US2004176405A1PendingUtilityA1

Methods and compounds for inhibitting MRP1

Priority: Dec 22, 1999Filed: Mar 10, 2004Published: Sep 9, 2004
Est. expiryDec 22, 2019(expired)· nominal 20-yr term from priority
C07D 471/04A61P 35/00
49
PatentIndex Score
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Claims

Abstract

The present invention further relates to a method of inhibiting MRP1 in a mammal which comprises administering to a mammal in need thereof an effective amount of a compound of formula (I).

Claims

exact text as granted — not AI-modified
We claim:  
     
         1 . A compound of formula I:  
       
         
           
           
               
               
           
         
       
       where: 
 A is a C 3 -C 8  cycloalkyl, optionally substituted 1-3 times with a C 1 -C 4  alkyl;  
 het is a five (5) membered heterocyclic ring comprising N and a second heteroatom selected from N, O, or S; 
 wherein the non-fused carbon atom of the heteroaryl ring may be optionally substituted with R b : C 1 -C 6  alkyl, optionally substituted aryl, optionally substituted heterocycle, an amino acid ester, CH 2 OH, CH 2 O-heterocycle, halo, CH 2 N 3 , CH 2 SR 1 , CH 2 NR 4 R 6 , OR 1 , SR 13 , S(CH 2 ) k -phenyl, or NR 4 R 6 ; provided that when het is pyrazole or imidazole, the saturated nitrogen of the het ring may be optionally substituted with R a : C 1 -C 4  alkyl;  
 
 k is 0, 1, 2, 3, or 4;  
 n is 0, 1, or 2;  
 p is 0 or 1;  
 q is 0, 1, or 2;  
 r is 0, 1, or 2;  
 t is 0, 1, 2, 3, or 4;  
 u is 0, 1, 2, 3, or 4;  
 Y is -E-C(O)R 3 , -E-CH═CHR 13 , -E-C(OH)R 13 , -E-NR 4 R 5 , -E-OR 2 , -E-S(O) q R 13 , -E-SO 2 NR 4 R 6 , —C(R 11 )=NR 6 , or an optionally substituted heterocycle;  
 E is a bond or —C(R 11 )(R 11 )—;  
 R 1  is independently at each occurrence hydrogen or C 1 -C 6  alkyl;  
 R 2  is independently at each occurrence hydrogen, C 1 -C 6  alkyl, optionally substituted C 3 -C 8  cycloalkyl, optionally substituted (C 1 -C 4  alkyl)-aryl, optionally substituted aryl, or optionally substituted heterocycle, C(O)-aryl, or (CH 2 ) 2 NR 4 R 5 ;  
 R 3  is independently at each occurrence hydrogen, C 1 -C 6  alkyl, optionally substituted C 3 -C 8  cycloalkyl, optionally substituted (C 1 -C 4  alkyl)-aryl, optionally substituted aryl, optionally substituted heterocycle, OR 13 , or NR 4 R 6 ;  
 R 4  is independently at each occurrence hydrogen, C 1 -C 6  alkyl, optionally substituted (C 1 -C 6  alkyl)-aryl, optionally substituted aryl, or R 4  and R 5 , R 6 , R 6′  combine to form ═CR 1 R 14 ;  
 R 5  is independently at each occurrence hydrogen, C 1 -C 6  alkyl, C 1 -C 4  alkoxy, optionally substituted heterocycle, optionally substituted C 3 -Cg cycloalkyl, optionally substituted C 6 -C 10  bicycloalkyl, optionally substituted (C 1 -C 4  alkyl)-aryl, optionally substituted aryl, optionally substituted (C 1 -C 4  alkyl)-heterocycle, C(O)C(O)R 13 , C(O)R 7 , CH 2 R 7 , SO 2 R 8 , a moiety of the formula  
                     
