Combination of a PI3 Kinase Inhibitor with Pacitaxel for Use in the Treatment or Prevention of a Cancer of the Head and Neck

Abstract

A pharmaceutical combination comprising (a) a phosphatidylinositol-3-kinase (PI3K) inhibitor compound of formula (I), as defined herein, or a pharmaceutically acceptable salt thereof and (b) paclitaxel or a pharmaceutically acceptable salt thereof for simultaneous, separate or sequential use, for the treatment of a cancer of the head and neck; a pharmaceutical composition comprising said combination; the use of said combination for the preparation of a medicament for the treatment of a cancer of the head and neck; a method of treating or preventing a cancer of the head and neck comprising administering a jointly therapeutically effective amount of such a combination to a subject in need thereof; and a commercial package thereof.

1 - 18 . (canceled) 
     
     
         19 . A method of treating or preventing a cancer of the head and neck comprising administering a jointly therapeutically effective amount of the pharmaceutical combination comprising (a) a compound of formula (I) 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof, and (b) paclitaxel or a pharmaceutically acceptable salt thereof, to a subject in need thereof. 
     
     
         20 . The method according to  claim 19 , wherein the cancer of the head and neck is selected from the group consisting of cancer or tumor of the oral cavity, lips, pharynx (including nasopharynx, oropharynx, and hypopharynx), larynx, paranasal sinuses, nasal cavity, throat and salivary glands. 
     
     
         21 . The method according to  claim 19 , wherein the cancer of the head and neck is a squamous cell carcinoma of the head and neck. 
     
     
         22 . The method according to  claim 19 , wherein the compound of formula (I) or its pharmaceutically acceptable salt is administered to the subject in a dose amount ranging from about 60 mg/day to about 120 mg/day in an adult human. 
     
     
         23 . The method according to  claim 19 , wherein the paclitaxel is administered to the subject in a dose amount ranging from approximately about 15 to 200 mg/m 2  per week in an adult human. 
     
     
         24 . The method according to  claim 19  wherein the cancer of the head and neck is resistant to prior treatment with paclitaxel, fluorouracil (5-FU), platinum-based therapies, or a combination thereof. 
     
     
         25 . A pharmaceutical combination comprising (a) a compound of formula (I) 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof, and (b) paclitaxel or a pharmaceutically acceptable salt thereof, for simultaneous, separate or sequential use, for the treatment or prevention of a cancer of the head and neck. 
     
     
         26 . The pharmaceutical combination according to  claim 25  wherein the compound of formula (I) or its pharmaceutically acceptable salt is administered in a dose amount ranging from about 60 mg/day to about 120 mg/day in an adult human. 
     
     
         27 . The pharmaceutical combination according to  claim 25  wherein the paclitaxel is administered in a dose amount ranging from approximately about 15 to 200 mg/m 2  per week in an adult human. 
     
     
         28 . A pharmaceutical composition comprising a jointly therapeutically effective amount of a pharmaceutical combination according to  claim 25  and optionally at least one pharmaceutically acceptable carrier for use in the treatment or prevention of a cancer of the head and neck. 
     
     
         29 . A commercial package comprising the pharmaceutical combination according to  claim 25 , together with instructions for simultaneous, separate or sequential administration thereof for use in the treatment or prevention of a cancer of the head and neck.