Method for treating cancer patients with severe renal impairment

• US 10,456,399 B2
• Filed: 08/03/2018
• Issued: 10/29/2019
• Est. Priority Date: 02/05/2016
• Status: Active Grant

• Current Assignee: Taiho Pharmaceutical Company Limited (Otsuka Holdings Company Limited)
• Original Assignee: Taiho Pharmaceutical Company Limited (Otsuka Holdings Company Limited)
• Inventors: Yoshida, Kenichiro
• Primary Examiner(s): Shiao, Rei Tsang
• Application Number:
  US16/054,073
• Publication Number:
  US 20180338976A1
• Time in Patent Office: 452 Days
• CPC Class Codes: A61K 31/506 not condensed and containing further heterocyclic rings
• CPC Class Codes: A61K 31/513 having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
• CPC Class Codes: A61K 31/7072 having two oxo groups directly attached to the pyrimidine ring, e.g. uridine, uridylic acid, thymidine, zidovudine
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 13/12 of the kidneys
• CPC Class Codes: A61P 35/00 Antineoplastic agents

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 α,α,α-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/m²/day as FTD-equivalent, into two to four times a day, and orally administering it to the patient.

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 α

,α

,α

-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/m²/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/m²/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/m²/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.