Phase I Safety and Clinical Activity Study of Thymoquinone in Patients with Advanced Refractory Malignant Disease.

[摘要] Purpose::ThisphaseIstudywasconductedtodeterminethegeneraltoxicitiesofthymoquinoneinhumans,aswellasanyanti-cancereffectsthatthedrugmayhaveinpatientswithadvancedcancerforwhichtherewerenostandardcurativeorpalliativemeasures.Patientsandmethods::Adultpatientswithsolidtumorsorhematologicalmalignancieswhohadfailedorrelapsedfromstandardtherapywereincludedinthisstudy.Patientswhowereatleast18yearsofagewithanEasterncooperativeoncologygroupperformancestatus(ECOG)of≤2receivedthymoquinoneorallyatastartingdoselevelof3,7,or10mg/kg/day.DoseescalationproceededaccordingtoamodifiedFibonaccidesign.Results::All21patientsreceivedatleastoneweekoftreatment,withamedianof3.71weeks(range1weekto20weeks).Nosideeffectswerereportedandthemaximumtolerateddose(MDT)wasnotidentified.Noanti-cancereffectswereobserved.Conclusion::Onthebasisofthisstudy,thymoquinonewaswelltoleratedatadoserangingfrom75mg/dayto2600mg/day.Neithertoxicitiesnortherapeuticresponseswerereported.

[学科分类] 基础医学

[关键词] Thymoquinone;Cancer;Toxicity