Methods and Compositions for Treating Cancer

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.

1 - 86 . (canceled) 
     
     
         87 . 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 dexamethasone. 
     
     
         88 . The method of  claim 87 , 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. 
     
     
         89 . The method of  claim 88 , 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. 
     
     
         90 . The method of  claim 89 , wherein the therapeutically effective amount of the abiraterone acetate or pharmaceutically acceptable salt thereof is about 1000 mg/day. 
     
     
         91 . The method of  claim 87 , 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. 
     
     
         92 . The method of  claim 87 , wherein the therapeutically effective amount of the dexamethasone is from about 0.01 mg/day to about 500 mg/day. 
     
     
         93 . The method of  claim 92 , wherein the therapeutically effective amount of the dexamethasone is from about 0.5 mg/day to about 25 mg/day. 
     
     
         94 . The method of  claim 93 , wherein the therapeutically effective amount of the dexamethasone is about 0.5 mg/day. 
     
     
         95 . The method of  claim 87 , 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 0.5 mg/day to about 25 mg/day of dexamethasone. 
     
     
         96 . The method of  claim 95 , comprising administering to said human about 1000 mg/day of abiraterone acetate or a pharmaceutically acceptable salt thereof and about 0.5 mg/day of dexamethasone. 
     
     
         97 . The method of  claim 87 , wherein said prostate cancer is refractory prostate cancer. 
     
     
         98 . The method of  claim 97 , wherein the refractory prostate cancer is not responding to at least one anti-cancer agent. 
     
     
         99 . The method of  claim 98 , wherein the at least one anti-cancer agent comprises a hormonal ablation agent, an anti-androgen agent, or an anti-neoplastic agent. 
     
     
         100 . The method of  claim 99 , wherein the hormonal ablation agent comprises deslorelin, leuprolide, goserelin, or triptorelin. 
     
     
         101 . The method of  claim 99 , wherein the anti-androgen agent comprises bicalutamide, flutamide, or nilutamide. 
     
     
         102 . The method of  claim 99 , wherein the anti-neoplastic agent comprises docetaxel. 
     
     
         103 . The method of  claim 98 , 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 0.5 mg/day to about 25 mg/day of dexamethasone. 
     
     
         104 . The method of  claim 103 , comprising administering to said human about 1000 mg/day of abiraterone acetate or a pharmaceutically acceptable salt thereof and about 0.5 mg/day of dexamethasone.