Phase Ib study of dovitinib in combination with gemcitabine plus cisplatin or gemcitabine plus carboplatin in patients with advanced solid tumors
Galsky M, Posner M, Holcombe R, Lee K, Misiukiewicz K, Tsao C, Godbold J, Soto R, Gimpel-Tetra K, Lowe N, Oh W. Phase Ib study of dovitinib in combination with gemcitabine plus cisplatin or gemcitabine plus carboplatin in patients with advanced solid tumors. Cancer Chemotherapy And Pharmacology 2014, 74: 465-471. PMID: 25023489, PMCID: PMC4146643, DOI: 10.1007/s00280-014-2518-5.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesCarboplatinCisplatinColonic NeoplasmsDeoxycytidineDose-Response Relationship, DrugDrug Administration ScheduleFemaleGemcitabineHumansMaleMiddle AgedNeoplasmsNeutropeniaQuinolonesThromboembolismTreatment OutcomeUrinary Bladder NeoplasmsYoung AdultConceptsDose-limiting toxicityAdvanced solid tumorsGemcitabine plus carboplatinPhase Ib studyCycles of treatmentCarboplatin armCisplatin armSolid tumorsRecommended phase 2 doseVascular endothelial growth factor receptor familyDose-escalated armFrequent dose delaysLow dose cohortPhase 2 doseSevere thromboembolic eventsCombination of gemcitabineResponse to treatmentGrowth factor receptor familySmall molecule kinase inhibitorsDose escalation rulesAUC 5Dose cohortsDose delaysResultsFourteen patientsThromboembolic eventsPhase Ib/II trial of gemcitabine, cisplatin, plus lenalidomide as first-line therapy for patients with metastatic urothelial carcinoma.
Tsao C, Agarwal N, Apolo A, Lee K, Godbold J, Oh W, Galsky M. Phase Ib/II trial of gemcitabine, cisplatin, plus lenalidomide as first-line therapy for patients with metastatic urothelial carcinoma. Journal Of Clinical Oncology 2014, 32: 321-321. DOI: 10.1200/jco.2014.32.4_suppl.321.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaDose-limiting toxicityPhase II portionDay 1Dose delaysDose reductionUrothelial carcinomaDose of lenalidomidePhase 1b portionPhase Ib portionPhase Ib/II trialGrade 4 neutropeniaProgression-free survivalEfficacy of gemcitabineCisplatin-based chemotherapyFirst-line therapyDose escalation rulesDose delays/reductionsStable diseasePartial responseStandard chemotherapyTumor responseCytotoxic chemotherapyLimiting toxicitiesSlow accrual
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