  or R 4  and R 5 , together with the nitrogen to which they are attached, combine to form an optionally substituted N-heterocycle;  
 R 6  is independently at each occurrence hydrogen, C 1 -C 6  alkyl, C 1 -C 4  alkoxy, optionally substituted C 3 -C 8  cycloalkyl, optionally substituted C 6 -C 10  bicycloalkyl, optionally substituted (C 1 -C 4  alkyl)aryl, optionally substituted aryl, optionally substituted (C 1 -C 4  alkyl)-heterocyc]e, optionally substituted heterocycle, or R 4  and R 6 , together with the nitrogen to which they are attached, combine to form an optionally substituted N-heterocycle;  
 R 6′  is independently at each occurrence hydrogen, C 1 -C 6  alkyl, C 1 -C 4  alkoxy, optionally substituted C 3 -C 8  cycloalkyl, optionally substituted C 6 -C 10  bicycloalkyl, optionally substituted (C 1 -C 4  alkyl)-aryl, optionally substituted aryl, optionally substituted (C 1 -C 4  alkyl)heterocycle, optionally substituted heterocycle, (C 1 -C 4  alkyl)-OR 13 ; 
 wherein the (C 1 -C 4  alkyl) of the (C 1 -C 4  alkyl)-OR 13  may be optionally substituted from 1 to 2 times with C 1 -C 4  alkyl, optionally substituted aryl, optionally substituted heterocycle;  
 
 or R 4  and R 6′ , together with the nitrogen to which they are attached, combine to form an optionally substituted N-heterocycle;  
 R 7  is independently at each occurrence optionally substituted C 1 -C 6  alkyl, C 1 -C 6  alkoxy, (C 1 -C 4  alkoxy)-aryl, (C 1 -C 4  alkoxy)-heterocycle, (C 1 -C 4  alkoxy)SiCH 3 , optionally substituted (C 3 -C 8  cycloalkyl), optionally substituted (C 1 -C 4  alkyl)-(C 3 -Cg cycloalkyl), optionally substituted (C 1 -C 4  alkyl)-aryl, optionally substituted aryl, diphenylmethyl, optionally substituted (C 1 -C 4  alkyl)-CO-aryl, optionally substituted CO-aryl, optionally substituted (C 1 -C 4  alkyl)-heterocycle, optionally substituted CH═CH-heterocycle, optionally substituted phenoxy, optionally substituted heterocycle, optionally substituted (C 1 -C 4  alkyl)-phenoxy, (CH 2 ) t S(O) t R 1 , (CH 2 ) t C(R 12 )(R 9 )N(R 16 )(R 15 ), (CH 2 ) t C(R 12 )(R 9 )O(R 17 ), (CH 2 ) t C(R 12 )(R 9 )S(R 17 ), or NR 4 R 6 ′;  
 R 8  is independently at each occurrence optionally substituted C 1 -C 6  alkyl, optionally substituted aryl, optionally substituted (C 1 -C 4  alkyl)-aryl, optionally substituted (C 1 -C 4  alkyl)-heterocycle, or optionally substituted heterocycle;  
 R 9  is independently at each occurrence hydrogen, optionally substituted C 1 -C 6  alkyl, optionally substituted C 3 -Cg cycloalkyl, optionally substituted (C 1 -C 4  alkyl)-aryl, optionally substituted aryl, optionally substituted heterocycle, (CH 2 ) u4 C 1 -C 6  alkoxy), optionally substituted (CH 2 ) u —O—(C 3 -C 8  cycloalkyl), optionally substituted (CH 2 ) u —(C 1 -C 4  alkoxy)-aryl, optionally substituted (CH 2 ) u —O-aryl, optionally substituted (CH 2 ) u —O-heterocycle, (C 1 -C 4  alkyl)-CO 2 —(C 1 -C 6  alkyl), optionally substituted (C 1 -C 4  alkyl)-CO 2 —(C 3 -C 8  cycloalkyl), optionally substituted (C 1 -C 4  alkyl)CO 2 —(C 1 -C 4  alkyl)-aryl, optionally substituted (C 1 -C 4  alkyl)-CO 2 -aryl, optionally substituted (C 1 -C 4  alkyl)-CO 2 -heterocycle, or R 9  and R 12  can combine to form a C 3 -C 8  cycloalkyl;  
 R 10  is 0 to 4 substituents from the aryl ring independently at each occurrence hydrogen, halo, C(O)R 3 , cyano, optionally substituted heterocycle, optionally substituted aryl, C≡C—R 1 , C 1 -C 4  alkoxy, (C 1 -C 4  alkyl)-phenyl, NR 19 R 20 , or C 2 -C 6  alkenyl;  
 R 11  is independently at each occurrence hydrogen, C 1 -C 6  alkyl, optionally substituted heterocycle, optionally substituted (C 1 -C 4  alkyl)heterocycle, optionally substituted aryl, or optionally substituted (C 1 -C 4  alkyl)-aryl;  
 R 12  is independently at each occurrence hydrogen, optionally substituted C 1 -C 6  alky], optionally substituted C 3 -C 8  cycloalkyl, optionally substituted (C 1 -C 4  alkyl)aryl, optionally substituted aryl, optionally substituted (C 1 -C 4  alkyl)-heterocycle or optionally substituted heterocycle;  
 R 13  is independently at each occurrence hydrogen, optionally substituted C 1 -C 6  alkyl, optionally substituted C 3 -C 8  cycloalkyl, optionally substituted (C 1 -C 4  alkyl)-aryl, Optionally substituted aryl, CO 2 CH 2 CO 2 CH 2 CH 3 , or optionally substituted heterocycle;  
 R 14  is independently at each occurrence C 1 -C 6  alkyl or optionally substituted (C 1 -C 4  alkyl)-aryl;  
 R 15  is independently at each occurrence hydrogen, C 1 -C 6  alkyl, optionally substituted C 3 -C 8  cycloalkyl, optionally substituted C 6 -C 10  bicycloalkyl, optionally substituted (C 1 -C 4  alkyl)-aryl, optionally substituted aryl, optionally substituted (C 1 -C 4  allyl)-heterocycle, optionally substituted heterocycle, C(O)OR 13 , SO 2 R 8 , C(O)R 18 , or a moiety of the formula  
                     
