Methods and compositions for treating cancer

• US 8,822,438 B2
• Filed: 02/24/2011
• Issued: 09/02/2014
• Est. Priority Date: 08/25/2006
• Status: Active Grant

• Current Assignee: British Technology Group Ltd.
• Original Assignee: JANSSEN ONCOLOGY, INC. (Johnson & Johnson)
• Inventors: Auerbach, Alan H., Belldegrum, Arie S.
• Primary Examiner(s): HUI, SAN MING R
• Application Number:
  US13/034,340
• Publication Number:
  US 20110144016A1
• Time in Patent Office: 1,286 Days
• Field of Search: 514/170, 514/182
• US Class Current: 514/170
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61P 35/00 Antineoplastic agents

Abstract

Methods and compositions for treating cancer are described herein. More particularly, the methods for treating cancer comprise administering a 17α-hydroxylase/C_17,20-lyase inhibitor, such as abiraterone acetate (i.e., 3β-acetoxy-17-(3-pyridyl)androsta-5,16-diene), in combination with at least one additional therapeutic agent such as an anti-cancer agent or a steroid. Furthermore, disclosed are compositions comprising a 17α-hydroxylase/C_17,20-lyase inhibitor, and at least one additional therapeutic agent, such as an anti-cancer agent or a steroid.

Claims

1. A method for the treatment of a prostate cancer in a human comprising administering to said human a therapeutically effective amount of abiraterone acetate or a pharmaceutically acceptable salt thereof and a therapeutically effective amount of prednisone.

2. The method of claim 1, wherein the therapeutically effective amount of the abiraterone acetate or pharmaceutically acceptable salt thereof is from about 50 mg/day to about 2000 mg/day.

3. The method of claim 2, wherein the therapeutically effective amount of the abiraterone acetate or pharmaceutically acceptable salt thereof is from about 500 mg/day to about 1500 mg/day.

4. The method of claim 3, wherein the therapeutically effective amount of the abiraterone acetate or pharmaceutically acceptable salt thereof is about 1000 mg/day.

5. The method of claim 1, wherein the therapeutically effective amount of the abiraterone acetate or a pharmaceutically acceptable salt thereof is administered in at least one dosage form comprising about 250 mg of abiraterone acetate or a pharmaceutically acceptable salt thereof.

6. The method of claim 1, wherein the therapeutically effective amount of the prednisone is from about 0.01 mg/day to about 500 mg/day.

7. The method of claim 6, wherein the therapeutically effective amount of the prednisone is from about 10 mg/day to about 250 mg/day.

8. The method of claim 7, wherein the therapeutically effective amount of the prednisone is about 10 mg/day.

9. The method of claim 1, wherein the therapeutically effective amount of the prednisone is administered in at least one dosage form comprising about 5 mg of prednisone.

10. The method of claim 1, comprising administering to said human about 500 mg/day to about 1500 mg/day of abiraterone acetate or a pharmaceutically acceptable salt thereof and about 0.01 mg/day to about 500 mg/day of prednisone.

11. The method of claim 10, comprising administering to said human about 1000 mg/day of abiraterone acetate or a pharmaceutically acceptable salt thereof and about 10 mg/day of prednisone.

12. The method of claim 1, wherein said prostate cancer is refractory prostate cancer.

13. The method of claim 12, wherein the refractory prostate cancer is not responding to at least one anti-cancer agent.

14. The method of claim 13, wherein the at least one anti-cancer agent comprises a hormonal ablation agent, an anti-androgen agent, or an anti-neoplastic agent.

15. The method of claim 14, wherein the hormonal ablation agent comprises deslorelin, leuprolide, goserelin, or triptorelin.

16. The method of claim 14, wherein the anti-androgen agent comprises bicalutamide, flutamide, or nilutamide.

17. The method of claim 14, wherein the anti-neoplastic agent comprises docetaxel.

18. The method of claim 12, comprising administering to said human about 500 mg/day to about 1500 mg/day of abiraterone acetate or a pharmaceutically acceptable salt thereof and about 0.01 mg/day to about 500 mg/day of prednisone.

19. The method of claim 18, comprising administering to said human about 1000 mg/day of abiraterone acetate or a pharmaceutically acceptable salt thereof and about 10 mg/day of prednisone.

20. The method of claim 17, comprising administering to said human about 1000 mg/day of abiraterone acetate or a pharmaceutically acceptable salt thereof and about 10 mg/day of prednisone.