A prospective study of relationship between osimertinib-induced QT prolongation and pharmacokinetics, pharmacogenetics - A study of relationship between osimertinib-induced QT prolongation and pharmacological factors

Showa University0 个研究点目标入组 50 人开始时间: 2020年12月5日最近更新: 2023年10月17日

适应症

试验速览

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•1. Patient who has symptomatic CNS metastasis. 2. Patient who has active synchronous cancer. 3. Patient who received osimertinib therapy before. 4. Patient who has interstitial lung disease. 5. Patient who has severe infection. 6. Positive for HBs antigen and/or HCV antibody. 7. Patient who has cardiovascular diseases, for example unstable angina, myocardial infarction, that have been developed within 3 months. 8. Patient who has cerebrovascular disease, for example cerebral infarction, that have been developed within 3 months. 9. Patient who has severe uncontrolled comorbidity. 10. Patient who is unable to participate in study due to psychological disorder. 11. Patient who has severe drug sensitivity or allergy. 12. Patient who takes medicine that affect CYP3A4 such as phenytoin, carbamazepine, rifampicin, phenobarbital, itraconazole, and macrolides. 13. Patient who has contraindication to osimertinib. 14. Pregnant, lactating women or women who may become pregnant, or men who wish to have children. 15. Patient who is inappropriate for conducting study safely.

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