 R 16  is independently at each occurrence hydrogen, optionally substituted C 1 -C 6  alkyl, optionally substituted aryl, optionally substituted heterocycle, or —COR 8 ; or R 16  and R 15 , together with the nitrogen to which they are attached, combine to form an optionally substituted N-heterocycle;  
 R 17  is independently at each occurrence hydrogen, optionally substituted C 1 -C 6  alkyl, optionally substituted C 3 -C 8  cycloalkyl, optionally substituted (C 1 -C 4  alkyl)-aryl, optionally substituted aryl, COR 18 , optionally substituted heterocycle, optionally substituted (C 1 -C 4  alkyl)-heterocycle, optionally substituted C 1 -C 6  alkoxy, optionally substituted (C 1 -C 4  alkoxy)-aryl, optionally substituted (C 1 -C 4  alkoxy)-heterocycle, (C 1 -C 4  alkyl)-N(R 1 )(R 1 ), or an amino acid ester;  
 R 18  is independently at each occurrence hydrogen, optionally substituted C 1 -C 6  alkyl, optionally substituted C 3 -C 8  cycloalkyl, optionally substituted (C 1 -C 4  alkyl)-aryl, optionally substituted aryl, optionally substituted heterocycle, (C 1 -C 4  alkyl)-NHCO 2 —(C 1 -C 4  alkyl), or optionally substituted (C 1 -C 4  alkyl)-heterocycle;  
 R 19  is independently at each occurrence hydrogen, or optionally substituted C 1 -C 6  alkyl;  
 R 20  is independently at each occurrence hydrogen, optionally substituted C 1 -C 6  alkyl, CH 201 , CO—(C 1 -C 4  alkyl); or a pharmaceutical salt thereof.  
 
     
     
         2 . The compound of  claim 1  where het is  
       
         
           
           
               
               
           
         
       
     
     
         3 . The compound of  claim 1  where het is  
       
         
           
           
               
               
           
         
       
     
     
         4 . The compound of any one of claims  1 - 3  where A is 1,3-cyclohexyl.  
     
     
         5 . The compound of any one of claims  14  where n is 0.  
     
     
         6 . The compound of any one of claims  1 - 5  where o is 0 or 1.  
     
     
         7 . The compound of any one of claims  1 - 6  where Y is E-NR 4 R 5 .  
     
     
         8 . The compound of  claim 7  where R 5  is COR 7 .  
     
     
         9 . The compound of  claim 8  where R 7  is optionally substituted heterocycle.  
     
     
         10 . The compound of  claim 8  where R 7  is optionally substituted CO-aryl.  
     
     
         11 . The compound of  claim 8  where R 7  is optionally substituted CO-heteroaryl.  
     
     
         12 . The compound of  claim 8  where R 7  is. (CH 2 ) t C(R 12 )(R 9 )N(R 16 )(R 15 ).  
     
     
         13 . The compound of any one of claims  1 - 12  where R b  is C 1 -C 6  alkyl.  
     
     
         14 . The compound of  claim 13  where R b  is methyl.  
     
     
         15 . The compound of any one of claims  1 - 14  where R 10  is halo.  
     
     
         16 . The compound of  claim 15  where R 10  is chloro.  
     
