2013
A Phase I dose-escalation study of the VEGFR inhibitor tivozanib hydrochloride with weekly paclitaxel in metastatic breast cancer
Mayer EL, Scheulen ME, Beckman J, Richly H, Duarte A, Cotreau MM, Strahs AL, Agarwal S, Steelman L, Winer EP, Dickler MN. A Phase I dose-escalation study of the VEGFR inhibitor tivozanib hydrochloride with weekly paclitaxel in metastatic breast cancer. Breast Cancer Research And Treatment 2013, 140: 331-339. PMID: 23868188, DOI: 10.1007/s10549-013-2632-9.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDose-Response Relationship, DrugDrug-Related Side Effects and Adverse ReactionsFemaleHumansMiddle AgedNeoplasm MetastasisPaclitaxelPhenylurea CompoundsProtein Kinase InhibitorsQuinolinesVascular Endothelial Growth Factor Receptor-1ConceptsMetastatic breast cancerTyrosine kinase inhibitorsWeekly paclitaxelPaclitaxel 90Breast cancerPhase I dose-escalation studyI dose-escalation studyVascular endothelial growth factor receptor 1Activity of tivozanibSafety/tolerabilityGrade 3/4 toxicitiesPeripheral sensory neuropathyPhase Ib studyDose-escalation studyResponse Evaluation CriteriaSelective tyrosine kinase inhibitorVEGFR-TKI treatmentSolid Tumors responseGrowth factor receptor 1Influence of paclitaxelFactor receptor 1Stable diseaseMBC patientsPartial responseProgressive disease
2011
P3-16-05: A Phase II Trial Expansion Cohort of the PARP Inhibitor Veliparib (ABT888) and Temozolomide in BRCA1/2 Associated Metastatic Breast Cancer.
Isakoff S, Overmoyer B, Tung N, Gelman R, Habin K, Qian J, Giranda V, Shepherd S, Garber J, Ellisen L, Winer E, Goss P. P3-16-05: A Phase II Trial Expansion Cohort of the PARP Inhibitor Veliparib (ABT888) and Temozolomide in BRCA1/2 Associated Metastatic Breast Cancer. Cancer Research 2011, 71: p3-16-05-p3-16-05. DOI: 10.1158/0008-5472.sabcs11-p3-16-05.Peer-Reviewed Original ResearchMetastatic breast cancerClinical benefit ratePrior platinum treatmentExpansion cohortResponse rateBenefit ratePlatinum treatmentPo bidPrior platinumMedian PFSAdditional patientsOriginal cohortBreast cancerCommon grade 3/4 toxicitiesSingle-arm phase II trialArm phase II trialBreast cancer xenograft modelPARP inhibitor veliparibPrior adjuvant chemotherapySafety of temozolomideGrade 3/4 toxicitiesPhase II studyFirst-line therapyPhase II trialOverall response rate
2006
Combination therapy with gefitinib and capecitabine in metastatic breast cancer (MBC): A phase I trial
Mayer E, Harris L, Partridge A, Gelman R, Schumer S, Comanaru R, Long M, Sampson E, Burstein H, Winer E. Combination therapy with gefitinib and capecitabine in metastatic breast cancer (MBC): A phase I trial. Journal Of Clinical Oncology 2006, 24: 10564-10564. DOI: 10.1200/jco.2006.24.18_suppl.10564.Peer-Reviewed Original ResearchMetastatic breast cancerMicroelectronic monitoring systemOral regimenValidation cohortDose reductionHand/foot syndromeSubstantial anti-tumor activityEGFR tyrosine kinase inhibitor gefitinibPhase IDose-escalation cohortsGrade 3 diarrheaGrade 4 toxicityCycles of therapyGrade 3 toxicityGrade 3/4 toxicitiesPhase I trialTyrosine kinase inhibitor gefitinibPost-therapy valuesMean numberCycle 1Lack of progressionAnti-tumor activityKinase inhibitor gefitinibEvaluable ptsUnresolved toxicity