2020
A Phase 1 study of RO6870810, a novel bromodomain and extra-terminal protein inhibitor, in patients with NUT carcinoma, other solid tumours, or diffuse large B-cell lymphoma
Shapiro GI, LoRusso P, Dowlati A, T. Do K, Jacobson CA, Vaishampayan U, Weise A, Caimi PF, Eder JP, French CA, Labriola-Tompkins E, Boisserie F, Pierceall WE, Zhi J, Passe S, DeMario M, Kornacker M, Armand P. A Phase 1 study of RO6870810, a novel bromodomain and extra-terminal protein inhibitor, in patients with NUT carcinoma, other solid tumours, or diffuse large B-cell lymphoma. British Journal Of Cancer 2020, 124: 744-753. PMID: 33311588, PMCID: PMC7884382, DOI: 10.1038/s41416-020-01180-1.Peer-Reviewed Original ResearchConceptsLarge B-cell lymphomaPhase 1 studyB-cell lymphomaSolid tumorsCommon treatment-related adverse eventsTreatment-related adverse eventsPeripheral blood mononuclear cellsInjection site erythemaObjective response rateSingle-agent activityBlood mononuclear cellsExtra-terminal (BET) protein inhibitorsSmall-molecule BET inhibitorsConclusionsThis trialAdverse eventsPharmacodynamic assessmentMononuclear cellsNUT carcinomaCD11b levelsExtra-terminal (BET) proteinsClinical trialsTestis carcinomaSustained decreaseFavorable pharmacokineticsPharmacokinetic parameters
2016
Drug interactions between buprenorphine, methadone and hepatitis C therapeutics
Ogbuagu O, Friedland G, Bruce RD. Drug interactions between buprenorphine, methadone and hepatitis C therapeutics. Expert Opinion On Drug Metabolism & Toxicology 2016, 12: 721-731. PMID: 27140427, DOI: 10.1080/17425255.2016.1183644.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsDirect acting antiviralsOpioid use disorderDrug interactionsUse disordersHCV direct acting antiviralsNovel direct acting antiviralsHepatitis C virus infectionHepatitis C therapeuticsHigh HCV prevalenceC virus infectionMedication-Assisted TherapyPharmacodynamic drug interactionsSpecific drug combinationsDrug package insertsHCV prevalenceHCV infectionHCV treatmentOpioid withdrawalActing antiviralsCombination regimenPharmacodynamic assessmentConcurrent administrationDrug levelsHigh prevalenceVirus infection
2015
Phase 1b study of the mammalian target of rapamycin inhibitor sirolimus in combination with nanoparticle albumin–bound paclitaxel in patients with advanced solid tumors
Abu-Khalaf MM, Baumgart MA, Gettinger SN, Doddamane I, Tuck DP, Hou S, Chen N, Sullivan C, Lezon-Geyda K, Zelterman D, Hatzis C, Deshpande H, Digiovanna MP, Azodi M, Schwartz PE, Harris LN. Phase 1b study of the mammalian target of rapamycin inhibitor sirolimus in combination with nanoparticle albumin–bound paclitaxel in patients with advanced solid tumors. Cancer 2015, 121: 1817-1826. PMID: 25649370, DOI: 10.1002/cncr.29254.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityIntravenous nab-paclitaxelPhase 1b studyAdvanced solid tumorsNab-paclitaxelFDG activityDay 1Solid tumorsNanoparticle albumin-bound paclitaxelMammalian targetWeekly oral doseAcceptable safety profileRapamycin inhibitor sirolimusAlbumin-bound paclitaxelClinical trial endpointsExploratory gene expression analysisPositron emission tomographyStable diseaseTaxane therapyPartial responseWeekly doseComplete responseOral sirolimusPharmacodynamic assessmentOral dose
2002
Pharmacodynamic studies of the epidermal growth factor receptor inhibitor ZD1839 in skin from cancer patients: histopathologic and molecular consequences of receptor inhibition.
Albanell J, Rojo F, Averbuch S, Feyereislova A, Mascaro J, Herbst R, LoRusso P, Rischin D, Sauleda S, Gee J, Nicholson R, Baselga J. Pharmacodynamic studies of the epidermal growth factor receptor inhibitor ZD1839 in skin from cancer patients: histopathologic and molecular consequences of receptor inhibition. Journal Of Clinical Oncology 2002, 20: 110-24. PMID: 11773160, DOI: 10.1200/jco.2002.20.1.110.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAntineoplastic AgentsApoptosisBiomarkersCell Cycle ProteinsCyclin-Dependent Kinase Inhibitor p27Dose-Response Relationship, DrugErbB ReceptorsFemaleGefitinibHumansKeratinocytesMaleMAP Kinase Signaling SystemMiddle AgedNeoplasmsQuinazolinesSkinStatistics, NonparametricTumor Suppressor ProteinsConceptsCancer patientsEpidermal growth factor receptor tyrosine kinase inhibitor ZD1839Tyrosine kinase inhibitor ZD1839Phase I clinical trialMaximum-tolerated doseDose-limiting toxicityEGFR activationReceptor-dependent processUnacceptable toxicityDefinitive efficacyPharmacodynamic assessmentSafety trialPharmacodynamic effectsClinical trialsKeratin plugsReceptor inhibitionMaturation markersSkin biopsiesPharmacodynamic studiesProliferation indexDose levelsOral ZD1839PatientsOptimal dosesZD1839
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