     
         17 . The compound of  claim 16  where R 10  is 9-chloro.  
     
     
         18 . The compound of  claim 17  selected from the group consisting of N-[(3S,1R)-3-(9-chloro-3-methyl-4-oxo-5H-isoxazolo[4,3-c]quinolin-5-yl))cyclohexyl]-2-piperidylacetamide, N-[(3S,1R) 3(9-chloro-3-methyl-4-oxo-5H-isoxazolo[4,3-c]quinolin-5-yl))cyclohexyl]-2-(2-chloro(4-pyridyloxy))acetamide, N-{[(3S,1R)-3-(9-chloro-3-methyl-4-oxo-5H-imidazolo[5,4-c]quinolin-5-yl))cyclohexyl]methyl}benzamide, N-{[(1S,3R)-3-(9-chloro-3-methyl-4-oxo-5H-isoxazolo[4,3-c]quinolin-5-yl))cyclohexyl]methyl}benzamide, N-[(3S,1R)-3-(9-chloro-3-methyl-4-oxo-5H-isoxazolo[4,3-c]quinolin-5-yl))cyclohexyl]-2-hydroxy-2-phenylacetamide, N-[(3S,1R)-3-(9-chloro-3-methyl-4-oxo-5H-isoxazolo[4,3-c]quinolin-5-yl))cyclohexyl]-2(4-fluorophenyl)-2-hydroxyacetamide, N-{[(3S,1R)-3-(9-chloro-3-methyl-4-oxo-5H-isoxazolo[4,3-c]quinolin-5-yl))cyclohexyl]methyl}-3-pyridylcarboxamide, N-[(3S,1R)-3-(9-chloro-3-methyl-4-oxo-5H-isoxazolo[4,3-c]quinolin-5-yl))cyclohexyl]-2-(4-acetylpiperazinyl)-2-phenylacetamide, and N-[(1S,3R)-3-(9-chloro-3-methyl-4-oxo-5H-isoxazolo[4,3-c]quinolin-5-yl))cyclohexyl]-2-(4-acetylpiperazinyl)-2-phenylacetamde.  
     
     
         19 . A method of inhibiting MRP1 in a mammal which comprises administering to a mammal in need thereof an effective amount of a compound of formula I, as defined in  claim 1 , or a pharmaceutical salt thereof.  
     
     
         20 . The method according to  claim 19  where the mammal is a human.  
     
     
         21 . The method of any one of claims  19 - 20  where het is  
       
         
           
           
               
               
           
         
       
     
     
         22 . The method of any one of claims  19 - 20  where het is  
       
         
           
           
               
               
           
         
       
     
     
         23 . The method of any one of claims  19 - 22  where A is 1,3-cyclohexyl.  
     
     
         24 . The method of any one of claims  19 - 23  where n is 0.  
     
     
         25 . The method of any one of claims  19 - 24  where o is 0 or 1.  
     
     
         26 . The method of any one of claims  19 - 25  where Y is E-NR 4 R 5 .  
     
     
         27 . The method of  claim 26  where R 5  is COR 7 .  
     
     
         28 . The method of  claim 27  where R 7  is optionally substituted heterocycle.  
     
     
         29 . The method of  claim 27  where R 7  is optionally substituted CO-aryl.  
     
     
         30 . The method of  claim 27  where R 7  is optionally substituted CO-heteroaryl.  
     
     
         31 . The method of  claim 27  where R 7  is (CH 2 ) t C(R 12 )(R 9 )N(R 16 )(R 15 ).  
     
     
         32 . The method of any one of claims  19 - 31  where R b  is C 1 -C 6  alkyl.  
     
     
         33 . The method of  claim 32  where R b  is methyl.  
     
     
         34 . The method of any one of claims  19 - 33  where R 10  is halo.  
     
     
         35 . The method of  claim 34  where R 10  is chloro.  
     
     
         36 . The method of  claim 35  where R 10  is 9-chloro.  
     
