Phase I trial of ixabepilone administered as three oral doses each separated by 6 hours every 3 weeks in patients with advanced solid tumors
Kunz PL, He AR, Colevas AD, Pishvaian MJ, Hwang JJ, Clemens PL, Messina M, Kaleta R, Abrahao F, Sikic BI, Marshall JL. Phase I trial of ixabepilone administered as three oral doses each separated by 6 hours every 3 weeks in patients with advanced solid tumors. Investigational New Drugs 2012, 30: 2364-2370. PMID: 22331549, PMCID: PMC3703248, DOI: 10.1007/s10637-012-9800-3.Peer-Reviewed Original ResearchConceptsNeutropenic sepsisGrade 4 febrile neutropeniaDoses of ixabepiloneAdvanced solid tumorsExcellent performance statusPhase I trialSerial plasma samplesPlasma drug concentrationsRefractory advanced cancersHigh inter-individual variabilityFebrile neutropeniaPerformance statusI trialMedian ageAdvanced cancerInter-individual variabilityOral dosesSafety profileCohort 2Cohort 1Cohort 3PK variabilityOral formulationIxabepilonePatients