Dosage regimen of mdm2 inhibitor for treating cancers

Abstract

The present invention provides a method for treating a cancer in a subject in need thereof, comprising administering a specific MDM2 inhibitor to the subject according to a specific dosage regimen and a pharmaceutical composition for use in treating a cancer according to the dosage regimen. The present invention also provides a method for treating liposarcoma in a subject in need thereof, comprising administering a specific MDM2 inhibitor to the subject and a pharmaceutical composition for use in treating liposarcoma, comprising the MDM2 inhibitor.

1 .- 40 . (canceled) 
     
     
         41 . A method of treating a cancer in a subject in need thereof, comprising orally administering to a subject a compound of formula (I) or a pharmaceutically acceptable salt thereof 
       
         
           
           
               
               
           
         
       
     
     
         42 . The method of  claim 41 , wherein the daily dose is 80 mg±10% to 250 mg±10% of the compound or the salt thereof. 
     
     
         43 . The method of  claim 41 , wherein the daily dose is 250 mg±10% of the compound or the salt thereof. 
     
     
         44 . The method of  claim 43 , wherein the daily dose of 250 mg±10% is 260 mg of the compound or the salt thereof. 
     
     
         45 . The method of  claim 41 , wherein the salt thereof is a p-toluenesulfonic acid salt monohydrate of formula (II) 
       
         
           
           
               
               
           
         
       
     
     
         46 . The method of  claim 41 , wherein the cancer has amplified MDM2 genes in its genome or overexpresses MDM2. 
     
     
         47 . The method of  claim 41 , wherein the cancer is a solid tumor. 
     
     
         48 . The method of  claim 41 , wherein the daily dosage is 200 mg±10% of the compound or the salt thereof. 
     
     
         49 . The method of  claim 41 , wherein the daily dosage is 160 mg±10% of the compound or the salt thereof. 
     
     
         50 . The method of  claim 41 , wherein the daily dosage is 130 mg±10% of the compound or the salt thereof. 
     
     
         51 . A method of treating a solid tumor in a subject in need thereof, comprising orally administering to a subject a compound of formula (I) or a pharmaceutically acceptable salt thereof 
       
         
           
           
               
               
           
         
       
     
     
         52 . The method of  claim 51 , wherein the daily dose is 80 mg±10% to 250 mg±10% of the compound or the salt thereof. 
     
     
         53 . The method of  claim 51 , wherein the daily dose is 250 mg±10% of the compound or the salt thereof. 
     
     
         54 . The method of  claim 53 , wherein the daily dose of 250 mg±10% is 260 mg of the compound or the salt thereof. 
     
     
         55 . The method of  claim 51 , wherein the salt thereof is a p-toluenesulfonic acid salt monohydrate of formula (II) 
       
         
           
           
               
               
           
         
       
     
     
         56 . The method of  claim 51 , wherein the cancer has amplified MDM2 genes in its genome or overexpresses MDM2. 
     
     
         57 . The method of  claim 51 , wherein the solid tumor is selected from soft tissue sarcoma, melanoma, neuroendocrine cancer, adenoid cystic cancer, leiomyosarcoma, colorectal cancer, renal cancer, lung cancer, chordoma, salivary adenocarcinoma, adrenocortical carcinoma, and maxillary sinus adenocarcinoma. 
     
     
         58 . The method of  claim 51 , wherein the daily dosage is 200 mg±10% of the compound or the salt thereof. 
     
     
         59 . The method of  claim 51 , wherein the daily dosage is 160 mg±10% of the compound or the salt thereof. 
     
     
         60 . The method of  claim 51 , wherein the daily dosage is 130 mg±10% of the compound or the salt thereof.