US2008051380A1PendingUtilityA1

Methods and compositions for treating cancer

59
Individually held — no corporate assignee on recordPriority: Aug 25, 2006Filed: Aug 24, 2007Published: Feb 28, 2008
Est. expiryAug 25, 2026(~0.1 yrs left)· nominal 20-yr term from priority
Inventors:Alan H. AuerbachArie S. Belldegrun
A61P 35/00A61K 31/58A61K 31/573
59
PatentIndex Score
0
Cited by
0
References
0
Claims

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

exact text as granted — not AI-modified
1 . A method for the treatment of a cancer in a mammal comprising administering a therapeutically effective amount of at least one 17α-hydroxylase/C 17,20 -lyase inhibitor and a therapeutically effective amount of at least one additional therapeutic agent to a patient having a cancer; wherein the 17α-hydroxylase/C 17,20 -lyase inhibitor comprises a compound of the formula (I) or an analog, a derivative, a metabolite or a pharmaceutically acceptable salt thereof,  
     
       
         
         
             
             
         
       
     
     wherein R represents a hydrogen, or an acyl group having 1-4 carbons.  
   
   
       2 . The method of  claim 1 , wherein the 17α-hydroxylase/C 17,20 -lyase inhibitor comprises abiraterone acetate or an analog, a derivative, a metabolite or a pharmaceutically acceptable salt thereof.  
   
   
       3 . The method of  claim 2 , wherein the 17α-hydroxylase/C 17,20 -lyase inhibitor comprises the mesylate salt of abiraterone acetate.  
   
   
       4 . The method of  claim 1 , wherein the therapeutically effective amount of the 17α-hydroxylase/C 17,20 -lyase inhibitor comprises about 50 mg/day to about 2000 mg/day.  
   
   
       5 . The method of  claim 1 , wherein the additional therapeutic agent comprises an anti-neoplastic agent, an alkylating agent, an anti-metabolite agent, an antibiotic agent, a hormonal ablation agent, an androgen ablation agent, an anti-androgen agent, or a steroid.  
   
   
       6 . The method of  claim 1 , wherein the additional therapeutic agent comprises mitoxantrone, paclitaxel, docetaxel, leuprolide, goserelin, triptorelin, seocalcitol, bicalutamide, flutamide, hydrocortisone, prednisone or dexamethasone.  
   
   
       7 . The method of  claim 1 , wherein the 17α-hydroxylase/C 17,20  lyase inhibitor and the additional therapeutic agent are administered to the mammal in a single composition comprising the 17α-hydroxylase/C 17,20  lyase inhibitor and the additional therapeutic agent.  
   
   
       8 . The method of  claim 1 , wherein the 17α-hydroxylase/C 17,20  lyase inhibitor and the additional therapeutic agent are administered separately to the mammal.  
   
   
       9 . The method of  claim 1 , wherein the cancer is prostate cancer or breast cancer.  
   
   
       10 . The method of  claim 1 , wherein the therapeutically effective amount of the at least one 17α-hydroxylase/C 17,20 -lyase inhibitor comprises about 0.01 mg/kg/day to about 100 mg/kg/day of abiraterone acetate and the therapeutically effective amount of the at least one additional therapeutic agent comprises about 0.1 mg/m 2  to about 20 mg/m 2  of mitoxantrone.  
   
   
       11 . The method of  claim 1  wherein the therapeutically effective amount of the at least one 17α-hydroxylase/C 17,20 -lyase inhibitor comprises about 0.01 mg/kg/day to about 100 mg/kg/day of abiraterone acetate and the therapeutically effective amount of the at least one additional therapeutic agent comprises about 1 mg/m to about 175 mg/m 2  of paclitaxel.  
   
   
       12 . The method of  claim 1  wherein the therapeutically effective amount of the at least one 17α-hydroxylase/C 17,20 -lyase inhibitor comprises about 0.01 mg/kg/day to about 100 mg/kg/day of abiraterone acetate and the therapeutically effective amount of the at least one additional therapeutic agent comprises about 1 mg/m 2  to about 100 mg/m 2  of docetaxel.  
   
   
       13 . The method of  claim 1  wherein the therapeutically effective amount of the at least one 17α-hydroxylase/C 17,20 -lyase inhibitor comprises about 0.01 mg/kg/day to about 100 mg/kg/day of abiraterone acetate and the therapeutically effective amount of the at least one additional therapeutic agent comprises about 0.01 to about 200 mg of leuprolide over a period of about 3 days to about 12 months.  
   
   
       14 . The method of  claim 1  wherein the therapeutically effective amount of the at least one 17α-hydroxylase/C 17,20 -lyase inhibitor comprises about 0.01 mg/kg/day to about 100 mg/kg/day of abiraterone acetate and the therapeutically effective amount of the at least one additional therapeutic agent comprises about 20 mg of goserelin over a period of about 28 days to about 3 months.  
   
   
       15 . The method of  claim 1  wherein the therapeutically effective amount of the at least one 17α-hydroxylase/C 17,20 -lyase inhibitor comprises about 0.0 1 mg/kg/day to about 100 mg/kg/day of abiraterone acetate and the therapeutically effective amount of the at least one additional therapeutic agent comprises about 0.01 mg to about 20 mg of triptorelin over a period of about 1 month.  
   
   
       16 . The method of  claim 1  wherein the therapeutically effective amount of the at least one 17α-hydroxylase/C 17,20 -lyase inhibitor comprises about 0.01 mg/kg/day to about 100 mg/kg/day of abiraterone acetate and the therapeutically effective amount of the at least one additional therapeutic agent comprises about 0.1 μg/day to about 500 μg/day of seocalcitol.  
   
