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Last Updated: April 27, 2024

Claims for Patent: 10,456,399

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Summary for Patent: 10,456,399

Title:	Method for treating cancer patients with severe renal impairment
Abstract:	A method for treating cancer in patients with creatinine clearance of 15 mL/min or more and less than 30 mL/min, including dividing a combination drug containing .alpha.,.alpha.,.alpha.-trifluorothymidine (FTD) and 5-chloro-6-[(2-iminopyrrolidine-1-yl)methyl]pyrimidine-2,4(1H,3H)-dione hydrochloride in a molar ratio of 1:0.5, in a dose of 30 to 50 mg/m.sup.2/day as FTD-equivalent, into two to four times a day, and orally administering it to the patient.
Inventor(s):	Yoshida; Kenichiro (Tsukuba, JP)
Assignee:	TAIHO PHARMACEUTICAL CO., LTD. (Chiyoda-ku, JP)
Application Number:	16/054,073
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,456,399
Patent Claims:	1. A method for treating cancer which is one of gastrointestinal cancer, large bowel cancer and breast cancer, comprising: detecting a creatinine clearance of a patient; and orally administering to the patient with a creatinine clearance of less than 30 mL/min a combination drug comprising .alpha.,.alpha.,.alpha.-trifluorothymidine (FTD) and 5-chloro-6-[(2-iminopyrrolidine-1-yl)methyl]pyrimidine-2,4(1H,3H)-dione hydrochloride in a molar ratio of 1:0.5, a daily dose of 30 to 40 mg/m.sup.2/day as FTD-equivalent, divided into two to four portions for administration. 2. The method for treating cancer according to claim 1, wherein the combination drug is administered to the patient with a creatinine clearance of 15 mL/min or more and 29 mL/min or less. 3. The method for treating cancer according to claim 1, wherein a dose of 40 mg/m.sup.2/day as FTD-equivalent is divided in two portions. 4. The method for treating cancer according to claim 1, wherein an administration schedule is 5-day consecutive oral administrations and 2-day rest, per week. 5. The method for treating cancer according to claim 1, wherein an administration schedule of 5-day consecutive oral administrations and 2-day rest is repeated twice, followed by rest for 14 days. 6. The method for treating cancer according to claim 1, wherein the cancer is gastrointestinal cancer or breast cancer. 7. The method for treating cancer according to claim 1, wherein the cancer is large bowel cancer. 8. The method for treating cancer according to claim 1, wherein the cancer is gastrointestinal cancer. 9. The method for treating cancer according to claim 1, wherein the cancer is breast cancer. 10. The method for treating cancer according to claim 2, wherein a dose of 40 mg/m.sup.2/day as FTD-equivalent is divided in two portions. 11. The method for treating cancer according to claim 2, wherein an administration schedule is 5-day consecutive oral administrations and 2-day rest, per week. 12. The method for treating cancer according to claim 2, wherein an administration schedule of 5-day consecutive oral administrations and 2-day rest is repeated twice, followed by rest for 14 days. 13. The method for treating cancer according to claim 2, wherein the cancer is gastrointestinal cancer or breast cancer. 14. The method for treating cancer according to claim 2, wherein the cancer is large bowel cancer. 15. The method for treating cancer according to claim 2, wherein the cancer is gastrointestinal cancer. 16. The method for treating cancer according to claim 2, wherein the cancer is breast cancer. 17. The method for treating cancer according to claim 3, wherein an administration schedule is 5-day consecutive oral administrations and 2-day rest, per week. 18. The method for treating cancer according to claim 3, wherein an administration schedule of 5-day consecutive oral administrations and 2-day rest is repeated twice, followed by rest for 14 days. 19. The method for treating cancer according to claim 3, wherein the cancer is gastrointestinal cancer or breast cancer. 20. The method for treating cancer according to claim 3, wherein the cancer is large bowel cancer. 21. The method for treating cancer according to claim 3, wherein the cancer is gastrointestinal cancer. 22. The method for treating cancer according to claim 3, wherein the cancer is breast cancer. 23. The method for treating cancer according to claim 4, wherein the cancer is gastrointestinal cancer or breast cancer. 24. The method for treating cancer according to claim 4, wherein the cancer is large bowel cancer. 25. The method for treating cancer according to claim 4, wherein the cancer is gastrointestinal cancer. 26. The method for treating cancer according to claim 4, wherein the cancer is breast cancer. 27. The method for treating cancer according to claim 5, wherein the cancer is gastrointestinal cancer or breast cancer. 28. The method for treating cancer according to claim 5, wherein the cancer is large bowel cancer. 29. The method for treating cancer according to claim 5, wherein the cancer is gastrointestinal cancer. 30. The method for treating cancer according to claim 5, wherein the cancer is breast cancer.

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