IP Library Granted Patent US 41,084
Granted Patent E1
US 41,084 · App. 11/645,327 · Granted Jan 19, 2010

Antineoplastic combinations

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Quick Facts
Patent No.
US 41,084
App. No.
11/645,327
Granted
Jan 19, 2010
Kind
E1
Abstract

This invention provides the use of a combination of CCI-779 and EKB-569 in the treatment of neoplasms.

Claims (42)

1. A method of treating a neoplasm in a mammal in need thereof, which comprises providing to said mammal synergistically effective amount of a combination comprising CCI-779 and EKB-569.

2. The method according to claim 1 , wherein the neoplasm is renal cancer.

3. The method according to claim 1 , wherein the neoplasm is soft tissue sarcoma.

4. The method according to claim 1 , wherein the neoplasm is breast cancer.

5. The method according to claim 1 , wherein the neoplasm is a neuroendocrine tumor of the lung.

6. The method according to claim 1 , wherein the neoplasm is cervical cancer.

7. The method according to claim 1 , wherein the neoplasm is uterine cancer.

8. The method according to claim 1 , wherein the neoplasm is a head and neck cancer.

9. The method according to claim 1 , wherein the neoplasm is glioma.

10. The method according to claim 1 , wherein the neoplasm is non-small cell lung cancer.

11. The method according to claim 1 , wherein the neoplasm is prostate cancer.

12. The method according to claim 1 , wherein the neoplasm is pancreatic cancer.

13. The method according to claim 1 , wherein the neoplasm is lymphoma.

14. The method according to claim 1 , wherein the neoplasm is melanoma.

15. The method according to claim 1 , wherein the neoplasm is small cell lung cancer.

16. The method according to claim 1 , wherein the neoplasm is ovarian cancer.

17. The method according to claim 1 , wherein the neoplasm is colon cancer.

18. The method according to claim 1 , wherein the neoplasm is esophageal cancer.

19. The method according to claim 1 , wherein the neoplasm is gastric cancer.

20. The method according to claim 1 , wherein the neoplasm is leukemia.

21. The method according to claim 1 , wherein the neoplasm is colorectal cancer.

22. The method according to claim 1 , wherein the neoplasm is unknown primary cancer.

23. A method of treating a neoplasm in a mammal in need thereof, which comprises providing to said mammal an effective amount of a synergistic combination comprising CCI-779 and EKB-569, wherein either CCI-779, EKB-569, or both are provided in subtherapeutically effective amounts.

24. The method according to claim 23 in which CCI-779 is provided in a subtherapeutically effective amount.

25. The method according to claim 23 in which EKB-569 is provided in a subtherapeutically effective amount.

26. The method according to claim 23 in which both CCI-779 and EKB-569 are provided in subtherapeutically effective amounts.

27. An antineoplastic combination which comprises an antineoplastic effective amount of a synergistic combination of CCI-779 and EKB-569.

28. A process for the preparation of 4 - dimethylamino - but - 2 - enoic acid [ 4 -( 3 - chloro - 4 - fluoro - phenylamino )- 3 - cyano - 7 - ethoxy - quinolin - 6 - yl] - amide comprising:

( a ) forming a mixture containing ( 4 - [ 3 - chloro - 4 - fluoro - phenyl]amino - 6 - amino - 3 - cyano - 7 - ethoxy - quinoline ) , 4 - N,N - dimethylaminocrotonoyl chloride hydrochloride, and N - methylpyrrolidinone at a temperature of 0 to 10 ° C.;

( b ) holding the mixture until the concentration of the ( 4 - [ 3 - chloro - 4 - fluoro - phenyl]amino - 6 - amino - 3 - cyano - 7 - ethoxy - quinoline ) is equal to or less than 2 %;

( c ) adding sodium bicarbonate to the suspension in step ( b ) until a solution is obtained;

( d ) collecting the product of step ( c ) to yield the compound 4 - dimethylamino - but - 2 - enoic acid [ 4 -( 3 - chloro - 4 - fluoro - phenylamino )- 3 - cyano - 7 - ethoxy - quinolin - 6 - yl] - amide.

29. The process according to claim 28 wherein the collecting step comprises filtering, washing and drying the product of step ( c ).

30. The process according to claim 28 , further comprising the step of preparing the 4 - N,N - dimethylaminocrotonoyl chloride hydrochloride, said step further comprising:

( i ) adding oxalyl chloride to a combination of the compound

( ii ) stirring the combination in step ( i ) at 20 to 25 ° C.;

( iii ) cooling the combination of step ( ii ).

31. The process according to claim 30 , wherein the combination in ( i ) is at 0 ° C.

32. The process according to claim 30 , wherein the cooling is to 0 ° C.

33. The process according to claim 30 , wherein the product of ( iii ) is washed with tetrahydrofuran ( THF ) and dried to yield 4 - N,N - dimethylaminocrotonoyl chloride hydrochloride.

34. The process according to claim 28 , wherein the 4 - N,N - dimethylaminocrotonoyl chloride hydrochloride is prepared in CH 3 CN.

35. The process according to claim 28 , wherein the 4 - N,N - dimethylaminocrotonoyl chloride hydrochloride is prepared in tetrahydrofuran with dimethylformamide.