individual dosesI trialOsteogenic sarcomaDuctal adenocarcinomaNovel antitumor agentsDrug dosesAdenocarcinomaSolid tumorsTotal doseGross toxicityTumor model