   
       17 . The method of  claim 1  wherein the therapeutically effective amount of the at least one 17α-hydroxylase/C 17,20 -lyase inhibitor comprises about 0.01 mg/kg/day to about 100 mg/kg/day of abiraterone acetate and the therapeutically effective amount of the at least one additional therapeutic agent comprises about 1 mg/day to about 300 mg/day of bicalcutamide.  
   
   
       18 . The method of  claim 1  wherein the therapeutically effective amount of the at least one 17α-hydroxylase/C 17,20 -lyase inhibitor comprises about 0.01 mg/kg/day to about 100 mg/kg/day of abiraterone acetate and the therapeutically effective amount of the at least one additional therapeutic agent comprises about 1 mg/day to about 2000 mg/day flutamide.  
   
   
       19 . The method of  claim 1  wherein the therapeutically effective amount of the at least one 17α-hydroxylase/C 17,20 -lyase inhibitor comprises about 50 mg/day to about 2000 mg/day of abiraterone acetate and the therapeutically effective amount of the at least one additional therapeutic agent comprises about 10 mg/day to about 250 mg/day of hydrocortisone.  
   
   
       20 . The method of  claim 1  wherein the therapeutically effective amount of the at least one 17α-hydroxylase/C 17,20 -lyase inhibitor comprises about 50 mg/day to about 2000 mg/day of abiraterone acetate and the therapeutically effective amount of the at least one additional therapeutic agent comprises about 10 mg/day to about 250 mg/day prednisone.  
   
   
       21 . The method of  claim 1  wherein the therapeutically effective amount of the at least one 17α-hydroxylase/C 17,20 -lyase inhibitor comprises about 50 mg/day to about 2000 mg/day of abiraterone acetate and the therapeutically effective amount of the at least one additional therapeutic agent comprises about 0.5 mg/day to about 25 mg/day dexamethasone.  
   
   
       22 . A method for treating a patient having a refractory prostate or breast cancer who is currently receiving at least one treatment for cancer, the method comprising administering a therapeutically effective amount of at least one 17α-hydroxylase/C 17,20 -lyase inhibitor in addition to the at least one treatment the patient is currently receiving, wherein the 17α-hydroxylase/C 17,20 -lyase inhibitor comprises a compound of the formula (I) or an analog, a derivative, a metabolite or pharmaceutically acceptable salt thereof,  
     
       
         
         
             
             
         
       
     
     wherein R represents a hydrogen, or an acyl group having 1-4 carbons.  
   
   
       23 . The method of  claim 22 , wherein the 17α-hydroxylase/C 17,20 -lyase inhibitor comprises abiraterone acetate or an analog, a derivative, a metabolite or a pharmaceutically acceptable salt thereof.  
   
   
       24 . The method of  claim 23 , wherein the 17α-hydroxylase/C 17,20 -lyase inhibitor comprises the mesylate salt of abiraterone acetate.  
   
   
       25 . The method of  claim 22 , wherein the therapeutically effective amount of the 17α-hydroxylase/C 17,20 -lyase inhibitor comprises about 50 mg/day to about 2000 mg/day.  
   
   
       26 . The method of  claim 22 , wherein the treatment for cancer comprises the administration of an anti-cancer agent, chemotherapy, radiation or surgery.  
   
   
       27 . A pharmaceutical composition for the treatment of a cancer in a mammal comprising a therapeutically effective amount of at least one 17α-hydroxylase/C 17,20 -lyase inhibitor; and at least one additional therapeutic agent; wherein the 17α-hydroxylase/C 17,20 -lyase inhibitor comprises a compound of the formula (I) or an analog, a derivative, a metabolite or a pharmaceutically acceptable salt thereof,  
     
       
         
         
             
             
         
       
     
     wherein R represents a hydrogen, or an acyl group having 1-4 carbons.  
   
   
       28 . The composition of  claim 27 , wherein the 17α-hydroxylase/C 17,20 -lyase inhibitor comprises abiraterone acetate or an analog, a derivative, a metabolite or a pharmaceutically acceptable salt thereof.  
   
   
       29 . The composition of  claim 28 , wherein the 17α-hydroxylase/C 17,20 -lyase inhibitor comprises the mesylate salt of abiraterone acetate.  
   
   
       30 . The composition of  claim 27 , wherein the therapeutically effective amount of the 17α-hydroxylase/C 17,20 -lyase inhibitor comprises about 50 mg to about 500 mg.  
   
   
       31 . The composition of  claim 27 , wherein the additional therapeutic agent comprises mitoxantrone, paclitaxel, docetaxel, leuprolide, goserelin, triptorelin, seocalcitol, bicalutamide, flutamide, hydrocortisone, prednisone or dexamethasone.  
   
   
       32 . A pharmaceutical composition for the treatment of a cancer in a mammal comprising a therapeutically effective amount of abiraterone acetate; and a therapeutically effective amount of a steroid, wherein the composition is suitable for oral administration.  
   
   
       33 . The composition of  claim 32  wherein the composition is a solid dosage form.  
   
   
       34 . The composition of  claim 32 , wherein the composition comprises about 50 mg to about 500 mg of abiraterone acetate, and about 0.25 mg to about 3.5 mg of the steroid.  
   
   
       35 . The composition of  claim 32 , wherein the steroid comprises hydrocortisone, prednisone, or dexamethasone.  
   
   
       36 . The composition of  claim 32 , wherein the composition is in the form of a pill, tablet or capsule.

Join the waitlist — get patent alerts

Track US2008051380A1 — get alerts on status changes and closely related new filings.

We store only your email — no account needed. See our privacy policy.