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

lranian journal of Clinical Infectious Diseases

Ali M. Al-Amri, MD²  Abdullah O. Bamosa MBBS, PHD¹ 

[1] Department of Physiology, College of Medicine, King Faisal University, Dammam, Saudi Arabia.;Department of Internal Medicine/Oncology, College of Medicine, King Faisal University, King Fahd Hospital of the University, Al-Khobar, Eastern Province, Kingdom of Saudi Arabia.

关键词: Thymoquinone;    Cancer;    Toxicity;   

DOI  :  10.17795/semj20501

学科分类：基础医学

来源: Shiraz University of Medical Sciences

【 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.

【 授权许可】

Unknown