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
2009
A phase I study investigating the combination of orally bioavailable platinum and nanoparticle albumin-bound paclitaxel in advanced solid tumors
Deshpande H, Gettinger S, Rowen E, Abu-Khalaf M, Clarke J, Burns A, Kelly W. A phase I study investigating the combination of orally bioavailable platinum and nanoparticle albumin-bound paclitaxel in advanced solid tumors. Journal Of Clinical Oncology 2009, 27: e13501-e13501. DOI: 10.1200/jco.2009.27.15_suppl.e13501.Peer-Reviewed Original ResearchNanoparticle albumin-bound paclitaxelAlbumin-bound paclitaxelCohort 2Cohort 3Cohort 1Platinum agentsSolid tumorsDay 14Common severe adverse eventsGrade 3 anemiaMedian age 51Grade 4 neutropeniaStandard chemotherapy regimenAdvanced solid tumorsPhase 2 studySevere adverse eventsNeurological side effectsCycle 1Stable diseaseChemotherapy regimenDay 1 treatmentAdvanced malignanciesAdverse eventsPartial responseProgressive disease