2016
Phase I study of safety and tolerability of sunitinib in combination with sirolimus in patients with refractory solid malignancies and determination of VEGF (VEGF-A) and soluble VEGF-R2 (sVEGFR2) in plasma
Li J, Kluger H, Devine L, Lee JJ, Kelly WK, Rink L, Saif MW. Phase I study of safety and tolerability of sunitinib in combination with sirolimus in patients with refractory solid malignancies and determination of VEGF (VEGF-A) and soluble VEGF-R2 (sVEGFR2) in plasma. Cancer Chemotherapy And Pharmacology 2016, 77: 1193-1200. PMID: 27103123, DOI: 10.1007/s00280-016-3033-7.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansIndolesMaleMaximum Tolerated DoseMiddle AgedNeoplasmsPyrrolesSirolimusSunitinibTOR Serine-Threonine KinasesVascular Endothelial Growth Factor AVascular Endothelial Growth Factor Receptor-2Young AdultConceptsRenal cell carcinomaComplete responseFourth cohortVEGF productionOral small-molecule inhibitorApparent pharmacokinetic interactionMedian age 57Prior systemic therapyRefractory solid malignanciesResidual renal massTolerability of sunitinibHand-foot syndromeHalf of patientsLymph node dissectionCombination of sunitinibPhase 1 studyDose of sunitinibOral mTOR inhibitorDose/scheduleUnknown compensatory mechanismsCycle 1Multiple receptor tyrosine kinasesAnti-tumor activityEpithelial growth factor receptor (EGFR) signalingTumor cell proliferation
2009
A phase I study of sunitinib in combination with sirolimus in adults with advanced refractory malignancies
Li J, Kluger H, Saif M, Murren J, Lee J, Kelly W, Rink L, Devine L, Sznol M. A phase I study of sunitinib in combination with sirolimus in adults with advanced refractory malignancies. Journal Of Clinical Oncology 2009, 27: 3554-3554. DOI: 10.1200/jco.2009.27.15_suppl.3554.Peer-Reviewed Original ResearchEarly discontinuationDose reductionDose levelsOral small-molecule inhibitorReceptor tyrosine kinasesAdvanced refractory malignanciesApparent PK interactionsHand-foot syndromeOral mTOR inhibitorDose/scheduleSoft tissue sarcomasDose of sirolimusMultiple receptor tyrosine kinasesAnti-tumor activityTumor cell proliferationDose cohortsECOG PSSunitinib doseInterstitial pneumonitisProgressive diseaseDose escalationTargeted agentsRefractory malignanciesTissue sarcomasPK interactions