     
         37 . The method of  claim 36  selected from the group consisting of N-[(3S,1R) 3-(9-chloro-3-methyl-4-oxo-5H-isoxazolo[4,3-c]quinolin-5-yl))cyclohexyl]-2-piperidylacetamide, N-[(3S,1R)-3-(9-chloro-3-methyl-4-oxo-5H-isoxazolo[4,3-c]quinolin-5-yl))cyclohexyl]-2-(2-chloro(4-pyridyloxy))acetamide, N-{[(3S,1R)-3-(9-chloro-3-methyl-4-oxo-5H-imidazolo[5,4-c]quinolin-5-yl))cyclohexyl]methyl}benzamide, N-{[(1S,3R)-3-(9-chloro-3-methyl-4-oxo-5H-isoxazolo[4,3-c]quinolin-5-yl))cyclohexyl]methyl}benzamide, N-[(3S,1R)-3-(9-chloro-3-methyl-4-oxo-5H-isoxazolo[4,3-c]quinolin-5-yl))cyclohexyl]-2-hydroxy-2-phenylacetamide, N-[(3S,1R) 3 -(9-chloro-3-methyl-4-oxo-SH-isoxazolo[4,3-c]quinolin-5-yl))cyclohexyl]-2-(4-fluorophenyl)-2-hydroxyacetamide, N-{[(3S,1R)-3-(9-chloro-3-methyl-4-oxo-5H-isoxazolo[4,3-c]quinolin-5-yl))cyclohexyl]methyl}-3-pyridylcarboxamide, N-[(3S,1R)-3-(9-chloro-3-methyl-4-oxo-5H-isoxazolo[4,3-c]quinolin-5-yl))cyclohexyl]-2-(4 acetylpiperazinyl)-2-phenylacetamide, and N-[(1S,3R)-3-(9-chloro-3-methyl-4-oxo-5H-isoxazolo[4,3-c]quinolin-5-yl))cyclohexyl]-2-(4-acetylpiperazinyl)-2-phenylacetamide.  
     
     
         38 . A method of inhibiting a resistant neoplasm, or a neoplasm susceptible to resistance, in a mammal which comprises administering to a mammal in need thereof an effective amount of a compound of formula I, as defined in  claim 1 , or a pharmaceutical salt thereof; in combination with an effective amount of one or more oncolytic agents.  
     
     
         39 . The method according to  claim 38  where the mammal is a human.  
     
     
         40 . The method according to  claim 39  where the oncolytic(s) is selected from: 
 camptosar, melphalan, paclitaxel, vinorelbine, mitoxantrone, doxorubicin, daunorubicin, epirubicin, vincristine, and etopsoside.  
 
     
     
         41 . The method according to  claim 39  where the neoplasm is of the Wilm's type, bladder, bone, breast, lung(small-cell), testis, or thyroid or the neoplasm is associated with acute lymphoblastic and myeloblastic leukemia, neuroblastoma, soft tissue sarcoma, Hodgkin's and non-Hodgkin's lymphomas, and bronchogenic carcinoma.  
     
     
         42 . The method of any one of claims  3941  where het is  
       
         
           
           
               
               
           
         
       
     
     
         43 . The method of any one of claims  3941  where het is  
       
         
           
           
               
               
           
         
       
     
     
         44 . The method of any one of claims  3943  where A is 1,3-cyclohexyl.  
     
     
         45 . The method of any one of claims  3944  where n is 0.  
     
     
         46 . The method of any one of claims  39 - 45  where o is 0 or 1.  
     
     
         47 . The method of any one of claims  3946  where Y is E-NR 4 R 5 .  
     
     
         48 . The method of  claim 47  where R 5  is COR 7 .  
     
     
         49 . The method of  claim 48  where R 7  is optionally substituted heterocycle.  
     
     
         50 . The method of  claim 48  where R 7  is optionally substituted CO-aryl.  
     
     
         51 . The method of  claim 48  where R 7  is optionally substituted CO-heteroaryl.  
     
     
         52 . The method of  claim 48  where R 7  is (CH 2 ) t C(R 12 )(R 9 )N(R 16 )(R 15 ).  
     
     
         53 . The method of any one of claims  39 - 52  where R b  is C 1 -C 6  alkyl.  
     
     
         54 . The method of  claim 53  where R b  is methyl.  
     
     
         55 . The method of any one of claims  39 - 54  where R 10  is halo.  
     
     
         56 . The method of  claim 55  where R 10  is chloro.  
     
     
         57 . The method of  claim 56  where R 10  is 9-chloro.  
     
