2015
SU2C Phase Ib Study of Paclitaxel and MK-2206 in Advanced Solid Tumors and Metastatic Breast Cancer
Gonzalez-Angulo AM, Krop I, Akcakanat A, Chen H, Liu S, Li Y, Culotta KS, Tarco E, Piha-Paul S, Moulder-Thompson S, Velez-Bravo V, Sahin AA, Doyle LA, Do KA, Winer EP, Mills GB, Kurzrock R, Meric-Bernstam F. SU2C Phase Ib Study of Paclitaxel and MK-2206 in Advanced Solid Tumors and Metastatic Breast Cancer. Journal Of The National Cancer Institute 2015, 107: dju493. PMID: 25688104, PMCID: PMC4342675, DOI: 10.1093/jnci/dju493.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsDrug Administration ScheduleDrug EruptionsFatigueFemaleHeterocyclic Compounds, 3-RingHumansHyperglycemiaMaleMaximum Tolerated DoseMiddle AgedNeoplasmsNeutropeniaPaclitaxelSeverity of Illness IndexTreatment OutcomeConceptsDose escalationDay 1Day 2Higher adverse eventsPhase Ib studyWeeks of therapyAdvanced solid tumorsCTCAE grade 3Metastatic breast cancerPrevious phase IPreliminary antitumor activityDose expansionStable diseaseObjective responseUnacceptable toxicityAdverse eventsMedian ageWeekly dosesClinical benefitPharmacodynamic markersSystemic exposureExcessive toxicityTumor responseGrade 3Median number
1997
Pharmacokinetics and clinical impact of all-trans retinoic acid in metastatic breast cancer: a phase II trial
Sutton L, Warmuth M, Petros W, Winer E. Pharmacokinetics and clinical impact of all-trans retinoic acid in metastatic breast cancer: a phase II trial. Cancer Chemotherapy And Pharmacology 1997, 40: 335-341. PMID: 9225952, DOI: 10.1007/s002800050666.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerBreast cancerTrans retinoic acidSystemic exposureMonths durationClinical pharmacologyPharmacokinetic analysisInitial systemic exposureM2 three timesCycles of therapyPhase II studyPhase II trialRetinoic acidStable diseaseII trialTumor cytoreductionUnacceptable toxicityFirst doseII studyPartial responsePatient withdrawalProgressive diseaseTreatment regimenInitial doseSingle institution