Method for treating tumour, pharmaceutical composition and medicinal kit

Abstract

The present invention provides 1-[[[4-(4-fluoro-2-methyl-1H-indol-5-yl)oxy-6-methoxyquinolin-7-yl]oxy]methyl]cyclopro-pylamine used for combating a tumor. Specially, the present invention refers to method for treating tumor, pharmaceutical composition and medicinal kit related to the described compound. Administrating the compound with a suitable dosage regimen can not only make the patient's plasma concentration maintain the level of 100 ng/ml or lower, but also achieve effects of treatments and obtain benefits for various tumours.

1 . A method for treating a patient with tumors, the method comprising administering a pharmaceutical composition comprising 5 mg to 20 mg of 1-[[[4-(4-fluoro-2-methyl-1H-indol-5-yl)oxy-6-methoxyquinolin-7-yl]oxy] methyl] cyclopropylamine or a pharmaceutically acceptable salt thereof to the patient using an interval administration, wherein the interval administration includes administration periods and rest periods. 
     
     
         2 . The method according to  claim 1 , wherein the ratio of the administration periods to the rest periods in days is 2:0.5-5. 
     
     
         3 . The method according to  claim 1 , wherein the interval administration is performed via an administration regimen selected from continuous administration for 14 days and rest for 7 days. 
     
     
         4 . The method according to  claim 1 , comprising administering 8 mg to 12 mg of 1-[[[4-(4-fluoro-2-methyl-1H-indol-5-yl)oxy-6-methoxyquinolin-7-yl]oxy] methyl] cyclopropylamine or the pharmaceutically acceptable salt thereof. 
     
     
         5 . A method for treating a patient with tumors, the method comprising orally administering a pharmaceutical composition comprising 5 mg to 20 mg of 1-[[[4-(4-fluoro-2-methyl-1H-indol-5-yl)oxy-6-methoxyquinolin-7-yl]oxy] methyl] cyclopropylamine or a pharmaceutically acceptable salt thereof to the patient using an interval administration, wherein the interval administration includes administration periods and rest periods. 
     
     
         6 . The method according to  claim 5 , wherein the ratio of the administration periods to the rest periods in days is 2:0.5-5. 
     
     
         7 . The method according to  claim 5 , wherein the interval administration is performed via continuous administration for 14 days and rest for 7 days. 
     
     
         8 . The method according to  claim 7 , comprising administering 8 mg to 12 mg of 1-[[[4-(4-fluoro-2-methyl-1H-indol-5-yl)oxy-6-methoxyquinolin-7-yl]oxy] methyl] cyclopropylamine or the pharmaceutically acceptable salt thereof. 
     
     
         9 . The method according to  claim 7 , comprising administering 12 mg of 1-[[[4-(4-fluoro-2-methyl-1H-indol-5-yl)oxy-6-methoxyquinolin-7-yl]oxy] methyl] cyclopropylamine or the pharmaceutically acceptable salt thereof. 
     
     
         10 . The method according to  claim 7 , wherein the pharmaceutical composition is tablets or capsules. 
     
     
         11 . The method according to  claim 8 , comprising administering 8 mg to 12 mg of 1-[[[4-(4-fluoro-2-methyl-1H-indol-5-yl)oxy-6-methoxyquinolin-7-yl]oxy] methyl] cyclopropylamine dihydrochloride.