     
         58 . The method of  claim 57  selected from the group consisting of N-[(3S,1R)-3-(9-chloro-3-methyl oxo-5H-isoxazolo[4,3-c]quinolin-5-yl))cyclohexyl]-2-piperidylacetamide, N-[(3S,1R)-3-(9-chloro-3-methyl-4-oxo-5H-isoxazolo[4,3-c]quinolin-5-yl))cyclohexyl]-2-(2-chloro(4-pyridyloxy))acetamide, N-{[(3S,1R)-3-(9-chloro-3-methyl-4-oxo-5H-imidazolo[5,4-c]quinolin-5-yl))cyclohexyl]methyl}benzamide, N-{[(1S,3R)-3-(9-chloro-3-methyl-4-oxo-5H-isoxazolo[4,3-c]quinolin-5-yl))cyclohexyl]methyl}benzamide, N-[(3S,1R)-3-(9-chloro-3-methyl-4-oxo-5H-isoxazolo[4,3-c]quinolin-5-yl))cyclohexyl]-2-hydroxy-2-phenylacetamide, N-[(3S,1R)-3-(9-chloro-3-methyl-4-oxo-5H-isoxazolo[4,3-c]quinolin-5-yl))cyclohexyl]-2-(4-fluorophenyl)-2-hydroxyacetamide, N-{[(3S,1R)-3-(9-chloro-3-methyl-4-oxo-5H-isoxazolo[4,3-c]quinolin-5-yl))cyclohexyl]methyl}-3-pyridylcarboxamide, N-[(3S,1R)-3-(9-chloro-3-methyl-4-oxo-5H-isoxazolo[4,3-c]quinolin-5-yl))cyclohexyl]-2-(4-acetylpiperazinyl)-2-phenylacetamide, and N-[(1S,3R)-3-(9-chloro-3-methyl-4-oxo-5H-isoxazolo[4,3-c]quinolin-5-yl))cyclohexyl]-2-(4-acetylpiperazinyl)-2-phenylacetamide.  
     
     
         59 . A pharmaceutical formulation comprising a compound of formula I, as defined in  claim 1 , or a pharmaceutical salt thereof; in combination with one or more pharmaceutical carriers, diluents, or excipients therefor.  
     
     
         60 . A pharmaceutical formulation comprising: 
 (a) a compound of formula I, as defined in  claim 1 , or a pharmaceutical salt thereof;    (b) one or more oncolytic agents; and    (c) one or more pharmaceutical carriers, diluents, or excipients therefor.    
     
     
         61 . The formulation according to  claim 60  where the oncolytic(s) is selected from: camptosar, melphalan, paclitaxel, vinorelbine, mitoxantrone, doxorubicin, daunorubicin, epirubicin, vincristine, and etopsoside.  
     
     
         62 . A use of a compound of formula I, as defined in  claim 1 , or a pharmaceutically acceptable salt thereof, for the manufacture of a medicament for inhibiting a resistant neoplasm, or a neoplasm susceptible to resistance in a mammal.  
     
     
         63 . A use of a compound of formula I, as defined in  claim 1 , or a pharmaceutically acceptable salt thereof, for the manufacture of a medicament for inhibiting MRP1.  
     
     
         64 . A use of a compound of formula I, as defined in  claim 1 , or a pharmaceutically acceptable salt thereof, for the manufacture of a medicament for inhibiting MRP1 conferred MDR in a resistant neoplasm, or a neoplasm susceptible to resistance in a mammal.  
     
     
         65 . A use of a compound of formula I, as defined in  claim 1 , in therapy.  
     
     
         66 . A pharmaceutical composition for inhibiting MRP1 in a mammal which comprises an effective amount of a compound of formula I, as defined in  claim 1 , or a pharmaceutical salt thereof.  
     
     
         67 . The composition according to  claim 66  where the mammal is a human.  
     
     
         68 . A pharmaceutical composition for inhibiting a resistant neoplasm, or a neoplasm susceptible to resistance, in a mammal which comprises administering to a mammal in need thereof an effective amount of a compound of formula I, as defined in  claim 1 , or a pharmaceutical salt thereof; in combination with an effective amount of one or more oncolytic agents.  
     
     
         69 . The composition according to  claim 68  where the mammal is a human.  
     
     
         70 . The composition according to  claim 69  where the oncolytic(s) is selected from: camptosar, melphalan, paclitaxel, vinorelbine, mitoxantrone, doxorubicin, daunorubicin, epirubicin, vincristine, and etopsoside.  
     
     
         71 . The composition according to  claim 69  where the neoplasm is of the Wilm's type, bladder, bone, breast, lung(small-cell), testis, or thyroid or the neoplasm is associated with acute lymphoblastic and myeloblastic leukemia, neuroblastoma, soft tissue sarcoma, Hodgkin's and non-Hodgkin's lymphomas, and bronchogenic carcinoma.

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