Combination treatment of cancer

Abstract

The present invention relates to a combination comprising AZD5363, or a pharmaceutically acceptable salt thereof, and at least one androgen receptor signalling modulator selected from MDV-3100 (also known as enzalutamide), AZD3514, abiraterone (or an ester prodrug thereof: e.g. abiraterone acetate), and bicalutamide; or a pharmaceutically acceptable salt thereof. Each of these combinations may be useful in the treatment of cancer. The invention also relates to pharmaceutical compositions comprising such combinations, and further relates to methods of treatment comprising the simultaneous, sequential or separate administration of AZD5363, or a pharmaceutically acceptable salt thereof, with at least one androgen receptor signalling modulator as described above, to warm-blooded animal, such as a human for the treatment of cancer. The invention also relates to a kit comprising such combinations.

1 . A combination comprising:
 AZD5363, or a pharmaceutically acceptable salt thereof;   
       with an androgen receptor signalling modulator selected from:
 MDV-3100; 
 AZD3514; 
 abiraterone, or an ester prodrug thereof; and 
 bicalutamide; 
 
       or a pharmaceutically acceptable salt thereof. 
     
     
         2 . The combination as claimed in  claim 1 , comprising AZD5363, or a pharmaceutically acceptable salt thereof; with an androgen receptor signalling modulator which is MDV-3100. 
     
     
         3 . The combination as claimed in  claim 1 , comprising AZD5363, or a pharmaceutically acceptable salt thereof; with an androgen receptor signalling modulator which is abiraterone or abiraterone acetate; or a pharmaceutically acceptable salt thereof. 
     
     
         4 . (canceled) 
     
     
         5 . The combination as claimed in  claim 1  for the treatment of cancer. 
     
     
         6 . The combination as claimed in  claim 5  wherein the cancer is prostate cancer. 
     
     
         7 . The combination as claimed in  claim 5  wherein the cancer is castrate-resistant prostate cancer. 
     
     
         8 . A kit comprising:
 (a) AZD5363, or a pharmaceutically acceptable salt, in a first unit dosage form;   (b) MDV-3100 in a second unit dosage form;   (c) container means for containing said first and second dosage forms;   and optionally, instructions for use.   
     
     
         9 . A kit comprising:
 (a) AZD5363, or a pharmaceutically acceptable salt, in a first unit dosage form;   (b) abiraterone or abiraterone acetate; or a pharmaceutically acceptable salt thereof, in a second unit dosage form;   (c) container means for containing said first and second dosage forms;   and optionally, instructions for use.   
     
     
         10 . The kit according to  claim 8 , wherein the kit is for use in the treatment of cancer. 
     
     
         11 . The kit according to  claim 8 , wherein the kit is for use in the treatment of prostate cancer. 
     
     
         12 . The kit according to  claim 10 , wherein the kit is for use in the treatment of castrate-resistant prostate cancer. 
     
     
         13 . A combination treatment comprising the simultaneous, separate or sequential administration of an effective amount of: AZD5363, or a pharmaceutically acceptable salt thereof, optionally together with a pharmaceutically acceptable diluent or carrier;
 and an effective amount of MDV-3100, optionally together with a pharmaceutically acceptable diluent or carrier,   to a warm-blooded animal, such as a human, in need of such therapeutic treatment, for use in the treatment of cancer.   
     
     
         14 . A combination treatment comprising the simultaneous, separate or sequential administration of an effective amount of: AZD5363, or a pharmaceutically acceptable salt thereof, optionally together with a pharmaceutically acceptable diluent or carrier;
 and an effective amount of abiraterone or abiraterone acetate, or a pharmaceutically acceptable salt thereof, optionally together with a pharmaceutically acceptable diluent or carrier,   to a warm-blooded animal, such as a human, in need of such therapeutic treatment, for use in the treatment of cancer.   
     
     
         15 . The combination treatment as claimed in  claim 13 , for the treatment of prostate cancer. 
     
     
         16 . The combination treatment as claimed in  claim 13  wherein the cancer is castrate-resistant prostate cancer. 
     
     
         17 . The combination treatment as claimed in  claim 13  wherein the cancer is metastatic castrate-resistant prostate cancer. 
     
     
         18 . The kit according to  claim 9 , wherein the kit is for use in the treatment of cancer. 
     
     
         19 . The kit according to  claim 9 , wherein the kit is for use in the treatment of prostate cancer. 
     
     
         20 . The kit according to  claim 18 , wherein the kit is for use in the treatment of castrate-resistant prostate cancer. 
     
     
         21 . The combination treatment as claimed in  claim 14 , for the treatment of prostate cancer. 
     
     
         22 . The combination treatment as claimed in  claim 14  wherein the cancer is castrate-resistant prostate cancer. 
     
     
         23 . The combination treatment as claimed in  claim 14  wherein the cancer is metastatic castrate-resistant prostate cancer.