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
2014
Phase I Clinical Trial of the Mammalian Target of Rapamycin Inhibitor Everolimus in Combination With Oral Topotecan for Recurrent and Advanced Endometrial Cancer
Acevedo-Gadea C, Santin AD, Higgins SA, Urva S, Ratner E, Silasi DA, Azodi M, Rutherford T, Schwartz PE, Abu-Khalaf MM. Phase I Clinical Trial of the Mammalian Target of Rapamycin Inhibitor Everolimus in Combination With Oral Topotecan for Recurrent and Advanced Endometrial Cancer. International Journal Of Gynecological Cancer 2014, 24: 528-533. PMID: 24557436, DOI: 10.1097/igc.0000000000000085.Peer-Reviewed Original ResearchConceptsOral topotecanEndometrial cancerDay 1Pelvic external beam radiation therapyMammalian targetExternal beam radiation therapyPhase I clinical trialRecurrent endometrial cancerAdvanced endometrial cancerDose-limiting toxicityEfficacy of topotecanRapamycin inhibitor everolimusBeam radiation therapyOral everolimusStable diseaseVaginal brachytherapyMedian ageRapamycin inhibitorsInhibitor everolimusPreclinical dataClinical trialsMedian numberPharmacokinetic assessmentRadiation therapyEverolimus