Method for treating tumour, pharmaceutical composition and medicinal kit
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 tumors in a patient, the method comprising administering to a patient a daily dose of 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 via interval administration, wherein the interval administration includes administration periods and rest periods;
wherein the tumors are liver cancer, breast cancer, kidney cancer, colorectal cancer, non-small cell lung cancer, gastrointestinal stromal tumor, medullary thyroid carcinoma and soft tissue sarcoma.
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 2 , wherein the interval administration is performed via an administration regimen selected from the group consisting of:
continuous administration for 14 days and rest for 14 days, followed by continuous administration for 14 days and rest for 14 days;
continuous administration for 14 days and rest for 7 days, followed by continuous administration for 14 days and rest for 7 days; or
continuous administration for 5 days and rest for 2 days, followed by continuous administration for 5 days and rest for 2 days.
4. A method for treating tumors, the method comprising an interval administration 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 patients;
wherein the tumors are liver cancer, breast cancer, kidney cancer, colorectal cancer, non-small cell lung cancer, gastrointestinal stromal tumor, medullary thyroid carcinoma and soft tissue sarcoma.
5. The method according to claim 4 , wherein the plasma concentration of 1-[[[4-(4-fluoro-2-methyl-1H-indol-5-yl)oxy-6-methoxyquinolin-7-yl]oxy]methyl]cyclopropylamine is 100 ng/ml or lower.
6. The method according to claim 4 , wherein the interval administration includes administration periods and rest periods.
7. The method according to claim 6 , wherein the ratio of the administration periods to the rest periods in days is 2:0.5-5.
8. The method according to claim 7 , wherein the interval administration is performed via an administration regimen selected from the group consisting of:
continuous administration for 14 days and rest for 14 days, followed by continuous administration for 14 days and rest for 14 days;
continuous administration for 14 days and rest for 7 days, followed by continuous administration for 14 days and rest for 7 days; or
continuous administration for 5 days and rest for 2 days, followed by continuous administration for 5 days and rest for 2 days.
9. The method according to claim 4 , the daily dosage of 5 mg-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 is administrated.
10. A method for treating tumors, the method comprises an interval administration of a pharmaceutical composition comprising 5 mg-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 patients;
wherein the tumors are liver cancer, breast cancer, kidney cancer, colorectal cancer, non-small cell lung cancer, gastrointestinal stromal tumor, medullary thyroid carcinoma and soft tissue sarcoma.
11. The method according to claim 10 , wherein the pharmaceutical composition is formulated into a form of single dosage.
12. The method according to claim 10 , wherein the pharmaceutical composition is administrated to the patients according to an administration regimen selected from the group consisting of:
continuous administrating for 2 weeks and resting for 2 weeks;
continuous administrating for 2 weeks and resting for 1 week; and/or
continuous administrating for 5 days and resting for 2 days.
13. The method according to claim 10 , wherein the pharmaceutical composition is tablets or capsules suitable for oral administration.
14. The method according to claim 10 , wherein the pharmaceutical composition is administered once daily according to the regimen of continuously administrating for 2 weeks and resting for 1 week.
15. The method according to claim 10 , wherein the method comprises an interval administration of a pharmaceutical composition comprising 5 mg-20 mg of 1-[[[4-(4-fluoro-2-methyl-1H-indol-5-yl)oxy-6-methoxyquinolin-7-yl]oxy]methyl]cyclopropylamine dihydrochloride to patients.